“But overseas, the F.D.A. has opted to announce the vast majority of its foreign inspections in advance. Overseas plants even “invite” the F.D.A. to inspector” Is this a joke? Is the FDA a joke? This is what you get from unregulated pure capitalism. With current forces at play consumer protection will never happen. Vote people vote!!!!
491
This is the kind of article that I wish all my conservative friends would read as they rant about “government being the problem” and “deregulation.”
Capitalism, with proper regulation, is always the best course.
467
Another great American export industry we destroyed and gave away to foreign generic companies.
264
This is the kind of issue that Dems could use to win elections, NOT Buttigieg's pandering to "oppression" and "privilege" in another story in today's NYT.
Under no circumstances will I vote for a comparative-oppression-privilege virtue signaler like Buttigigieg or almost all the other Dem candidates.
Nor will I vote for a nauseatingly ambitious say-anything proto-socialist like Warren.
Where's the centrist who thinks government can protect us if properly funded and kicked to do it right? Only Bloomberg, which the know-it-all commentators here loathe.
89
Not only is this unfettered capitalism but it is a security risk when we don't produce the drugs Americans need. No antibiotics made in the US now. Where are the vaccines made? The US has become a giant cash register for the wealthy ....cha-ching!
211
"Some of the plants used hidden laboratories, secretly repeated tests and altered results to produce fake data that fundamentally misrepresented drug quality, then submitted that data to regulators."
Sounds like Elizabeth Holmes' Best Practices...
101
I live in southern Arizona. I'm in my early 60's and have had many health issues over the years. I take 8 medications daily. I was born with several health issues, have never smoked, and kept my weight down all my life. My conditions are nothing that I have "brought on myself".
And so that I might afford my medications, I travel to Mexico (luckily a short drive) 2-3 times a year. I have done this for the past thirty-five years. I have never once had a problem with any of my medications -- tablets, capsules, inhalers, sprays, you name it. They have all been fine, and worked as they are supposed to do. I literally pay one-tenth the amount -- or less in some cases -- that I would have to pay here in the U.S.
I honestly think that Americans have been unduly frightened by those who have an interest in the status quo (big Pharma and Republicans, primarily). Of course I'm speaking of my own experience only. But given the length of time I've purchased these medications, and the variety of different medications, I do think my situation is instructive.
I would urge anyone who lives fairly close to the Mexican border to research medication prices.
And the fact is, I have retirement funds because I didn't - and don't - need to spend half my monthly income on my medications.
197
Four days ago, as usual, I split my warfarin 5 mg pill to add to the second 5 mg pill. M and F I take the extra half pill.
Unfortunately I instantly swallowed it. And just as fast it was as if I had eaten red hot Indian spice. My tongue and throat burned until I fell asleep half an hour later.
I took the half a pill left and the bottle, but the VA pharmacist said he had no way to examine it. Instead we tossed the bottle away.
Have not has any problem with it before nor since. We suspect it was something on the coating. But I am now very careful to pause before swallowing. God help me if it were messed up inside and I did not take it. It is really serious if warfarin is taken with spicy food and an ulcer occurs. So no more of my beloved Korean and Indian spicy fluids.
Quality control is worse than useless if not honest, whether in India or at Boeing.
81
We should not only be concerned about drug makers, doctors and big pharma. Pharmacies are also a major worry. Here is an example of abuse. I have been paying $7.00 co-payment for 90 tablets of Finasteride. I had misplaced the vial with this drug. I was not due for refill for another two weeks. I did not want to go that long without my medication. I went to Walgreens and I requested only seven tablets. Walgreens surprised me by charging $40.00 for the seven tablets.
58
Surely the manufacture of generic drugs in the USA could come under the rubric of "necessary for the national security", and made mandatory in all of its processes. This and a stricter enforcement of drug patents (without extensions) would not only ensure the safety of the public, but would provide jobs for hundreds of thousands of workers. Throw in items like negotiated prices of drugs for Medicare and other groups and the health of both our economy and of its citizens could benefit.
136
The push on the part of some in Congress to have Americans covered by generic drugs is part of a political ploy to turn people against big pharmaceutical companies. Yes, the price of certain drugs are very high due to the nature of many of the illnesses which those drugs check or control. There are certain ailments which only brand-name drugs will control. I know because I have been treated with generic drugs for a condition I have which requires daily ingestion of medication. Generics did not control my condition and thankfully, with the brand name drug, my condition has been under control for a number of years. Are these medications expensive? Yes. However, My family and I work to pay whatever it costs knowing that I have the medication which I require. Generics have been passed off as the same as the brandname at lower costs. This is simply untrue. If many in Congress, those running for president who are selling Medicare for All, and supporters of many features of the ACA succeed, l fear we will all be placed on generic drugs with the resultant loss of needed medicinal care.
The answer is not to deprive the patient in need of the correct medication but to deal with and confront the pharmaceutical companies who set the costs of the drugs.
43
We should manufacture all our own drugs. Besides the purity of the product, I have a problem relying on other countries who may or may not always be our friend.In case of a worldwide epidemic they may not deliver.
144
I've also experienced notable differences in effectiveness between name brand and generic meds. And when I've asked the doc, the pharmacist, or the insurance company about switching back to name brand, I've been poo-poo'd and patronizingly told there is no difference, it's all in my head. Thank you NYTimes for this article; one more piece of evidence that it's not me that's crazy.
265
Your drugs are made overseas now, virtually all of them.
51
I have experienced very uneven results and unintended and troubling side effects from several generics. Some generics like the one for Pristique and other SSRI and SNRI equivalents do not work at all. This is a common complaint.
My policy is as follows: if I am prescribed a drug for a minor illness like, for example, a sinus infection, I will accept it in a generic form. For anything else, my doc(s) must prescribe the brand name. Then, I have to have several unpleasant phone conversations with incompetent 3rd-World idiots from CVS to inform them that I am not taking a generic drug and why. Period. My drug plan has a $45 copay/30 days for quite a few brand names in the formulary...but, in the last few years, many of the pricey, newest “as seen on TV” drugs aren’t listed at all. Fortunately, at 70, I’m pretty healthy but I also live on a budget. I dread the thought of needing a drug that is so outrageously priced that I’d have to exhaust my savings to buy the brand name or suffer the consequences or lack thereof of the generic if one is available. I wish the FDA took these efficacy discrepancies between generic and brand names seriously and vigorously required manufacturers both here and overseas to make them equivalent to each other. Isn’t it their job to ensure Americans are getting prescribed drugs that are both effective and safe?
80
Only buy drugs from a trusted source. I recommend the guy in the alley behind the liquor store down the block.
62
Where are vaccines made?
30
This is absolutely shocking, and disgusting. Shame on the FDA.
88
We live in the Wild West of unfettered capitalism whose motto is caveat emptor, Latin for 'good luck, sucker'.
111
And politicians have the chutzpah to suggest that re importing drugs from Canada is too dangerous.
223
Hi Katherine
Are u lay directly or indirectly by big pharma or lobbyists?
Can u provide full disclosure before I believe your one sided narrative
Fact is poorer countries and their citizens depend on cheaper generics but I do not heard of mass deaths ?
Good to have both sides of the story, just like pills from bad pharma can kill, oh..just saying and trying to pass fake news as heresay
I rest my case
19
Blame the American generic drug executives! They shipped drug manufacturing overseas. Hahaha hahaha: they are laughing all the way to the bank. Nobody cares if you are poisoned by these drugs.
51
So basically cheap drugs from India and China are probably junk. Who knew? Free trade is a sham because those countries are loaded with scams and sleazy manufacturers - who in their right mind doesn’t know that already?
73
Great work Katherine!
29
This is a two edged knife being presented here.
On the one edge, there are real issue with fraud in the drug supply chains and the FDA needs to be held accountable for consumer safety in the supply chain.
The other edge though.... reads like a deliberate ploy by Big Pharma to insure articles like this panic the population such that they go to their doctors and demand brand name drugs in their prescriptions.
Both edges are despicable and co-exist in a generally corrupt medical supply chain in the US healthcare system.
People need to be aware that as consumers... we are actually cattle with wallets......that exist simply to fill the deep pockets of both Big Pharma, and all the generic drug companies around the world.
65
As usual, our government regulations are “assisted” by those they regulate (Boeing anyone?) and our public pays a price. And Congress does NOTHING.
49
It is time Americans opened their eyes and completely rethink trusting and doing business with India- One of the most corrupt, filthy and fraudulent country in the world today. Our corporations out of greed have outsourced all our data to India where it is stolen, sold and misused by these call centers in all kinds of scams including posing as IRS inspectors and endless robocalling . All our intellectual property has been accesses because of their dominance in our IT industry. Very few Americans go for computer degrees, because they do not know that tomorrow their job will be outsourced or replaced by Indians from Bangalore or Hyderabad. Naive Americans are dealing with Indian businesses majority of whom will cheat, lie and defraud any one for the sake of money, who have no moral qualms or ethics and will go even to the extent of adulterating food, medicine and spices. Imagine getting your medicines from a country where two out of every three Indians ( including babies) drink milk, adulterated with detergent, caustic soda, urea and paint.
https://economictimes.indiatimes.com/news/et-explains/is-the-milk-you-are-having-safe-heres-what-you-need-to-know/articleshow/66119023.cms
52
This is a cheap way to spread fear, uncertainty, and doubt about cheaper healthcare.
Non generics are literally made in the same places.
Like, for example take Modafinil. Both are made by reputable Indian manufacturers. Both cost a similar price. Both are available under Australia's PBS.
That's the thing, sure, there may be issues at plants that produce generic drugs, but those same plants produce for other wholesalers, that then get repackaged as name brands. There's no "artisanal" pharmaceuticals and it's giant Indian and Chinese businesses that synthesise/manufacture the components each step along the supply chain before some American, German or Singaporean company has it run through a name brand pill press and rebadges that ish. Another example is DXM. You can buy it as a powder from the same wholesaler that would sell to Robitussin.
31
This just confirms my clinical impression. Too often generic drugs are dangerous, ineffective, or both. Our political elite—who don’t usually have to use generic drugs—can’t see that cheap drugs that lead to sickness is in fact leads to much more expensive medical care. Yet...it’s actually even worse than that. Psychiatrically, if a generic drug fails I am left in a quandary. Did it fail because my hypothesis is wrong? Or was the drug defective? I can sometimes do blood levels (at great expense) and am shocked sometimes by inappropriately low levels. But another quandary: is it a bad drug, non-compliance, or genetic problems with metabolism. Another few thousands in pharmaco-genomic testing. And so on. I used to have faith in the drug supply. Sadly, no longer. And all for the sake of politics and/or kickbacks. Tragic how far we have fallen!
55
This article literally made me physically sick & nauseated. I take several prescriptions daily. I have been repeatedly pushed by insurance companies or cost from utilizing brand prescriptions to generics, and then pushed by "drug store chains" from one generic to another. There is an absolute difference from the brand to the generic. I have had bad reactions to generics & they have not worked effectively. Now drug stores are switching consumers (patients) from one generic to another without first informing & requesting consent. Again in my case, finding reactions or less efficacy to these. This is unconscionable. Drugs also react differently to different people. Others have only taken a generic, cannot compare to a brand drug. A better monitoring system needs to exist. Most disturbing is the willingness of the pharmaceutical, insurance & drug store industries' willingness to sacrifice the health & safety of the public & nation for the profits of their CEO's & corporations. The willingness of our government & the FDA to be complicit in allowing this fraud to take place with its lack of oversight & lack of restrictions their manufacturing overseas. Drug use, abuse, transport & sales have some of the strictest laws. The same should be expected of its manufacture. It cannot not be done overseas & can easily be brought back to the US. Corporate profit must take a hit & not the health & welfare of the US citizens. Corporations will still see financial profit.
47
I recently questioned the ingredients in a generic version of a drug I am taking for treatment of cancer. I have been told that the "other ingredients" in generic versions of drugs are not all the same and FDA does no testing at all of the effect of these additives on the active ingredient in generics. Only the brand name drug, with its "other ingredients", is tested by FDA.
If this is true--sounds like FDA needs to revise its testing procedures and standards.
46
Republicans want to release business from “burdensome government regulations” - this article shows the results. Please note this issue isn’t limited to pharmaceuticals - the financial markets have the same problem.
Deregulation, tax cuts, and shrinking government are killing us.
127
We don't have to take these foreign made generics. It's a little known fact that the US shouldering the cost burden for the entire world. The same drugs are cheaper in Canada because Canada has a formulary that regulates prices in their country. It's time for the US to make our drugs here, raise the prices slightly in export countries and bring US prices to their level. Enough is enough!
70
Why is it okay for FDA to get generics from India and China but it is not okay to get drugs from Canada where more stringent rules apply?
116
Because most of the drugs someone will get from Canada are also made in India and China
24
Formerly I obtained a blood pressure medication from Walgreen's and every time the script was filled, it was a different generic from India. I asked for generic that wasn't from India, which has massive quality control issues, but they couldn't do it. Instead I now buy from an on-line pharmacy that sells generics made for the eastern European markets, no quality issues and cheap.
