The FDA Hasn't Inspected This Drug Factory After 7 Recalls for the Same Flaw
propublica.org
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The problem now is almost every generic drug is made in India and I'm having a near impossible time avoiding them. As you can see, they are no longer being properly investigated. What's worse is the pharmacies are also contributing to the problem by not cycling out their stock of older medication. This was evident when I reported one of pharmacies for medication that basically disintegrated into my hands. After they were contacted by state inspectors (I got a follow-up email saying as much), the pills were of noticeably higher quality even though it was the same manufacturer.
I honestly suspect a good majority of Americans are using prescription drugs that are either somewhat ineffective or come with side effects that otherwise wouldn't be there with proper inspection. One common thing you'll read online is that "all generic drugs should have the same quality and active ingredient", but clearly that is not accurate when factories are either failing inspection or no longer being inspected at all despite numerous previous failings.
Are the brand-names manufactured to a higher spec?
Even though you are right - everyone should demand safe generics, because there is no healthcare in any country without them - your words will get lost in the mire of the mind of the libertarian Hacker News 22 year old, who takes no non-stimulant medicines, telling you nobody is forcing you to do this or that, that you should just die.
When a brand name drug goes off patent, everybody (including competitors and generics manufacturers) already has a pretty good idea of both 1) the commercial market for generics, and 2) the components of the drug.
What isn't shared are trade secrets disclosing manufacturing processes, as well as the inactive ingredients+formulation of the drug. Competitors & generics OEMs are left to guess and use best judgment when they create competitors to the original, and sometimes they make bad decisions.
Actual manufacturing quality should be equally high, but the resulting drug may not end up being exactly the same as the branded version, even if the differences have nothing to do with the active ingredient.
edit not to mention the processes can be wildly different too as those are not part of the initial disclosure to get patent protections.
In every example I've come across, branded medicines (at least for the big companies) are made in the manufacturers own factories.
Pfizer, Novartis, Merck, etc all have their own factories in Europe and North America.
> The problem now is almost every generic drug is made in India and I'm having a near impossible time avoiding them.
How often do you find pharmacies are able to meet your request? How can you even tell? When I receive a prescription I have no idea where it was manufactured.
Eban's "Bottle of Lies" book is shocking: https://www.katherineeban.com/bottleoflies
Peter Attia on Youtube also did an investigation on this.
If you're lucky your drugs have the right amount of the active ingredient. If you're unlucky they have chalk dust in them. If you're even more unlucky, they have carcinogens in them.
No, it is very much not. https://www.merriam-webster.com/dictionary/carcinogen
> I think you just mean the bad ones can cause harm
There are no "good" carcinogens. They're all bad. They all cause harm and cancer because that's the one and only meaning of that term.
I suppose I should ask the pharmacist, because the quality control is all over the place on this medicine.
I'm actually not at all an isolationist. I love trade. But there are certain things a sovereign nation should not outsource. We had a warning with COVID about this but apparently saving money is more important.
When it's something simple like Bactrim the price difference is large percentage-wise, but still palatable. But for so many other drugs the price difference is 1000's of percent between the two, even if I use stuff like GoodRx.
The prices on the drugs from india have so undercut generic manufacturers elsewhere that they have to resort to either harder-to-manufacture/more-expensive generics, or just go out of business.
So much of the blame for this, at least in the US, lies at the feet of the health insurance and pharma industries.
I mention as soon as possible that I'll be requesting name brand prescriptions. If they get it and clearly understand why I'd request name brand, then, great, they've passed the test and we can continue. If they balk, I explain:
1. That the teva-brand generic budeprion XL that I received in place of name-brand Wellbutrin XL in 2010 caused a catastrophic relapse of my symptoms -- and was shortly afterwards withdrawn and banned from the US market.
2. That after I was switched to generic amphetamine salts from the name-brand Adderall formulations I'd been taking, blood tests revealed -- repeatedly -- that there were no detectable amphetamine metabolites in my body, and I was incapable of functioning. As soon as I switched back to a name-brand formulation, the metabolites suddenly reappeared at the expected concentration in my bloodwork, my symptoms abated, and I was able to resume the parts of my life that had derailed in the intervening months.
3. That if the doctor has any problem with or doubts about my requests for name-brand-only, dispense-as-written prescriptions, I will find a different psychiatrist.
doesn't seem like it based on the FDA Fact Sheets. where are you seeing the annual increases?
"The FY 2025 Budget provides a $7.2 billion total program funding level for the U.S. Food and Drug Administration. This includes an overall increase of 7.4 percent or $495 million over the FY 2023 funding level" [1]
"The FY 2024 budget provides a $7.2 billion total program level for FDA. " [2]
"The FY 2023 budget provides an $8.4 billion total program level for FDA." [3]
[1] https://www.fda.gov/media/176923/download
My understanding is that the FDA gets paid either way and have a monopoly on approval. It's not like the users will go somewhere else if they received an unfavorable ruling.
This is broken down on the FDA's website[1].
[1]: https://www.fda.gov/industry/fda-user-fee-programs/fda-user-...
I did some contracting for a federal agency, the area I was meeting with was a hot area… Aeron chairs, nice office spaces, new computers.
One time we had to cut through an office area on the other side of the floor that was being starved. 1970s orange carpets, DOS computers, people who looked like they worked in a coal mine.
Same agency, different budgets. IRS is the famous example, Republicans when they control the house always starve the enforcement division as much as possible.
When I worked for an agency, there was always a mad rush at the end of the year spending millions on useless crap. The rationale was that any budget surplus would be reallocated and cut from next years budget, putting future programs at risk.
Actually, this is mostly an issue with process. Covid shutdowns caused a huge backlog. Offshore manufacturing gets notifications of planned visits versus unannounced visits for onshore facilities. Sure, every org will say it can do more with a bigger budget. But more money for inspectors will do little to retain them when some of the biggest complaints are the travel requirements leading to reduced work-life balance.
Yes.
The LD50 of KCl potassium chloride (like you use for cooking) is approximately 2.5 grams per kilogram (g/kg) when ingested orally. For example, a 165 lb person would have an LD50 of 190 grams. These are 750mg pills. Even if they release all at once, they are still >2 orders of magnitude lower. the daily recommended intake of potassium is 3 grams, or about 6 grams for KCI, or about 8 pills.
When I skip meals, I will often drink 750mg of KCI in water for the electrolytes.