38
This makes for eye opening reading and thank you to the New York Times. I lived in Asia and I read regular reports that were just as bad or worse, eg where no active pharmaceutical ingredient was included in Chinese or Indian manufactured products to save cost. I would only add that up until the 1990s we had a solid generic drug manufacturing industry in the US — until that industry copied the same cheap overseas manufacturing model as other industries. While I understand the pocketbook rationale why we want cheaper underwear and household goods, I will never understand why we would put our health at risk to save a few pennies a pill and at the same time manage to lose tens of thousands of good manufacturing jobs. I also have to single out the FDA - while they were making life tough for those US manufacturing plants, the owners believe the FDA wasn’t going to invest the resources to inspect overseas plants. When they finally did, we just discovered what should have been obvious all along.
91
I was prescribed a medication that worked fine while at the hospital. I returned home and was given a generic. It made me sick. I told the pharmacist, they said the "filler" may be different but the drug is the same. I said, "It's making me sick." They said you paid for 90 days and we don't take returns. If I buy the original drug from the original manufacturer, insurance would not pay. 500 plus dollars. So I basically limited my use and waited until I could refill. Our nation is literally trying to kill us.
107
This article is about generics, but what a brand name? Is there any reason to think there aren't the same problems? They are predominantly manufactured in the same countries, China and India.
30
@Elliot Actually, even if the drug were manufactured in the U.S., the ingredients are often sourced from China. So there's that too. It's about time people started paying attention.( It's been on my radar for at least the past five years.)
65
@Jeffrey Waingrow Good point. I remember reading the FDA had a problem getting into Chinese facilities as recently as 2014?(not exactly sure of the date but it wasn't that long ago). Someone else commented as to why the drug companies aren't also overseeing the facilities, not just the FDA. Whole thing is dangerous and considering how much money the drug companies make, it's incomprehensible.
33
Greed seems to have taken over the decision making process in the world. We need a major purge.
29
Opinion: American pharmaceutical patent laws have very clearly been written in the interest of both corporate financiers, and their overpaid corporate attorneys.
The company that has been pushing doctors to recommend a daily aspirin for cardiovascular disease - with zero evidence to suggest efficacy - is the same company that trademarked the name ‘Heroin’.
So, the moral of the story is that women can’t be heroes...
10
Bowing at the altar of Globalization, which is good for a few at the top, but not so much for the rest of us the US has made bad choices. One is voluntary loss of manufacturing. Not all can come back but critical areas such as this should, by mandate. I could list a few other areas as well if we were rational. It is simply personal and national interest and particularly when it comes to pharmaceuticals. That way you can ensure quality and also have critical goods made in the US and not in economic opponents such as China. Or low cost low quality ones such as India. It is all a choice.
26
I have been prescribed Synthroid for the last 20 years and the two physicians who have treated me during that time both insisted that I only take the brand-name drug, not the generic. I pay approximately $1/pill for the brand-name product vs. the generic which would cost pennies. I've never known if this was indoctrination of the endocrinologists by big pharma or if there truly is an issue with the generic Synthroid. Levothyroxine is one of the most prescribed drugs in the U.S.
18
@InAZ ~
From what I've read, your doctors are giving you good advice.
According to Ridha Aren, MD, author of "The Thyroid Solution":
"When you fill your prescription, make sure you are not given a generic preparation, since generics may not contain the exact amount of thyroid hormone prescribed." pg 254
There can be a difference of more than 10% between the various levothyroxine preparations and this is significant when treating thyroid disorders.
29
@Mary Ann Donahue. It would be wonderful if we could trust our medical professionals like Ridha Aren, MD. Let's see, we've been swindled by drug manufacturers, their sales force, the TV ads, the Doctors that prescribe the drugs, and our Congress who allow the lobbyists to write the laws so the members of Congress don't have to.
Why would we automatically
trust Dr Aren?
7
As a prescriber, I find this article disturbing in that it offers neither information about any consequences associated with subpar generics nor any possible solutions. Instead, this will do no more than to flood my office with terrified patients for whom I will not be able to do anything. Sure, I could write "DAW"(dispense as written), but no insurance will authorize a brand medication based on the allegations from this article.
32
@The F.A.D.
I agree with you, the article reiterates what many of us have known for years from similar articles. What to do next?
15
Thank you for exposing the racket in India and China. Question remains why we have not passed regulations, imposed hefty fines or banned those illegitimate manufacturers. Why they are still allowed to export the products to our country. The powers, lobbying groups in the US behind them must be investigated and exposed. This is a national security issue and impacting our nation’s health. Where are our legislators and why they are not doing anything to stop it?
36
And why the deliberate opacity regarding country of origin of the drugs that we take? Try to track down where your pill was manufactured in running into a whole lot of frustration
15
I've been told by relatives in Iran that drugs they receive in Iran from China are unreliable. There have been known cases of capsules filled with nothing but chalk.
Iran is forced to buy from China due to numerous sanctions, but why America? Can't we make our own generics?
The image of overflowing toilets next to a sterile facility in India is enough to get me off any drugs for ever.
29
Generic drugs can be just as good as name brand, but one has to be rigorous and truly care about the humans that take these medicines. This is another tragic aspect of the Republican Mantra that industries can be self regulating. No industry or system can ever be self regulating, if the public’s interest is the primary consideration.
As far as cost goes, quality assurance is pennies on the dollar compared to Fascist Big Pharma/Goverment Collusion. Quality is not magic, it just has to be the primary concern.
27
Let me get this straight, the writer of this article has created an image of the quality of generic drugs that come into this country as being shockingly deficient in quality. Millions of Americans are taking these drugs every day.
If the situation is as alarming as the writer is saying, where are the consequences? Where are the thousands of victims of this shoddy manufacturing?
If you are going to write sensational articles go the full mile. Tell us the consequences. Provide some data of the victims of these shoddy products.
17
@alan haigh
You are totally correct that we do not see the “consequences” as you put of substandard drug supply; when we should. Let me offer the following from my first hand experience working in this area for just about two decades now
1. The medical fraternity in the US is oblivious of this problem. The US FDA has done such a good job convincing us that Gx are bioequivalent to Rx that most healthcare providers dont even think of reporting lack of effect to FARES. Typical response when a patient complains about lack of effect is to switch formularies; or to write “dispense as written” on the prescription. If we dont report, how do we expect to see the consequences you so pointedly ask?
2. Their is enough physiological variability among us that many a times, lack of effect is simply ignored as “your body is not responding to this drug”
3. In cases of narrow therapeutic index drugs, which require strict BA/BE tolerance, we see this effect more pronounced. Google Wellbutrin and you will see what I mean. There are other comments about thyroid medication on this thread
4. Lastly, once the drug goes Gx, it effectively becomes an “orphan”. When it is still under patent protection, the MAH spends money trying evergreen its patent and is diligent about informing the FDA of potential unlisted Adverse Events as a part of their PSUR. Who owns the Gx product? It is manufactured typically by 6-8 Gx companies. Eg. have you seen a longitudinal study of Gx statins for long term outcomes?
24
@alan haigh: Are you serious? A person taking medication for heart disease or cancer or infection gets more sick and dies: who's going to test the medication to show an antibiotic was ineffective or that the chemotherapy killed him rather the the cancer itself? The medication is no longer even around to test. It took years to show that improper dialysis and colonoscope sterilization procedures were killing people, failures there still kill people today. Food poisoning is often not traced to its source. Faith has been defined as believing things you know aren't so, you seem to prove that.
28
Actually, millions of people ARE reported to be dying of what are called medical errors. What if those so-called errors are related to generic medicine. An ineffectual generic drug can start a cascade of error only obliquely related to the drug, but nevertheless resulting in death.
14
It's past time to nationalize pharmaceutical manufacture.
19
And the FDA’s performance inspires confidence that they could manage this?
11
Due to tensions with China stemming from the trade war, it seems a stupid idea to continue buying pharmaceutical drugs from them.
In addition, we need jobs in the US. Bring pharmaceutical manufacturing back in-country and find a way to do it affordably. Reduce executive compensation or something.
39
This after all the squawking against allowing patients to import cheaper drugs from Canada because they are allegedly untrustworthy.
34
@CH
ironic isn't it?
8
It ought to be evident to anyone that the cheap generic drugs CANNOT possibly be the same as the expensive brand-name drugs.
If the brand-name is $125, but my pharmacy says the same quantity of generic is only $3, I'd have to be an idiot to believe that I'm getting the same drug - and my own experience of taking generics has proven to me, at least, that generics are NOT of equal quality to brand name. Nor are generics from different manufacturers equal to each other.
I had a situation a couple of years ago where I had to take a certain (common) drug for 3 months:
- First month's supply was generic from manufacturer "A" and I took it without problems.
- The second month's supply was generic from manufacturer "B" and caused me to be nauseated - so, back to the pharmacy & they track down the stuff from manufacturer "A" for me.
- The third month's supply came from manufacturer "C" and it left me with a strong metallic taste in my mouth all day after taking it. Again, back to the pharmacy, which now tells me that manufacturer "A" has STOPPED making that drug - but they were kind enough to call around to their various locations and find enough from manufacturer "A" to get me through the end of the treatment.
I now have to hope never to need that drug again, b/c I have no idea what would actually be in another manufacturer's product - yet the FDA wants me to believe that "generics are all identical," which is absolute hogwash.
27
@L the active ingredient is supposed to be identical, the other incipients might not. As far as the cost, I think the name brand probably is way over priced, essentially there's no real reason why it shouldn't be similar to a generic especially after many years on the market.
8
@L Some of what you present is valid in concerns.
However.. stating: "If the brand-name is $125, but my pharmacy says the same quantity of generic is only $3, I'd have to be an idiot to believe that I'm getting the same drug - and my own experience of taking generics has proven to me, at least, that generics are NOT of equal quality to brand name. Nor are generics from different manufacturers equal to each other."
Is patently misinformed. Big Pharmas production costs for a name brand drug is pennies per dose... as is true for generics as well. The reason Big Pharma charges such high prices for patent medications is because they can.... right up and until the drug patent expires and generics are approved to enter the supply chain.
Further... while it is true that the exact formulation of a generic vs a name brand may be different... it is the non-active ingredients that are often different. Most prescription pills for example are largely fillers... as the active medication is in the milligrams yet the pills are often hundreds of milligrams in ingredients. This is why a particular medication might "taste" different to you... because the fillers are different.. yet the actual active ingredient is the same and the same dose on a properly approved generic.
5
@Chuck: Let me put it this way: I hope never to know what "filler" ingredient gave me a metallic taste in my mouth from that one manufacturer!
I'm glad I stopped taking it and went back to the pharmacy, b/c 30 days' of that filler might have proven to be very bad for me - I'll just never know!
7
Generic is cheaper for the most part because the monopolistic profit is eliminated, the abusive pricing.
How much can they possibly save by making the generic pill in India? Pennies. At most.
This is pure greed. American consumers are not benefiting from lower prices by making generic drugs in fly infested third world holes. That gets wiped away in the profit margins on even generic drugs.
26
One thing missing in this article is a clear declaration either way that the author has or does not have affiliation with the US pharmaceutical companies.
12
@s K
Exactly. It reads like marketing info from Big Pharma.
Which is not to imply that there are not issues with regulation of generic drugs.. there is.... but the reality is this article makes the average reader believe that all generic drugs are junk.
7
@s K
US pharma countries will be horrified and miffed by the this article, so the lack of affiliation is obvious. Case closed.
5
Sell! It's the American way.
1
The article is smearing the drug manufacturers in India and China on the basis of the views of one Mr Peter Baker. If the drugs being manufactured in India and China are indeed unsafe, then thousands of people in the US (and millions in India and China) should be dying everyday. Why have we not heard about thousands of lawsuits filed against the FDA and the drug manufacturers for gross negligence? The truth is that Ms Eban wants to sell a fantasy novel and every novel needs a villain and a hero. In her book, Mr Baker and she herself are the heroes and the drug makers are the villains. FDA are the comically incompetent and dirty cops.
Come on, surely the NYT can do better than this!
4
@Arvind People won't drop like flies from the kinds of deficiencies and contamination identified here. That does not mean that the medication is safe, or effective. It may take a few years of declining health before death. The death (or disability) would be attributed to whatever medical conditions are obvious.
I personally know that levothyroxine from different manufacturers give different results - over time - at identical dosages.
"Surprise" inspections visits at nursing homes have the same fraudulent activity as described here. Again personal experience. Whether it is collaboration between inspectors and the facility or inter-facility collaboration, inspection visits were known with approximately a week's notice. Staffing was upped for a week and patients who had sat in urine soaked clothing for days were washed and kept in clean clothes, urine was washed from the floors promptly instead of days later, "residents" were assisted with eating, until the inspection was over.
I have no doubts about the accuracy of Mr. Baker's investigations.
39
India and China don't need to drop a nuclear bomb on us to kill millions of Americans, they could just shut off the flow of drugs or taint them.
I though the government was supposed to protect it's citizens, guess I was taught a lie in elementary school.
15
I might red this. I may not.
What a stupid question posited. Of course they are safe. And as if all non-generics are safe?
The generics often come from the very same factories as the overpriced ones.
Millions and millions of generics are prescribed every year in this country alone. Seem to work, seem to be safe.
We all know what we pay in the US vs. every other country. Big Pharma has five, count 'em, five lobbyists on its payroll for every member of Congress.
The NYT does a disservice to the public running a shill piece like this.
6
Are generics being manufactured at all in the US? This may seem like a dumb question, but I can't find an answer. If they aren't, then why not?
13
@Mark
There may be some.. but for the most part.. no, they are made in other countries.
Reason: no US company sees any benefit in producing generics unless they have control over the pricing.. so they can reap high profit margins per dose. There are a few that produce generics for very limited market needs.. and as such... they are able to charge obscene prices because they are the only company actually producting. Remember the big scandal over Epi-pens a couple years back? Remember "pharma bro" Martin Shkreli who would buy up small generic pharma companies that sole sourced a low usage generic drugs... and then turn around and raise the prices by 1000%+ just because he could do so in the absence of any competition.
21
Recently my pharmacy switched my thyroid medicine to a different generic brand. After starting this new generic, I could barely get out of bed from the fatigue, and was very depressed. The stupor I experienced in this short period of time had a profound impact on my work and social life. I soon realized what was causing the problem and asked my doctor to switch me to brand thyroid medication, Cytomel. I had to pay out of pocket, and even with help from a discount card, the price was expensive. I am lucky I could afford it. I felt back to normal almost immediately after starting the brand medication. This experience helped me understand that there are hidden and seemingly unrelated costs in society when these generic medications are ineffective.
36
For one tablet of the antidepressant Wellbutrin XL 300 mg you can pay $71.92. Or you can pay 55 cents for the generic form. But either one may be manufactured under the shoddy conditions described in this piece. So it's distressing that the headline is we're rolling the dice with generics.
17
I you look at the prescription bottle itself, in very small letters somewhere near the name of the generic you will find the name of the lab in which it was produced. You can then look up the name of that lab to find out its location. I have had to do this on numerous occasions as my Tramadol only works generically if made by Mylan. I had to search all over my town to find one small Pharmacy that would order the Mylan brand.
11
Perhaps the companies that sell me my life-saving generics from India should also be held accountable for their drug quality? Not just the FDA.
16
@DavidDC true, all the blame on foreign companies and the FDA, but who is making all the profit? Seems strange they wouldn't look into the companies that are manufacturing their products.
11
I was the second in command of the Quality Control dept. of a big vaccine company in India exporting to 82 countries. What I witnessed made me resign from the job in five months. Batch after batch of vaccines or their components were either not potent enough or contaminated. Peter Baker's name was well known and respected at the time.
125
So many unanswered questions. Why did the FDA terminate unannouncement inspections? Why did it downgrade sanctions on the companies mentioned? Can it not detect bad drugs entering the country by chemical analysis? Has there ever been whistleblower that is a foreign national working overseas? Where, in fact, is the official FDA response because these revelations are indeed far too shocking to be printed without one.
28
As a pharmaceutical analytical chemist who has worked at two major pharmaceutical companies for 25 years and was a hired consultant for generic manufacturers, I've been saying for years that brand and generic drugs are different, no matter what the FDA says. Generic companies cut every possible corner to maximize profit and they scrimp on analytical analysis necessary to ensure the drugs have the right potency and are free of manufacturing impurities (analytical analysis is my specialty). It makes sense: brand drug manufacturers, unlike generic manufacturers, have a great deal to lose if their product is recalled.
55
@David Hughes
Potency verification of the active ingredient would seem to be the weak point for all pharmaceuticals.. including name brand patent medications.
It is the FDAs job to insure potency compliance and active ingredient accuracy in the drug supply chain.
5
One would think that American based Big Pharma companies would be out in front with promoting/publicizing such exposes of abysmal quality control (and worse) outside the country.
In addition, there are many generics manufacturers who are not based in China or India. So it would also
be instructive to have quality data from their factories. I was curious whether similar issues arise for the over the counter
drug (non prescription) market.
A natural question not investigated is how government operated European health insurance functions when it concerns the issues of quality control, violations of protocols of good manufacturing practice, and cost containment of prescription (and also over the counter) medicines.
In essence, the article seems to be describing a two tier
system of drug supply, that is, one for the upper echelon
of society who can afford medical insurance that does not obsessively push generic "equivalents", and then the other for everyone else at the mercy of their health insurance cost police.
The economic logic that dictates so much of how the society
operates implicitly promotes this type of stratification in which benefits and costs depend very much upon which
stratum one belongs to.
5
10 years or so ago the New York Times did an article on generic pharmaceutical labs in China. The focus was on how FDA officials did not want to travel the long arduous roots to the mom-and-pop labs in remote areas of China where generic drugs we're being manufactured for the US. it went on to explain about the deplorable unsanitary and unregulated conditions in these labs. After that expose we never heard much more on the subject. On a side note, I had to call every pharmacy in town just to find one that would order the one generic brand that works for me. Walmart had changed to the one that was totally ineffective.
14
What America needs, is to stop the unholy alliance between the pharmaceuticals and the politicians. Politicians of both parties get money from the pharmaceutical companies and therefore a change to cheaper negotiated drugs will never happen. I often compare the prices of the same drug from the same pharmaceutical company between my home country Sweden and the US, and it is clear that Americans are ripped off big time. This is true for generic as well as original medications.
357
@Ralph Sorbris You appear to have entirely missed a main point of the article preceding your reply—that an unintended consequence of allowing the move of generic manufacturing offshore, where the lowest of possible drug prices are attainable, has been the inability of regulatory agencies to ensure that those manufacturers are actually providing the identical chemical entity for which safety and efficacy have been studied.
That the Swedish economic system and regulatory environment, by virtue, e.g., of the decision of its electorate to allow very substantial rates of personal taxation (for instance, 49-60% of income for those earning above USD 41,600)—that this leads to differences in prices of drugs between the U.S. and Sweden is understandable. But it is irrelevant to the thrust of this article, and makes simplistic the conclusions you draw.
16
@Prof B
Sorry Professor, I agree with Ralph. It is hard to get a man to know something when his pay is dependent on him not knowing it. One could guess that sending overworked US inspectors half way around the world to inspect generics would be an invitation to disaster. It was the same with the Deep Water Horizon disaster. Why pay off inspectors when you can buy the people who appoint them.
50
My adopted country, France, has decided to force doctors and pharmacies to use generics whenever possible although it is possible to purchase the overpriced non generics if one wishes.
This article supports my g.p. insistence in avoiding the danger of poorly inspected generics by demanding the original drug product.
The same problem with defective breast implants in France caused quite a scare!
53
The solution is simply stated and difficult to achieve: Fund the FDA with the money, staff, and statutory power to make the necessary inspections.
It will take time and effort, but the world will bend to our will if they want access to our market. The only question is if the Pharma-fueled politicians have the courage to take the steps needed to make all drugs pure.
235
Having spent my childhood in India, this does not remotely surprise me. In my experience, then, and since, as well as third party data, corruption, adulteration of food and other products, and sheer sloppiness is rife. Data I have seen suggests that China may be even worse. It is hopelessly naive to put the same kind of trust into drugs made in those countries as into drugs made in the USA or Western Europe.
34
Might we create a Guantanamo Bay type prison for the fraudsters? Maybe a special CIA division to deal with the culprits? I could care less about their international-constitutional rights. I do care about my health. Americans have suffered enough at the hands of medical scam artists.
It sounds like easy pickings to me, just like we've been to them.
3
The fiasco with the recall due to cancer causing contamination of Losartan and the other Angiotensin II Receptor Blocker (ARB) group of medicines IS a front page news that is going unreported and this demands investigative reporting. I would believe that about half of all patients in the US with hypertension is affected by this recall, all health care providers are actively dealing with this recall and millions of dollars and resources are drained in this process. Alas, there is a complete silence from the media about the cause and impact of this recall and complete negligence from each and every member of Congress in protecting their constituents. Do something!
20
Less we forget that US manufactured drugs (brand and generic) use 100’s of unnecessary fillers that can be detrimental to the consumer as well. Everyone is in on the sham.
2
Some of those fillers are part of the art of medication manufacture, to allow the drug to dissolve AND disperse properly.
3
If there ever was a time to institute protectionism, this is it.
5
@caveman007...great business opportunity for an American company willing to open offices overseas to test these drugs.
4
"A low-cost drug is not a bargain if it doesn’t work." Absolutely true. What we need is drugs that have the cost of quality built in to the price.
Our research in 4 countries finds that poor quality medicines reach patients if prices are either too low, or too high. Excessively low prices incentivise sub-standard production, as described in Katherine's article. That exposes patients to substandard medicines.
Low prices also cause companies to withdraw products from low-cost markets. Shortages, together with excessively high prices, push consumers out of the regulated supply chain. That exposes patients to falsified (fake) medicines.
Research published here: https://wellcomeopenresearch.org/articles/4-70/v1
7
I don’t know who manufactures generic Zpack antibiotic but patients get diarrhea. When I mentioned it to my doctor he said he had heard that from his patients. That should be investigated as the process obviously suggests faulty procedures and it has been ongoing for years!
3
Drug companies gouge is and generics are no longer safe. Big Pharma is really having a field day. Universal health care and a serious polcy that gets the drug companies under control. It’s time to stop playing with the lives of Americans so a few billionaires both here and abroad can make more billions.
7
Made in America will not fix the problems because the raw materials come from China and India with the same bogus pedigrees that the finished drugs do. Americans pay top dollar for drugs, even the generic ones, and have a right to receive an accurate and clean version of what they are buying. The FDA is not protecting Americans as long as it allows the inspectors to be wined and dined by the corrupt drug companies.
11
@S.L. The raw materials, from where ever their source, are usually pretested by the U.S. manufacturer to meet quality control standards/raw material specs prior to their use in drug manufacturing or they are rejected.
6
For the sake of your health, never, ever ingest anything (food or medication) manufactured in India or China.
9
When this article got to the point where he reported these problems to higher-ups and nothing was done, then I knew that was where politics took over. Trump appoints FDA officials and the FDA chief, Scott Gottlieb, is still considered a shill for the pharmaceutical industry. Big Pharma has more lobbyists than anybody else. This is just one more reason vote Democrat.
7
How do we know that the same does not happen with brand drugs made in these same countries? Or with generic drugs made here?
6
Who can the American people trust? It appears we are continually lied too on a daily basis,. Will it ever stop? Doubtful at best. What's happening in our Republic when we are fed lies from the White House down Doesn't any one walk a straight line anymore?
7
Egad...
We must immediately darken the skies with planeloads of our finest FDA inspectors, to prescriptively remedy this horrible situation...
Just checked – more than a dozen 737 MAX’s could be available for chartering, within ninety minutes...
And for less than the cost of single epi-pen each...
They were certified by boatloads of our finest FAA inspectors, who – for some reason – are taking a bus to factory field inspections, these days...
Even for factories in India...
6
Mr. Baker should write a book about his experiences. A modern day "The Jungle" might emerge.
11
The FDA is -- like the FCC and the FAA -- an industry-captive. They follow in spirit what in fact is the stated mission of the USDA -- to promote sales of US agricultural product, not to inspect and certify safe and uncontaminated food.
Forget about contaminated medicines for a second and focus on approved -- and promoted -- medications that cause serious harm, such as Thalidomide (birth defects), OxyContin (addiction), Cyclofenil (Hepatotoxicity), Dantron (Mutagenic), Dexfenflura-mine (Cardiotoxic), Propoxyphene (Darvocet/Darvon -- Increased risk of heart attacks and stroke), Vioxx (cardiac problems), etc.
Common ground in a society that measures itself on mythical individual achievement over collective well-being has shrunk to the military, environment, and public health.
Thus anti-vaxers, like child pornographers, get to abuse children as political and lifestyle expression. And corporations get to self-regulate their greed even at the risk of innocent lives.
Oh and who needs government, when the marketplace with its invisible hand rewards or punishes bad players?
When the world is a place where the point of medicine is to generate massive wealth for already rich investors, why would the FDA do anything to disrupt that?
When clinical trials are actually marketing plans, we're not citizens. We're just Guinea Pigs.
10
Pharmaceutical companies should be nationalized. Most basic research is done by the government anyway then picked up by big-pharma who cannibalise the findings for obscene profit. Health is a human right and no one should profit from it least of all the greediest and the most corrupt.
16
This is one of many problems at the FDA, but a solvable one with unannounced inspections.
For those concerned about safety and health impacts, why do so many devices get approved, later to be found to be harmful? Why does FDA not require disclosure of mercury in dental amalgam fillings to patients, require written informed consent before their use, or release its patient safety warning on the product drafted for release in 2013? A growing number of other nations ban it, or restrict it from children and pregnant and nursing moms as the first step toward phaseout. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176692/
4
Well, this was to be expected isn't it? Corporate greed and government corruption as usual on this capitalist world.
Business as usual, just like the financial crisis where banks and Wall Street pay the regulatory agencies, big pharma and generic pharma pay the FDA! You can't have that!
5
@Carol
I have worked for one federal agency (17yrs) and now work with another (21yrs). I know to look at the top to see why a federal agency is not functioning. If it's not working for us, then either its weakened by Congress refusing to fund, or its regulatory purpose is being undermined by the Administration.
10
As a practicing physician, I fought to keep my patients on brand name drugs. Insurance companies denied payment, insisting generic drugs "were exactly equivalent", which I could clinically see was untrue, from less desired effectiveness to untoward reactions. But patients understandably were dismayed at the upcharge for brand name meds that resulted from insurance denials.
It will take an FDA committed to transparent and muscular protection of US patients for change to occur. Thank you to Peter Baker and other journalists and whistleblowers for shining a light on this deplorable scam. Consumers MUST BE VIGILANT!!
59
What America really needs are far fewer pharmaceuticals period. These are mainly powerful, addictive and highly synthesized substances designed to target specific symptoms, not to help our bodies come back into stasis or to promote health. Since they are studied only regarding their relationship with single organs, they come with a raft of frightening side effects and unintended consequences. Doctors who know nothing about general health prescribe them so as to appear to be doing something and because their patients are culturally trained to seek an easy fix, rather than make the hard choices which could actually improve their health. Pharmaceuticals should be a last resort in an acute situation.
8
I use a pharmacist recommended by my hospital who compounds my anticonvulsants for a reasonable fee. and delivers at no cost My brand anticonvulsant was denied by Medicare and costs over $1000 out of pocket. The compound medication is less than $100 for my 90 day supply.
6
Like some of the other commentators, I have worked in Pharmaceutical manufacturing for more than 45 years, primarily responsible for Quality activities. While some may not like to hear the following, the placement of profit motives over quality are partly cultural.
One of the first bad actors in the generic business (early 1980's) was a company in Chicago that was primarily owned by a gentleman from India. He has continued to demonstrate his greed in subsequent business activities.
Chinese concepts for hygiene were from a different world as in the 1990's, operators would urinate into an open container, while in an aseptic manufacturing facility, where sterile drug products are produced in clean rooms by operators who are supposed to be fully gowned (no exposed skin) in sterile uniforms.
Another issue created by Chinese manufacturers was the intentional contamination of Heparin with over-sulfated chondroitin sulfate (OSCS). This was first discovered in 2008 and resulted in patient deaths. The OSCS was cheaper to produce than Heparin and met all of the required Quality Control tests in place at that time. The only problem was that it did not work clincally. FDA was instrumental in the development of tests to detect this contamination.
Generic Sterile Drug Products should be produced under Government contract, similar to the production of Flu vaccine, where profit margins are fixed in the contract.
38
Would random, independent testing by multiple US based testing labs catch quality problems? If we can’t trust the manufacturer to certify quality, test after the fact and fine or ban manufacturers that fail. I would be concerned with the manufacturers paying off the independent testing labs, but utilizing multiple US based labs might make that less of an issue. The foreign companies making generics then would not need the expense of falsifying their quality data and could perhaps focus on making quality products in order to retain access to the US market.
8
@Alan Glasser Here is a thought.
How does the FAA enforce safety of aviation, especially for those carriers that are not based in the US? Clearly, we give them landing rights at our airports, but such rights are based on some form of assurance that the equipment they are flying is safe, the pilots flying that equipment are trained etc. The model works, much better than how we ensure safety of our drug supply, doesnt it? Air-accident metrics prove that this model works,
Now, think about how this model applies to what we are discussing. Does the FAA send its inspectors to countries where these flights originate for the US? The FDA seems to think that sending its inspectors to manufacturing facilities overseas is the best way to enforce quality and safety of the product they make. Clearly, inspection metrics tell us otherwise.
Why dont we use the model that works for aviation safety for public health?
6
I have Ischemic Heart Disease. I had a triple bi-pass 18 years ago. I take 7 medications a day. They are now all generic. I am looking at a bottle right now that says
“ Manufactured in Verna Goa, India “. Another one of my medications I have been taking was just refilled and the shape of the pill and color changed ! I used to take Crestor now it is rosuvastatin ! Well your article sure gave me a lot to think about and I thank you for publishing it.
20
It must be remembered that the Bush Administration made a deal with the pharmaceuticals that Medicare could not negotiate prices and we drug users were blocked from buying outside the country. The Bush administration even stopped busloads of senior citizens coming back from Canada drug-buying trips and had their drugs taken from them. American pharmaceuticals told us we “Could not trust the quality” of the drugs in Canada, even though those, ‘cheaper, drugs were from America. President Obama was unable to remove the ‘No Negotiating’ provision because the Republicans blocked him. Trump promised to remove it, but of course didn’t. Another reason to vote Democrat.
36
@Jerry Sturdivant I'm all for voting for Democrats, but this article addresses a different issue than price negotiations. Indeed, the article indicates that the unannounced inspections were terminated in 2015 - smackdab in the middle of Obama's second term. And it's not going to do us any good to buy drugs in Canada if they're made in the same countries (India and China) that can't seem to put out an acceptable product - yes?
12
@Pryor Lawson
The Republican Congress starved the FDA to reduce those pesky and burdensome regulations and investigations. Because of Citizens United I have no confidence in the Dems until and if the people figure out that they are being conned.
6
@CH Several Democratic candidates for president have included a repeal-Citizens-United plank in their platforms. Who is doing the conning?
4
From someone who has spend months in India and China inspecting pharma plants, I can only endorse these findings. There is no reason why Americans or other generic consuming nations need to accept lower cost generics with poor or possibly unsafe products. It is time to demand a level playing field for surprise US inspections and global inspections. It is unclear how the FDA could reject this concept and still maintain that current generic products produced overseas are safe and effective. I believe this important topic deserves more spotlight attention in this Era of attention to drug costs. Tzodikov Associates, module3.com
52
@Nate Tzodiko
Eighty percent of US prescriptions are for generics. Would you know if FDA aggregates data linking adverse events to generic compounds? (Maybe via the FDA Adverse Event Reporting System?) With the worrisome quality lapses at generic manufacturing sites, it's hard not to consider these products "counterfeit" medicines.
13
Wait until the government has total control of healthcare. Along with worsening quality problems, pharma R&D will essentially end. Take away the profit motive and there’s no excess cash flow to fund new research. I strive to avoid generics when, I can until I no longer cannot.
5
@Once From Rome Oh, stop with this meme. There will ALWAYS be R&D, because companies will always need new products to sell. There is also currently an incentive to reduce quality because quality costs money. Without government controls, quality will suffer. And so will we.
22
@Once From Rome “Big pharma” spends less on in house R&D than TV marketing today. They acquire startup bio and med device companies, usually grown out of universities, in order to fill their pipeline.
It’s M&A not R&D. It’s business not chemisty.
12
Years ago most generic drugs were made in Puerto Rico. Congress took away the tax advantages for making them there and companies moved away, contributing to the decline of its economy. Bring back incentives to make generics there where the FDA can more easily monitor the situation and bring back good jobs to Puerto Rico.
196
Americans buy tens of billions of dollars in so-natural health remedies which are essentially unregulated and that they really have no idea what's in. Compared to that the issues with generics are small potatoes.
3
@Steve
If you or your loved one were given a generic prescription that your life depended on--because the branded drug is off-patent, or your insurer will not pay for the branded drug--but you learn the generic med you trusted is more harmful than therapeutic: It is contaminated, or contains no active pharmaceutical ingredient. But by now the disease has progressed. It's advanced. Your doctor contacts you: "I'm sorry , it's too late ...", No, Steve: Not "small potatoes".
9
@Steve Really? Did you read the article? Because it seems the trillion dollar 'highly regulated industry' cannot be trusted because their products are not what they say they are. And brand name is probably no different except in price because they are made in the same facilities. But sure let's ignore it and go after the supplement industry which has a record of zero deaths each yr, in comparison to the drug industry which has estimates of 50K-150K each year. Makes perfect sense......
3
“Can you trust generic drugs?” The answer is a qualified “yes,” because guarantees of safety, effectiveness and quality are only as sound as both regulator and manufacture can ensure. When factory owners cheat on crucial quality measures (whether those facilities are in India, China or the United States), all bets are off. Absent robust quality control, therapeutic outcomes suffer and the public’s trust in FDA”s oversight of generic medicines wanes. Generic drugs help reduce costs but the most expensive drug is the one that doesn’t work. The spread of sub-quality generic drugs must also serve as a warning as we enter into the era of biosimilars (FDA-approved copies of biologic medicines) that are also being manufactured around the world. FDA inspections must have a heavier global footprint and that means an appropriate budget for overseas staffing. Quality is by design and is non-negotiable. As Aristotle reminds us, “Quality is not an act. It Is a habit.
11
If this is how capitalism works (letting market forces make collective decisions and self-regulate) then why does socialism have such a bad name?
27
@Green Tea
You think that people don't cheat, lie, and steal to enrich themselves in a socialist system? Just look at how it worked out for China and Russia - more corruption than US corporations as far as I can tell.
Having the government as a independent enforcer of free market commerce seems to me to have a better chance than expecting government run enterprise police itself.
1
@Green Tea Soviets ruined it for multiple generations. Now US is ruining capitalism. Things will balance out.
2
The way things are going in this country I think we have to assume that some of these same problems are present here as well.
3
@Dan
I wouldn't forge records to enrich my companies shareholders.
If my company asked me to fake safety or emissions documents, I would quit and call the FBI. I don't look good in an orange jumpsuit.
10
As a rehabilitation case manager, I accompanied a client to a visit to a new neurologist he was seeing. This man had been suffering with seizures for years and it was time for another opinion. This new doctor was from India. She recommended he try a drug which he had never been prescribed before. However, she insisted he receive the name brand version, not the generic. Out of curiosity, I asked why. She said simply, "It's better". Now, I know why. She knew.
42
Yes, I am glad to see this being brought to the public attention.
One more angle: when the patient finally realizes that the generic version is not working well, and tries to demand to receive the name brand version....wait for it....
The insurance company then refuses to pay. So all the big companies profit (at the expense of the patient).
26
@WR This is a real issue and it happens more often than not.
The root cause of this is the FDA insisting that the Gx is bioequivalent to the Rx, even in cases where their own inspections have documented ought-right fraud as this article lays out.
Until such time that the FDA begins to acknowledge that poorly made Gx drugs do not work as intended, even if the ANDA demonstrated the manufacturer’s ability to make it properly, insurance companies will continue to do this and I am afraid they are on legal ground.
We need to fundamentally rethink our quality management system when it comes to medicines we consume,
20
@Dinesh Thakur
We need to fundamentally rethink our quality management system when it comes to medicines we ....manufacture.
3
Generic companies compete on price and rely on margins, period. Perhaps taken for granted, but generic companies wouldn’t exist unless new drugs were discovered by innovator companies. Further, while many assume new drugs are invented in an academic lab, the vast bulk of the expense of creating a drug comes from the cost of running studies and developing the means to manufacture and produce those drugs reliably. So generic manufacturers basically rely on their ability to copy what innovators have discovered, rather than developing expertise in house. When Americans focus on getting drugs on the cheap, that’s what they will get.
8
@LTJ
Americans are justified wanting "drugs on the cheap", given exorbitant drug prices. But safe, effective drugs is assumed, and unrelated to price.
5
For all the talk of generic drugs being the same as brand name, in many instances it is just not true. Some years ago there was a major recall of the generic drug metropolol, a beta blocker that many people are on. Why? The medication was the same but the inert ingredients used to bind it together in a pill were different causing different rates of absorption in the body, which is definately not what you want in an extended release drug. The generic version of the steroid eye drops Pred Forte , same thing. The same medication in a different solution. The brand version you can shake 5 or 6 times, the generic you need to shake about 20-30 times before using. Not even the doctors know this most of the time. So, not only impurities and filth, but different ingredients that make a big difference in the efficacy of the drug.
32
@T. Diaz
This is exactly true. Also, while the generic version is required to work essentially the same as the name brand, the pill coating does not need to be the same. The cheaper coating of a generic pill may not protect the active ingredients as well as the name brand and if the medication is not fresh, the active ingredients may not be effective.
4
@T. Diaz, the drug you refer to is spelt metaprolol - otherwise your observations and conclusion are on target.
2
It is obvious that the entire system is broken, all for the sake of greed and profit. The off shore manufacturing is done to widen a profit margin that is already obscene, for the "name brand" or the generics. The insurance companies, to maximize profits, refuse to pay for anything if there is a generic counter part. The "name brand" alternative is obscenely expensive so as to be unaffordable by the majority of people, so the vicious cycle is back to the generic. And the obscene price of the "name brand" is even more outrageous when it is made off shore at the same plants that sell the product in their own country at 20-50 times less than it is sold here.
Unfortunately, in a "market driven" medical industry, there is little we can do because what is the alternative, buy these medications to survive and hopefully not get a "bad batch" or not take them and suffer the consequences.
16
I wish the US government made generic versions of medications. It would keep Americans safe and save billions, if not trillions, on Medicare prescription drug costs.
36
@Caroline
Please look up the phrase "government owns means of production". Then let us know whether you still think government making pharmaceuticals is still a good idea.
@C there is nothing inherently wrong about the idea of government manufacturing generics. Fraud is fraud and corruption is corruption no matter who does it. At least with government manufacturing, we have some chance of holding them accountable.
6
In 2017, Incredible India, India's tourist organization, published a statistics indicating that 1 in 3 tourists leave India early between 2013 and 15 because it was too dirty. Dirtiness is inherent in Indian society. The thinking is that there is always someone of lower status who is supposed to clean up after you. That you would want to produce sterile drugs in that country has always been beyond me.
I have tried to help companies worldwide that had troubles with the FDA. The management style in Indian companies is one of fear. Admitting an error is almost sure to get you fired, even if it is someone else's error. Turnover of over 30 % even at health companies is not unheard of .
However, fake data, shadow information systems, shoddy investigative work to understand the cause of deviation from production processes are common all over the world, in India, China, Europe, in the US. And as was pointed out elsewhere, most branded drugs are produced in India, too, using the same API, and the same galencis, just stamped into a different pill shape.
33
@Anonymous
See Gardiner Harris' 2014 piece in the NYT: "Medicines Made in India Set Off Safety Worries".
3
I once got a weird generic of a drug I've been taking for years. It was an odd color and I noticed that I didn't recognize the name of the manufacturer. It gave me heart palpitations and other symptoms. This is a truly frightening article and I cringe when I think of the power that these overseas plants have over our population, esp our troops. Scary.
29
Many issues come to play here but I think one of the most important is the way congress has been bought off by lobbyists of the pharmaceutical companies and the pharmaceutical benefit managers, (what a misnomer). Even people who should know better, Consumer Reports, The Medical Letter, have still not faced the issue that generic drugs with a narrow therapeutic index are causing problems. They are still advocating generics without much qualification.
The physicians are just starting to get it but only individuals are speaking up. You don't hear anything from their associations and societies because most are taking big money from the companies. The New England Journal has just started publishing articles about the generic problems and to their credit they are among the first.
The Europeans seem to be doing a good job of regulating things in an ethical way but I'm afraid that ethics in medicine has sold out.
47
@Pharmguy
Agreed: Europe will block an import.
4
I have worked for name brands pharmaceuticals and generics and I can assure you, that while manufacturing is certainly not as bad in America, I have seen things that are clearly not legal. I was laid off one job, when I refused to sign off on a report that had been tampered with, I was told that they never threw anything away. That was at a reputable large company that used to manufacture in NJ. Many American manufacturing facilities have been shut down and the results are alarming. When I worked at a generic plant, Indian medications would ofter come with machine parts mixed in with tablets, but these boxes would simply disappear into the director of QA's office. I stopped taking over the counter generics from Wall-Mart and other brands. The FDA does not have enough inspectors, but the companies also have an obligation to inspect the plants they are using and while they pretend diligence during inspection, they can largely be led around the most egregious errors, when it means enormous cost savings. The generic plant I worked in, in NJ used almost exclusively illegal aliens as labor. They were supplies by a contractor, who also supplied training documents. They were paid minimum wage and kicked some of it back to the contractor for documentation and transportation. The company was making a lot of money. I have been to India and recently been to China, I highly doubt that they can come close to the quality of manufacturing in the US, but it's all been outsourced.
56
How sad that many note/agree that journalists must save us, not the FDA. We've so lost trust in so much of our government at the same time people want no cost access to the WORK of journalists.
14
Peter Baker, a federal government inspector, was the hero, not the journalist. But I agree with the sentiment that good journalism must be supported by us all.
16
@Linda Levey, I wasn't clear. I was referring to the comments where so many were asking for more coverage of this issue. When I wrote my comment, hours ago, nobody was asking for more funding/staff ,and higher taxes , for FDA.
6
@joan
And government won't save us: In 2018,
"The Congressional Budget Office (CBO) has said in a report that a bipartisan bill awaiting a vote in the senate would allow generic versions of drugs to reach the market more quickly and reduce federal spending on prescription drugs, in the United States"
3
I’m so grateful to see that someone is finally bringing attention to this!
I have a family member with Parkinson’s whose medication completely and suddenly stopped working after being switched to a new generic. I myself literally nearly died, and was very ill for an extended period of time, due to a serious medical condition that was virtually uncontrolled on a generic. Once I was switched to the name brand version, the difference was shocking. On another occasion, a generic came on the market for something I’d been taking for years. I switched, and immediately had a severe allergic reaction as soon as I took the first dose. I switched back, and was fine again. I could go on with more stories.
It’s gotten to where every new prescription feels like a game of Russian roulette.
56
Americans need lower prescription drug prices. That does not necessarily equate to switching to generic drugs. If the United States purchasers the largest share of prescription medications, we ought to be paying the lowest prices of any nation; not the highest.
We need the Department of Health and Human Services to negotiate Rx prices for all Americans. Alternatively, we could move to a National Rx Plan.
21
The author mentions that patients don't think about where or how their generics are made. That's because we have no way to do so - that information is not available when we get our prescriptions at the pharmacy and we are certainly not given a choice. This is one area in which we need to depend on the FDA to do it's job well.
13
@Larry Figdill
The US should require the manufacturers name and country of origin be on the label of the manufacturer's package. Most packages and package inserts only show the distributor, so there is no way the pharmacist can tell you where the drug was made. How can this outrageous situation be allowed? The answer is pharmaceutical companies and their lobbyists. There is big money at stake here folks.
12
The European Union has a reasonable solution to this problem. Drugs manufactured outside the EU (US, Australia, Japan, possibly excluded) must be tested at an approved laboratory in the EU before getting released into the market.
288
Same thing is happening in aviation. Not one major airline does their heavy maintenance checks in house, something that used to be common. They are now going overseas to the lowest bidder with absolutely no FAA oversight.]
Unless you're on a airplane that is less than 5 years old, it's been through one of these checks.
I have personally seen primary structural parts get signed off as airworthy when they were beyond limits, the repair would have cut into the profit. That was in a facility in Alabama, the airline that was having the work done is now part of one of the big three. Imagine what happens overseas. By the way, workers working under a repair shop do not have to be qualified or licensed aircraft technicians. Only the inspectors require a A&P license and I've seen many compromise theirs to keep their job.
40
I used to work at a tech firm that was ISO 9000 rated. I was a software lead developer and the only way they could pass the iso 9000 inspection (announced in advance) was to give me the day off.
The ISO 9000 standard had a thing about not having printed documents in the workspace and I was printing and marking up and spreading on the floor a thousand or so pages a day, so it wasn’t like there were buckets of urine scattered about, but pre announced inspections are a joke.
32
Used to be because of tax breaks there were quite a few pharmaceutical manufacturers in Puerto Rico. The tax break ran out and the drug companies packed up and left.
It would seem that enticing companies back to PR to make drugs would be a win-win solution. The talent is there still, if they haven't left because the jobs aren't.
42
When I first became a pharmacist in 2003 , I rarely saw generics manufactured outside the us or western world . Now I believe the opposite is true hence the increase in recalls .
38
@V N Rajan. I disagree. As someone who’s worked with a variety of India- and China-based outsourcing firms, I can confirm that in a very high percentage of cases, venality and incompetence on the part of the supplier company take the day. An example: I sent a sizeable corporate application of Perl code, which was well-written and maintainable, to a well-known outsourcer to recode in Python (it’s faster) with instructions regarding the use of specific variables and modules to preserve maintainability and backwards compatibility. After a very disappointing first module review - it simply didn’t work - I initiated a daily code review, which only highlighted The issues with of the supplier’s work processes. They would openly lie about having completed work and having observed the coding practices for which we were paying.
We terminated the contract and went with a US/Europe-based consulting firm and received vastly better results. This is not due to worker incompetence - some of the Indian supplier’s staff were outstanding - but rather to a culture which was about producing just enough to qualify for the work period’s payment. It was venal and corrupt, and when we confronted the supplier executives, they made excuses, blamed their developers, and failed to take responsibility for a bleed-the-customer ethic.
8
Took an OTC brand name anti GERD medication made in Sweden and it worked perfectly. Then my physician wrote a script for generic and after two weeks my GERD was driving me nuts. Switched to name brand and all was well. Generic made in India. I wonder what was in it. Just one experience but a bit unsettling.
29
A generic has to be 60 to 80 per cent bio available or be absorbed into the blood to be considered equivalent to a brand at least from what I remember I still dont think that’s a good standard
8
@Fawad Malik What you say is true, but for drugs that are classified as narrow therpeutic index drugs, like those for pain medication, the variability has to be much tighter. The FDA has revised the way it looks at bioavailability of these drugs.
Having said that, the problem IMHO is not the acceptable range, but batch-to-batch variation. One batch may be just fine with 15% bioavailability compared to the innovator, while another batch from the same manufacturer may have much high variability, as much as 30-35%.
7
That’s very high
2
Generic medicine must copy the total formula not just what is conceived to be the active ingredient. The chemical compounding between the active ingredient and the compounds necessary to complete the product is what we should be getting in the generic formula not just the active ingredient.
Generic medicines must always have the manufacturers name on the prescription as it would force them to be more compliant as far as the purity of the product is concerned. If we allow unscrupulous manufacturers hide behind not having exposure because their names do not appear on the label on prescription they would continue to do things that may be not appropriate for our prescriptions. Country of origin must also be clearly labeled on every prescription dispensed in the Country.
These few proposals may help us avoid drug manufacturers operating out of garages and basements.
16
@Wizarat That is just not true for many generic drugs though. While the active ingredient is the same, the inert ingredients may not be. Case in point, generic versions of Pred Forte eye drops.
3
And, this article is just the tip of the tip of iceberg regarding India generic manufacturers. Their only motive is profit and they can profit on a penny while regulated markets require considerably more in wholesale prices to achieve a modest profit. The entry of India and China into the API (active pharmaceutical ingredient) market and the generic finished dose market is nothing less than predatory. In the past, European cartels controlled both but did so with an emphasis on quality, consistency, and high value. They are nearly expunged and overrun by the low cost, high volume India and China manufacturers. The European model placed a high cost of entry into the market eliminating potential competition and controlling supply. Supply is no longer controlled and cost has plummeted along with pricing. Also plummeted are quality and consistency. It’s as though an artist were overrun by a thousand flawed clones.
The entire FDA process of generic drug approvals needs to be redrawn to include systemic quality controls (batch records, quality testing, packaging protocols, computer system validation), ability to consistently supply, and packaging/shipping controls and reporting.
I’ve seen brand product markets drop by 99% upon approval of more than 15 generic competitors some of whom had nearly zero ability to supply even 5% of the US market. The major US buyers, CVS, Walgreens, Econdisc, McKesson, ABC, Cardinal, feed the beast with pricing algorithms based on approval tallies.
29
@Schimsa The fundamental disconnect here is how the US FDA assesses quality. Quality Management System in the US is based on a honor system, we seldom test samples of marketed products. We expect these companies to honestly tell the FDA how they comply with the regulations. It is for this reason, most inspections are an exercise in review of documents, not testing of products.
Unfortunately, this doesnt lend itself well to the culture in India. When a completely different standard (more relaxed than what the US FDA demands) applies for the local market, expecting people to change their behavior just because they are making a batch for the US market is a fool’s errand. Five years of inspection metrics post the Ranbaxy case tell us that clearly. We need to fundamentally rethink our quality management systems; the current model is simply not working
43
@Dinesh Thakur
I agree on all points and will only add that the retained sample testing done by manufacturers with voluntary reporting of out of spec results relies strongly on the corporate culture of each company and facility. Management, regardless of geography, plays a key role in directing a culture of compliance. I’ve worked for companies whose Management made me proud to be a part of that company as well as having worked, briefly, for others whose culture and practice made me feel shame. In working for a company based in India I was constantly perplexed by the disregard and disrespect for regulatory requirements across the hierarchy. Another US company I worked for amazed me at how scrupulous employees up and down the hierarchy took quality and safety as the most important part of their responsibilities. It starts at the top and flows to each manager and from there to each employee. While with the India based company it was quickly discernible that the problems were cultural not personal. It is important to have your expert voice address this issue as often as necessary.
10
The problem here is that a major for the move of the Pharma production of active ingredients (almost completely) and manufacturing of the finished forms out of the U.S. (besides labor and environmental costs) was the high price of "having to be honest" when you can face an unannounced inspection any day. FDA when approving the generic applications doesn't differentiate based on the producer's location, only on the status of the quality systems as they are presented. So, a cheating company will always win business when the buyer (drug chain or PBM) is looking for the lowest price bidder.
Generic drugs (mostly) are meaningfully cheaper stateside than in Europe, and many fewer generic players are allowed for a particular drug there. This allows the companies to make profit AND not cut corners. We just need to swallow hard and agree that the monthly supply of your blood pressure meds should cost not $5 but maybe $25 - and make PBMs liable for sourcing from the subpar producers.
18
An absurd yet feasible proposal - Nationalize Big Pharma - or at least set up (under FDA presumably) a US-based govt-administered production facility for generic meds. Because of campaign-funding-addicted legislatures this will not happen in my lifetime. But soon as accomplished a practical and needful nation will say - Why, of course, how sensible of us to provide ourselves this basic and essential service. Free from the intervention of price-inflating profit-driven private vulture capitalists in the health economies of Americans.
16
What I don't understand is: how expensive can it be to manufacture generics, such that there's any real savings in having it outsourced overseas? Is lisinopril that much harder to make than aspirin, once the patent has expired? I assume most of the manufacturing is automated anyway, so it can't be very labor-intensive. They must be able to crank out millions of pills in, say, Kentucky, for not much more than it would cost to import them from halfway around the world. I'd pay the extra penny or two a pill to know that it was manufactured somewhere closer to home, and under more FDA scrutiny.
116
Aspirin isn't made in the United States.
2
@Jack Daw Here is some good analysis you may be interested in:
https://pharmachemicalscoatings.blogspot.com/2019/04/impact-of-regulations-manufacturing-and.html
2
You have no idea how long I’ve longed for this expose! I worked in generics from 2001-2011 for foreign owned US manufacturers and for one India manufacturer. The difference is night and day. US based manufacturers have US citizens overseeing processes, protocols, and regulatory requirements. There are permanently assigned FDA parking spaces in front of their buildings with the assumption that FDA inspectors may arrive at anytime, 365 days/yr. The plants are operated asked on this assumption of imminent inspection so that when FDA inspectors do arrive, it’s business as usual, though perhaps a bit more tense.
The Indian firm I worked for was absolutely the opposite. They scheduled inspections ahead of time, slowed production prior to and during inspection. Records were created specifically for the inspection, and failed batches removed from records. In one instance, they tried to hide a quality lab not approved by FDA, only to have it uncovered. Their excuses were as lame as their protocols and internal process discipline. Buckets used for cleaning mops were also used for finished oral dose product. Manufactured product using contaminated water was released for US export based on a third party eating with a wink and a nod. 90 batch failures on a product did not haunt production or become part of saved records. The absence of running water in sterile area restrooms was common. I left and cringed. Sorry to report, there are few US manufacturers left.
356
And why are there so few American manufacturers left?
GREED!
15
@Schimsa, to whom did you report your findings and concerns? Leaving and cringing solve nothing if no further action taken.
11
@Schimsa
I hear you: I work in Pharma manufacturing, and the quality lapses at Indian manufacturing sites defy belief. Will it take a significant adverse event to end the manufacturing sham? (When 80% of US scrips are for generics, is AE reporting quashed?)
25
You'll find the same pre-announcement audit issue with The Joint Commission - JCAHO which accredits hospitals here in the United States.
Hospitals know when the auditors are coming, put staff and nurses on high alert, and everyone breathes a sigh of relief when it's done with for another year.
44
Generic drug manufacturing has been off-shored to save pennies at the cost of both quality and national security. A country that cannot manufacture its own quality drugs is vulnerable.
196
No one can disagree that FDA must inspect drug manufacturing facilities, whether they are in U.S. or anywhere else. But the last part about "Made in America" label is a polished way of tapping into nationalist and protectionist temperament. FDA must inspect manufacturing plants unannounced anywhere. And similarly, other countries must be able to inspect local firms unannounced. With one of the weakest regulations in the developed world, I won't be surprised if Scandinavian countries feel the same way about our manufacturing plants.
25
@Jay
No need for that. Just inspect the Imports.
2
@Jay
No, no: In the context of this article, Jay, "Made in America" is a plea for stronger safeguards--no dog whistle.
3
I’m taking a generic hypertension drug called losartan and have received at least 6 recall letters from my pharmacy for numerous lots of impure batches of this drug. The generic is made in India by Torrent pharmaceuticals. I’ve had to have numerous Losartan prescriptions replaced but always with the same Indian generic. Yet CVS keeps buying the tainted generic from the same manufacturer. It’s disgraceful that this plant is allowed to continue its operations and that US companies continue to keep them in business.
367
@Angela
Ditch CVS! Find a local, non-chain pharmacy where you can talk to an actual human an he or she can tell you the source of the drug. That's what I did when I had problems with different manufacturers of a drug I take.
Another reason to support local businesses!
23
@Angela I'm also taking this med I have only gotten the letter 2 times, but both times Wal greens told me they hadn't received the contaminated batch not to worry, but I'll forever worry now so I'm going to try and get switched asap!
11
@Angela CVS is a parasitic corporation, why do you keep going there if they insist on buying from a incompetent supplier. My bet is CVS is getting a great deal at your expense.
14
The simplest solution is to ban generics manufactured outside the United States, Canada, the United Kingdom, Australia, northwest Europe, or greater Scandanavia.
Anywhere else, ethics, enforcement, and accountability are entirely absent, all the time, everywhere.
We have had a handful of bad actors here in the US, their actions detected after the fact, but at least they are punished afterward - the contaminated drugs from Massachusetts come to mind.
But in China, India, etc., it is a way of life.
236
I was taking a generic drug with a co-payment of only $2.00 for 90 tablets. An uppity doctor I went to see for a second opinion changed by drug for a brand name which cost me $80.00 for 90. I ended up hospitalized with pulmonary hypertension as a result of the brand name drug. The day I visited that doctor for the first time I saw two people coming out of his office with what was probably a package of drugs they want the doctor to give his patients. I presume they were big pharma representative. I do trust generic drugs.
10
@Tonjo I am sorry for your personal experience. I hope you read some of the further comments below. In one—my response to Candlewick, below—I offer a case that gave this household reason not to fully trust the system that chooses providers of generic drugs. Granted, my one is no more numerous than your one example, but it might give pause.
4
@Prof B Thank your for your comment. It is now two years that I am back taking the generic beta blocker Atenolo. Perhap I am very fortunate that my insurance does not prohibit me from taking brand name drugs. It was Hydrazaline a generic drug that opened my arteries for the better flowing of blood that was decreased from the use of the costly brand name drug I was prescribed when there was no necessity to do that because my blood pressure numbers were fine.
1
Why is it ok for the FDA to decide who gets to sell us a drug and at the same time, be the arbiter of which of these substandard drugs remain on the market? If our aviation safety is vested in FAA which qualifies the equipment and pilots for safety and the NSTB which steps in when things go wrong and figures out what to do so that it doesn’t happen again, ever wonder why both of these functions are vested in the FDA when it comes to public health? Why does the agency which approves these manufacturers to sell into the US market also gets to decide whether to suspend wrongdoers from making money selling substandard drugs to us I wonder?
Also IMHO, @Fiorella is spot-on. The agency often walks a fine line between $4 dollar refills and drugs of substandard quality and often tips is scales in favor of keeping drugs of questionable quality on the market for the fear of creating a panic with shortages. The time has come for us to think constructively about how low a co-pay is too low for good quality.
14
As long as they are not manufactured in China we are probably going to be alright...
3
@Don Juan
If you read the article completely, India was a huge culprit with inferior manufacturing. From India, the FDA inspector then went to China.
2
@Don Juan You didn’t read the article? There were a lot of problems in India, as well.
1
Timing of this article is interesting. Wilbur Ross was just in India complaining about drug patents and IP. IOW, Indians who cant afford Big Pharma prices, should pay up or die.
The overseas generic problem can be fixed overnight. Big Pharma reduces prices.
5
@Cosby How specifically do you propose to solve this complex socioeconomic problem? U.S drug prices will inevitably be relatively high, globally. As one of the most affluent of nations, it is American ability to pay, and not that of the poorest of nations, that drives the costly innovation that brings new drugs and delivery systems to market.
If one assumes you are not suggesting tying price to the broadest of standards of affordability, to what index do you propose drug prices be tied? Is the solution you propose a price restraint system as in place in France, Germany, Sweden, and the United Kingdom, with attendant levels of taxation to offset healthcare costs for its citizens (see below for relevant data for Sweden}? These countries manage on the order of 1 in 4 new drug applications, but account for few of the most used drugs on market.
Perhaps it is constraint according to the International Pricing Index, as used by the Czech Republic, Finland, Greece, Portugal, and Slovakia—players absent from leadership in new drug discovery, but which offer government-run socialized health care, though often from underperforming economies (Finland the clear exception). Or is it a more highly controlled economy and process you propose, such as in use in Cuba, North Korea, or the PRC?
I.e., what specific stick do you plan to wield to get "Big Pharma to reduc[e] prices", and into what shape will you beat it? Hard questions demand deep, thoughtful, and careful answers.
8
America makes almost none of its own antibiotics anymore? Eighty percent of the ingredients for drugs are made in China and India?
Has anyone even given the slightest thought to what kind of security threat to the health and safety of all Americans this constitutes, but especially to our troops, in wartime? Has anyone noticed that the Chinese are already making an undeclared war on us?
Where do we think our antibiotics and other medications will come from if the international situation really heats up? Or that we will get remotely safe ones, if we get any at all?
Oh, yes, battlefield medicine without antibiotics...just like during the Civil War.
Miryam is right. The wealthy don't want universal health care because they would have to...pay taxes to make it more affordable for the rest of us, when they can simply write a check for their own needs. Hey, if I could do that, I would, too. That, and a little bargaining with the drug companies over prices, currently illegal under US law (thank you, President GW Bush), would go a long way toward making the situation better.
167
@JB Please see the response given to Miryam.
1
@JB See my reply to Miryam.
Why have not the manufacturers of the branded pharmaceuticals promote disclose the fraudulent practices of the companies described here. And why aren't the patients getting sick and dying from such a cascade of contaminated drugs?
Apparently this kind of corrupt inspection has been going on for decades, spanning multiple administrations. Could it be that the purity regulations a too severe, since there would be negative health consequences if contamination were as bad as described.
If accurate, this deserves a featured multipart front page expose article.
9
@Call Me Al Unfortunately, the dirty secret even among branded drug manufacturers is that they subcontract their own product for white label marketing to these CMOs (contract manufacturing organizations) located overseas purely for economic reasons. Have you noticed that your package insert (the piece of paper that your pharmacist gives you along with your pills) has the name of the company which is authorized to sell the drug you just got, bit it doesnt tell you where it is made? Ever wonder why?
To the other question you asked, why aren’t we seeing more patients getting affected; my data says there are. We are just not looking hard enough. Nine out of ten times when a patient goes back to the doctor to complain about his prescription not working, it is much easier for the doctor to switch the formulary than to call and report it to the FDA. Most HC providers aren’t even aware of the fact that this is a real problem, thanks to the great confidence we have in what FDA says.
18
@Call Me Al I literally almost did die from a generic version of one of my medications, and had a violent allergic reaction to another. I have had absolutely no problem with the name brand versions of either. My partner and I both have had so many severe issues with our generic drugs over the years, it’s downright terrifying.
4
@Call Me Al Every case is different; there is no general answer—but, I am sorry, NO, it is generally not the case that purity requirements are too severe. I say this because the safety of the drug being marketed is only ensured to the extent to which it is that agent, and that agent only, that is provided.
(If you want to understand our need to avoid even "just a smidge" of something other than the drug, skim articles you see after searching "nitrosamine impurity losartan FDA". Or seek out a medicinal chemist, and review, e.g., the Extremely Hazardous Chemicals list of 40 CFR Part 355 Appendix A (which can be found via search, online)—for things on that list that might be used in the drug synthetic chemistry armamentarium, or that might be produced inadvertently in a poorly controlled drug synthesis chemical process. Ask them—and use your own imagination—to consider the implications of the fact that these are the "known unknowns", and so only a part of the potential problem.)
Otherwise, note, risk analysis includes consideration of severe outcomes (i.e., toxicity leading to death), even it is of relatively low probability. And I do not think we would want it any other way.
You know what they say, you often get pretty much what you pay for and if you're paying pennies for a generic there is a reason for that. It is also often claimed that the high cost of manufacturing in the US is due to regulatory issues, so it should not be a surprise that off-shore manufacturing of cheap drugs is short on regulatory compliance.
One thing I am curious about is drug quality assays made post manufacturing, done here in the US on drugs imported from overseas. Despite the bad record keeping by some off-shore companies, how bad is the product itself? The FDA must be doing some of that testing also.
9
@Scott Werden
FDA does very minimal testing of post approval generic drugs unless there are patient reports of side effects or lack of efficacy.
12
@Schimsa
This is what I was coming here to ask / recommend. It would be better if we had a more robust system of both plant inspections and random sampling from various parts of the supply chain. Your randomly selected bottle of meds doesn't check out, and you're shut down from exporting to the US until you can both explain and rectify the situation. Wholesaler and retailer could also be fined for each instance, which would push them them to monitor their suppliers. Oh, and publish the list of failed tests, manufacturers, and who agreed to import from them.
5
@Schimsa
But how readily can lack of efficacy or side effect be isolated to the generic compound, and not caused by a concomitant factor? (Or, why do I suspect investigative analysis might be ...lax?)
1
There are many very good Replies to this article, and many that are poorly informed. Unfortunately—in accord with general results on the limited validity of popularity metrics in determining the factual reliability of online content—the number of Recommends to the Replies that appear in following is a poor metric to determine if the content in the Reply is evidence-based (in this respondent's better-than-average informed view).
My further views appear in response to specific replies; these are unfortunately, for reasons of time and space, limited to correctives to particular Replies whose basis in evidence is, in my view, most suspect as of this timestamp.
4
As a practicing nurse for over twenty-five years, I consider this issue of the flooding of our health care markets with inferior and even dangerously manufactured generics to be perhaps one the dirtiest big secrets of any in the current US medical system mess. I will also say this. This problem goes back even farther than 2014. I realized something was terribly wrong back in the late nineties when I couldn't initially figure out why one of my patients diuretics had mysteriously and apparently began not working the way it had while she had been hospitalized. Her CHF edema was not being properly kept at bay. So, I did some behind the scenes sleuthing on my own and came to find this. In the hospital she had been ordered Lasix. (Brand name). But once home, the pharmacy had given her furosemide (Generic). Once she was given the brand name all was back to normal.
I blame those at the FDA who loosen the rules according to whomever their master politicians are at any one time. I also understand why the wealthy don't want Universal health care. They don't want everyone to have the same level of care they do. A real shame.
227
@Miryam The anecdotal evidence of healthcare providers is important because your training adds substance to your assessment of the case at hand, and because aggregation of such gives us a growing "database" to appraise the severity of the problem (which in turn can help force policy change to address it). While the situation has improved since the 90s, Ms Eban makes clear that broad commitment to drug safety as first principle is not universal among generic manufactuers.
However, is it helpful to deny the complexity of the issues involved? Arguably, the FDA and the affluent—your Reply, beginning with "I blame..."—are less root cause of the predicament than those who instruct their workers to keep testing an API until passing tests are achieved, those ignoring cleanliness or storage requirements then hoping for the best, etc.—or indeed, those who poorly craft legislation allowing such nefarious players in the game, or poorly fund or create working boundaries that stymie those charged with keeping such players from hurting people. Your past patient's medical condition required all your training, and then some, to bring best practices to her treatment. In the same way, a variety of skills (variety of individuals, of disciplines) will be needed to fully solve the problem of providing safe and efficacious pharmaceutics at affordable prices in global socioeconomies. (The U.S. is a challenging problem; the aspects and nuaces of the global situation only add to the challenge.)
5
@Miryam
Your posts is spot on. The biggest driver of this poor quality is unrestrained lobbying for profits on behalf of the manufacturers and distributors of these drugs. Pharmaguy posted that many generics used to be manufactured in the USA, but are now outsourced to other countries. Out of sight-out of mind. There may many reasons in the manufacturing process why a drug is bad, but ultimately the profit motif is driving the production of lower priced and and poorer quality drugs. Scott Gottlieb was the director of the FDA. He is a fellow at the American Enterprise Institute and even he was criticised by conservatives for trying to curb young vaping by young people. He resigned. It is going to keep getting worse until we get people who believe in regulation in place.
11
@Prof B 'However, is it helpful to deny the complexity of the issues involved?'
Prof B- Denying that it is our politicians who have purposely sold out our once stellar and cost efficient generic drug system to their profit seeking corporate buddies who off shore to a hygiene deficient place such as India is known for, seems below your stated intel level. Allowing import of inferior generics, first, without US batch testing as they arrive, but worse, giving false sense of security by invoking this idea that we 'go there to spot check in India' is pretty much tantamount to at the least incompetence, at the worst, purposeful negligence. Not complex. You just order generic manufacture back stateside.
14
How many of the brand name drugs are made in the same overseas plants as the generics?
33
@Cassandra
Almost none. The brands may enter a generic market but they use the same production line for both brand and generic. They just want to maintain volume.
3
@Cassandra None, of which I am aware.
As a practicing nurse for over twenty-five years, I consider this issue of the flooding of our health care markets with inferior and even dangerously manufactured generics to be perhaps one the dirtiest big secrets of any in the current US medical system mess.
I will also say this. This problem goes back even farther than 2014. I realized something was terribly wrong back in the late nineties when I couldn't initially figure out why one of my patients diuretics had mysteriously and apparently began not working the way it had while she had been hospitalized. Her CHF edema was not being properly kept at bay. So, I did some behind the scenes sleuthing on my own and came to find this. In the hospital she had been ordered Lasix. (Brand name). But once home, the pharmacy had given her furosemide (Generic). Once she was given the brand name all was back to normal.
I blame those at the FDA who loosen the rules according to whomever their master politicians are at any one time. I also understand why the wealthy don't want Universal health care. They don't want everyone to have the same level of care they do. A real shame.
12
Yes, we need better policing of the dosage label claims and purity of medication being imported into this country. Importation may need to be limited to bulk containers, from which samples are extracted at random for analysis by officially licensed and inspected quality control labs here before imported lots are released from quarantine for re-packaging here by captive companies, with American sounding names, who now hide their true identity by using the legend "distributed by." That leads consumers as well as dispensing pharmacists to believe that these are products subjected to FDA-mamdated quality control. That problem, by the way, is not limted to generics. Some brand name products from that origin also are on our pharmacy shelves. Check, as I have, and you will discover both.
13
Has it occurred to no one that the very reason India and China are so "competitive" is that corner-cutting is built into the cost-calculating? After all, making drugs is capital intensive, not labor intensive. Manufacturing in China and India should never have appeared much cheaper unless less impeccable conditions were baked into the numbers. As the FDA's discard of unannounced inspections suggests is indeed the case; the 2015 change suggests that the FDA knows it can't have both unannounced inspections and $4 per month prescription refills for a desperate American populationl.
80
Several years ago my pharm filled a prescription of pills. When I opened the bottle I found that they resembled a pill i was taking for another ailment. There were no markings on the new pill. It was identical in color, white, and size. No pills are allowed to be identical, they must be a different size, color, or have different markings. This is mandated by the FDA who publishes a catalog of the pills and their marking so that it is not duplicated. Returned the pills to the pharm and requested different pill which was identifiable. Never did find out how this unidentified pill got to market. probably because it was cheaper for the pharmacy.
11
@impegleg -- OMG, that was scary. These pills could have killed you!
There's a medication I take almost every day. It used to break in half relatively easily; now at least half of it disintegrates into powder when divided.
The other med, for once in awhile flare ups, used to be a normal-looking pill. White and fairly large. Now it's still large, but is either a dark green color or black (can't tell which). Though it may sound weird, it is the first time very I may not take the medication because it looks unhealthy.
3
@Nancy G
The different colors and textures indicate the same-name generic drug was produced by different manufacturers. The pharmacy benefit manager, who orders a shipment based on price, supplies the contracted pharmacies. You can find the manufacturer's name in small print under your physician's name, date filled, etc. If you notice your prescription isn't working as usual, you can address the problem with your pharmacist, who can confirm whether the manufacturer was changed, and replace the Rx.
1
People who've decided they've had enough of their pile of prescribed synthetic drugs with the long list of side-effects, often decided to just throw them all out, and say they now feel much better.
Apparently the MDs don't know much about them since they're always experimenting when they first give you one, then another and another to see what might work.
So you have to wonder if most people really need pharmaceuticals at all since they never experience a curative effect regardless of how long they take them. Shouldn't there be some benefit from all those side effects?
Not to mention they kill over 100,000 people every year according to AMA statistics, and research by Harvard's Safra Institute has found that they rarely have any positive effect at all beyond that of a placebo.
Are there non-biased studies that positively show a solid benefit from taking all these pills for each condition compared to not taking them? Or do we just assume that? From what I've heard there is no benefit except in a few minor cases, and mostly very negative outcomes including an early death.
Pharmaceuticals may be doing far more harm than good - should we question Big Pharma, is that allowed?
Of course they definitely are massive money makers for the drug industry (the most profitable industry group), so there is that benefit.
But even with that benefit, you have to wonder if we need really them.
2
@Fourteen14 "Are there non-biased studies that positively show a solid benefit from taking all these pills for each condition compared to not taking them? "
Yes, these are called clinical trials. They require double-blinded administration of candidate drugs so that even the clinicians themselves do not know if they are giving the new drug or a current drug (or if appropriate, a placebo) - the vials are coded. The data is analyzed by third-party contractors who are paid a flat fee and thus have no financial interest in the outcome. The data is reviewed by the FDA. Most of the drugs that go into clinical trials are not approved.
These are standards to which alternative treatments or "natural" remedies are never subjected to.
21
@Fourteen14... Please see my response to Candlewick, below, regarding the difference in the roles played by those discovering/developing drugs (who study N=large), and healthcare providers, whose responsibility is not a studied large population, but rather an individual (N=1). [This is in response to the confusion you express in your paragraph 2.]
Otherwise the breadth of skepticism you convey is beyond the scope of a reply fitting in this space—but should be remediated if you make along appointment with a well-trained physician or nurse that has been schooled and is up-to-date with their training in evidence-based medicine.
Regardless, I hope that you can—indeed that we all could—live a long life without need of any medical intervention involving a pharmaceutical. However hopeful we might be, the evidence to support that hope is sparing, to say the least. [Lower respiratory infections and tuberculosis are the 4th and 10th most prevalent causes of death globally, and for the long, hard slog to develop chemotherapeutic interventions in these, I for one am grateful—if not for the same work toward helping with cardiopulmonary diseases (occupying places 1-3), types of cancer that are in place 6, and diabetes, which is in place 7.]
4
@Prof B
Skepticism is well warranted since our so-called "healthcare system" is ranked 70th in the world, and kills over 250,000 people per year with medical errors (including pharmaceuticals).
The "evidence-based" (so-called) studies - gold standard RCT and placebo-controlled, funded by Big Pharma to push their blockbuster drugs, and waved on through Phase 3 by paid-off FDA regulators - often result in drugs that use the People as guinea pigs, as with Vioxx (60,000 deaths before being pulled).
The question remains: Show me an unbiased, non-industry (non-cherry-picked) study with proper design and cohort that shows that pharmaceuticals, for each given disease, have a positive benefit materially beyond the outcomes of that disease in it's natural progression - compared to no pharmaceutical intervention. No need to adjust for side-effects.
You might want to read Harvard's Safra Institute research first.
5
This article is long overdue! Only a few years ago I went on a date with a man who worked at the FDA. He told me then, at the bar, about the FDA's visits to India and how the Indian pharmaceutical company was seen shredding documents. Yet generic is what my insurance covers. Perhaps some of my generics are actually tainted. That would explain why I've been playing prescription roulette.
103
Only ten years ago the majority of generics were made in pharmaceutical plants in New Jersey, the Midwest, and California. But when executives from these companies realized they could reduce their costs and increase profits dramatically they shipped their machinery east. Pharmaceutical production has dropped to a fraction of what it used to be.
it was rare for a plant in the US to be shut down years ago but now we have a very scary problem here. We are paying high prices for substandard drugs and very little hs been said about it. Thanks for publishing this information. Now its time to do something about it
447
@Pharmguy
Essentially 100% of our brand-name pharmaceuticals are now derived from raw materials synthesized and shipped from China.
When "manufactured here" they are just encapsulated and packaged and distributed.
Of course they go through GMP quality control before, during, and after "manufacturing". Supplements are the same - everything is from China.
Chinese drug manufacturers do a very good job - high quality (or else their product would be rejected) and cheap.
The previous contamination problems (often due to management's corruption) seem to have been fixed.
2
@Pharmguy: And yet, you can bet that nothing will be done - not by the FDA, and certainly not under this administration!
America can do things well & do them correctly ... but then greed overtook all other considerations.
Now the USA is, pharmaceutically speaking, a third-world country - with many people being essentially "forced" to take generics (by their insurance providers or by their own finances).
25
Maybe one of the reasons the pharmaceutical companies moved their equipment abroad was to avoid all that " laborious testing".
19
. . . moreover, generally speaking, the generic drug manufacturers are immune from liability for harm their drugs cause (https://www.healthlawadvisor.com/2018/03/30/recent-state-court-decisions-and-fda-inaction-leave-brand-name-manufacturers-uncertain-about-liability-for-updating-safety-labeling-the-impact-of-the-sameness-standard/)--brand name drugs are usually more reliable. Generic and brand drugs are not the same--I know this from my own experience (and my doctor's).
Yet in California, pharmacists are now REQUIRED to fill prescriptions with the generic if insurance is used to pay for it, regardless of doctor or patient preference for the brand. Paying for the brand out of pocket is allowed. The result: given the careless (even willfully negligent as tis article points out) practices of some overseas manufacturers and the unreliability of the FDA's inspection process, the consumer cannot count on the quality of a generic. And in California anyway, a consumer cannot limit the economic consequences of opting for the brand by using insurance (which, oh yeah, the consumer is paying for) to lessen the economic hit with some insurance co-pay. Consumers lose in every which way and have no recourse.
58
Governments are supposed to use regulations to stop capitalism from causing a race to the bottom. Since that system has obviously become corrupted, it's time that society re-evaluate who we want running the show. Until we do, things like this will continue to happen, over and over again.
74
The question posed; "But can they trust them?" Most Americans have no choice but to trust generic medicine.
Medication I've taken for a chronic condition for a dozen years was initially priced at $3.00 per one month supply and $30.00 for generic ( 2010) under my health insurance plan. The price went up to $5.00 for generic and $50.00 and continued to increase.
Now retired, it costs pennies for generic yet find the "Usual and Customary" price for the generic is listed at one pharmacy at $125 and another pharmacy's retail price for the same generic is listed at $149.50. This is an old medication with multiple off-label uses. Of course it is manufactured by one of the largest Indian pharmaceutical companies and the U.S. is one of its biggest customers; quality control has been a major problem.
Do I go bankrupt at $200 each month for the privilege of purchasing the Brand-name or take my chances on the generic? My wallet says go with generic.
18
@Candlewick I greatly sympathise with the cost issue you describe. In our household we regularly (i) begin new treatment with a name-brand drug, and (ii) move to generic only after its efficacy/safety are established for the one of us in question (N=1). [Drug characteristics are established in populations (N=large); it is one's testing with one's GP that establishes where an individual's, N=1 response lies on the population distributions of efficacy/safety data.)
Then, critically, (iii) we order the generic before running short on the name-brand, giving time to reject generic manufacturer (mfr) issues revealed by a duly diligent review of reports on that mfr's facilites/practices (see google search given in reply to "Our Road to Hatred", below). (iv) If such diligent reviews do not provide a generic mfr that we trust, we return to the name-brand drug mfr and seek cost-reduction programs, directly and via our insurers. E.g., we recently rejected our pharmacy-supplied generic amlodipine besylate given the generic mfr's ongoing history of FDA warnings—from our professional perspective, warnings for egregious manufacturing and testing practices—instead, availing ourselves of a Pfizer year-long "coupon" program to make their Norvasc affordable.
Bottom line, unless one wishes to be an unwitting participant in an undesigned clinical study of the effects of uncharacterised impurities in a less-than-identical generic—care must be taken that any switch is truly "apples to apples".
11
@Candlewick There is another option, but the FDA forbids it. You could try to order from a Canadian pharmacy. Such pharmacies can be searched for online.
I believe that if you are looking for a commonly prescribed drug they will give you several options, such as brand-name made in USA, made in Ireland, or made in Turkey. Generic from Israel, India, China (yes, they do make generics), Taiwan . . .
You'll have to pay with your own money of course.
The real question is why US pharmacies can't or won't give you this information, and why they keep changing what they stock. Is it just money, or is it quality feedback?
There really are differences in effectiveness even between drugs with the same active ingredients. Inert ingredients aren't always inert, and can cause the active ingredient to fail, or reactions of their own. I've experienced this personally, and been cautioned by a vet when being given a prescription for my dog. 'Use pharmacy A because they dispense X with better results in my experience than Y which B dispenses a different formulation.'
2
Quality costs money: If we want highest quality assurance and stringent monitoring, proces for generic will go up (somewhat).
Another unwelcome side effect of relying too much on the cheapest generic products out there: Drugs can become unavailable due to problems at the production plant - some drugs are manufactured at only a single plant. A problem at the plant serious enough to stop production for a few months means that patients won’t have access which for Live-threatening conditions (or natcotics) can be detrimental.
Time to bring the quality aspect back into focus, and to consider having production at least in part not just in China, India, or other low-cost countires but also in the US and in Europe, even if this means prices will icnrease some.
40
@LL Sometimes it seems, to my suspicious mind, that plant closures by the FDA are engineered by the manufacturers to cause a shortage. Total profit rises when there's a shortage. (Just like OPEC- if you should coordinate the inspection failures all suppliers win.)
The most recent examples reported in US newspapers have been insulin, and saline solution.
2
@Richard Simnett
The ISPE has a good drug shortages initiative: https://ispe.org/initiatives/drug-shortages
1
It's common for those engaged in performing quality audits of Nursing Homes to just show up....unannounced. There is a window during which the auditors can be expected, but that is usually a 3 month window. I hate to say it, but I suspect that money may be exchanged for regulatory accommodation. Perhaps audits should be done of the FDA folks who make these potentially harmful. What was it that former President Reagan once said? "Trust, but verify".
20
@Tom Chapman Quality standards and supervisory procedures are indeed in place in the agency performing the visits to generic manufacturers overseas, so your proposal to perform "audits... of the FDA folks" seems poorly based. And the sad reality is that even with the announced/unannounced question still being debated, the FDA regularly reports findings for generic manufacturers from their announced inspections (see proposed google search given in reply to "Our Road to Hatred", below). Finally, in keeping with principles of fairplay and common prohibitions of "bearing false witness" [false accusation], is it not better to hold on suspicions of corruption in the FDA's manufacturing review process until the hard investigative work has been done that might find against or for your statement?
1
@Tom Chapman
There is no better business ROI than a regulator in your pocket.
1
Unfortunately it is highly likely that the name brand drug is being manufactured on the next machine in the same plant. Unfettered capitalism has no conscience and they now own the government overseers as well.
210
@David McLarty Your statement is simply false. It is all but impossible that the non-generic is being manufactured on a "next machine". If you can substantiate otherwise, please do so, from reliable sources. But do not propose as factual, things that are little more than poorly informed opinions.
6
I hope this article lands on the front page. As an MD, generics have indeed been very helpful to my patients, myself, and my family but I and colleagues have all experienced episodes where a switch of manufacturers or from brand to generic meant that a drug no longer worked for a patient. Switch back and bingo! It's fine again.
Like other governmental agencies - like the IRS -- the FDA needs more funding independent of the pharma companies (generic or brand, domestic or abroad, etc.) to do the job they are tasked with -- protecting the public from dangerous drugs and medical devices.
463
@ms
Isn't that the MDs' job - to protect the public from dangerous drug and medical devices?
Or am I being naive?
2
@ms How do you vote doc? Most docs I know vote conservative. They hated Obama for making them use EMRs, they hated Obama for trying to regulate their cash cow. Without safe and effective drugs you may as well become an herbalist.
10
As a physician I find this horrifying. As a potential patient--the same. The pharmaceutical landscape in the US is that of a large number of very inexpensive generic drugs, and another group of extremely expensive brand name drugs. I push hard to use generics in my practice because of the significant cost savings--many meds are $4-8/month even without insurance. Brand name drugs tend to be $10 and up PER PILL. It sounds like what we need is moderate priced generics that are actually reliably manufactured and tested. Most people would pay $10-20 per month for a med that they're getting practically for free now, if they could be confident in the quality.
298
@John in Georgia
Are people in countries like Canada dying at a greater rate than we are because they're paying less for drugs? That should be the first obvious question.
In the US 100,000 patients die per year of brand-name pharmaceuticals correctly prescribed by MDs in a hospital setting (plus another 150,000 from other medical errors) according to the AMA.
Since our healthcare is ranked 70th in the world, and dead last in the industrialized world (although we pay by far the most), shouldn't we be rethinking our assumptions regarding our approach to healthcare - starting with whether pharmaceuticals, generic or not, are a major part of the problem?
What is the comparative all-cause-mortality for each of the various disease conditions in poor countries that depend on generics compared to us? That's another obvious question.
Rather than assume generics have materially worse outcomes than full-price brand-name pharmaceuticals, show me the unbiased (non-industry funded) studies that prove that brand-name pharmaceuticals - with all their costs and side-effects - have better all-cause-mortality outcomes, than no pharmaceuticals at all.
That should be the most obvious question of all.
15
@John in Georgia: I agree with most of what you say, but having checked, I discovered that some of those brand name drugs are being compounded abroad and entering this country with the same lack of guaranteed quality control.
12
@Fourteen14: Perhaps John is not attacking the presence of generic drugs, but merely asking that they be subjected to meaningful quality control for dosage claim accuracy and purity before being released for distribution. I doubt that Canadian or European health officials would disagree. Price negotiation for inclusion on national formularies and quality control are two very different issues.
11
Ha! This sounds like a piece from a shill or the fox minding the hen-house wanting us to just take our expensive drug medicine and stop complaining.
I, for one, will continue ordering from foreign sources because dying from contaminated drugs is far less likely than declaring bankruptcy or getting nauseous at the high prices from taking American made drugs.
But more importantly, maybe this is the catalyst that gets some thinking about addressing the two issues--quality and price in the same sentence. Why don't we have big pharma manufacture overseas--too many others do to lower costs?
Or maybe the govt takes control of the process with either doing the research and or the manufacturing. But in any event, when it adversely affects so many people, something has to change. And we trust it will.
Vote for regime change in 2020.
42
@Our Road to Hatred... Regarding your first two paragraphs—your response to the article is again, as is another above, just emphatically stated opinion, and then without anything approaching the substantiation provided by the author of the article. Those at the political extremes are decried for ignoring science; well, the analysis of pharmaceutical APIs from generic manufacturers, with findings of impurities that could be tied to poor practice... this set of facts is science-based (and is a matter of the public record—google, e.g., "FDA Lupin letter" and see the first results that appear). And I will say this, as an individual trained in areas relevant to the evaluation drug manufacture, safety and efficacy: our research regarding the failure to maintain quality at off-shore generic drug manufactuing plants is consistent with the statements made in this article, on the whole. To close, I would say that if you have actual evidence to support your relative risk argument (the "dying... nauseous [sic]..." sentence)—please, state it.
As for your third and fourth paragraphs, which are more political in aim: yes, we can all agree that affordability of drugs is an important policy goal in the U.S. But not with sacrifice of the expectation that the manufacturing of generics is under control, and that the controls ensure a product identical to the name brand chemical entity (and so as safe as that actual entity has been shown to be).
3
@Our Road to Hatred
Regime change? Did you read the article? Baker didn't start his inspections until 2012 (any idea who was president then?), and the devil (not God) knows what it was like before that...although the article gives us some insights.
1
@Mark Shyres Unfortunately, you, and many others, are focused on the name Obama and thinking he had full command of policy making. But the regime I am referring to are the recalcitrant and obstreperous Republicans standing in the way of making reasonable changes to our dysfunctional healthcare system. So, dare tell us that the whole world's problems are Obama's making and Republicans had nothing to do with it.
When I asked where a pneumonia vaccine was manufactured the nurse was kind enough to check the package but country of origin was not listed.
I was already uneasy about generics knowing that they were not identical, such as different fillers being used that might cause a problem.
After reading this article (which I intend to save), I can only hope I do not have to consume any generic on a regular basis. Obviously, it might kill rather than cure.
42
@Mary Ann Donahue
The brand-name pharmaceuticals kill 100,000 every year. That's a lot more worrisome than generic fillers. You don't hear about people dying much in Canada from generics.
Generics are designed to be bioequivalent, they should act the same way in the body, and have the same safety and efficacy.
3
@Fourteen14 ~
My comment may have been mis-leading in that my core belief is the best drug is no drug but sometimes they are necessary and when they are I want the best one possible. Bio-equivalent is not an exact match.
Of course generics should have the same safety and efficacy but this article pointed out that they don't. Sometimes fillers cause a reaction or as one doctor posted here, even changing from one generic to another, can affect a patient.
I recently found out that soy is used as a filler in a generic thyroid medication used to treat hypo-thyroid. Soy can depress thyroid activity.
10
@Mary Ann Donahue
Yes, soy is certainly not good for a hypothyroid condition.
But all encapsulated and pill-form drugs have fillers and excipients to allow the encapsulation or pill making machinery to function without jamming up.
The potential problem with generics is that they may be inadvertently contaminated.
Usually the ingredients come from China (less so from India and almost never are they made in the USA) whether supplements, generic drugs, or brand-name drugs - all their ingredients are from China (mostly).
To guard against contamination these raw materials are quality tested before during and after encapsulation.
2
This is capitalism at its worst - and given human nature (sorry Ayn), why should anyone be surprised?
I believe that Elizabeth Warren has suggested that the Federal Government take over the manufacture of some generic drugs - and when you couple this story with the tales of the pharma bros hiking the prices of decades old generic insulin drugs to exorbitant level, we observe the primary arguments for her idea.
483
@Matthew Carnicelli... An unspoken but reasonably anticipated further consequence of the U.S. government entering the generics market is to move the entirety of that market away from real competition. Hence, while such a change may address issues of product quality, it may not have the fully desired impact on price—nor will it leave a level field on which all players can compete (as non-governemental competition is driven from the market by the player supported by incomparably deep pockets).
5
@Prof B: What do you recommend? The status quo is not acceptable.
25
@Prof B...Agree with your position on government interventions in principle, but I think that generics are a separate issue/market. Aren't *generic* drugs off-patent drugs, and thus no longer part of the fierce competition product-innovation, and big money categories of today's drug marketplace? Let companies profit from their innovations on a level, non-government playing field supported by the patent system; let patients profit thereafter from truly effective generics priced to reflect the cost of producing them safely by the government or by domestic (regulated) government contractors.
14
The question is why can't we make affordable generic versions of popular medicines right here in U.S. ? Why do our pharmaceutical firms not make generic medicines affordable? At the end of the patent period, no extension should be allowed even if the drug companies make some alteration in the molecular structure or the delivery system, just to renew and prolong the patent.We subsidies them enough already by paying exorbitant prices for the medicines unlike in any other countries in the world. Let them do R&D somewhere else.
58
@Shailendra Vaidya
Manufacturers of generic drugs do not do research and development. That is the province of the ethical pharmaceutical manufacturers.
7
@Shailendra Vaidya
We, the people, pay them enough through the funding of NIH research. Any drug company that wants to sell any medication in the US should be required to sell generics in their previous portfolio as well at production cost plus a reasonable profit not to exceed 100%. Failure to do so would automatically invalidate all their other patents on the American market, opening the door for any other generic producer state-side who would want to make that product and sell it at cost plus 75% profit margin.
That would get their attention very quickly.
48
@Shailendra Vaidya While I laud your opening question, much of what follows it are unsound statements. If you disincentivise the discovery of improved methods of drug delivery, no publicly traded company with fiduciary responsibility to its shareholders can pursue longterm, expensive RnD aimed at such improvements. Will society benefit from this, your proposed policy change (to remove all of the biggest players from drug delivery RnD)? Moreover, any change in "molecular structure" (as you reference in relation to another proposed prohibition) creates a new chemical entity—a new drug—which is neither the generic of nor in any way relevant to the initial on-market drug that we hope to make less costly. (Move or remove a single atom from a known, on-market drug and it is no longer that drug, and the whole game resets with regard to proving safety and efficacy. Likewise, invert a stereocenter, and you have the difference between the two enantiomers of thalidomide—the distinct pharmacologies and toxicologies of which are well known. Even the simplest apparent change in molecular structure is, simply put, a game-changer) In short, the policy proposals you make are not well grounded in the actualities of the drug discovery and development process, nor in the healthcare economic realities that drive that process at the most productive levels.
9
But in July 2015, F.D.A. officials decided to terminate the program and return to largely pre-announced inspections in India. When asked why, the agency declined to explain its reasoning and stated that “after evaluation of the pilot a decision was made to discontinue the pilot.”
No, really, why? What's going on? I hope journalists keep probing these questions until they get at the truth.
590
@Carol Yes--investigatiion of the F.D.A. officials responsible for this decision would be a godsend. There's surely a Pulitzer in it for someone !
121
@Carol
I want to say regulatory capture, but if a company in India could capture a regulatory body in the US, then we're in deep trouble.
The article also mentions "regulatory tourism" and I was surprised that it was taking place.
For example, at the SEC, the only thing you're allowed to accept is something you can drink through a straw.
24
@Carol, How sad that many note/agree that journalists must save us, not the FDA. We've so lost trust in so much of our government at the same time people want no cost access to the WORK of journalists.
36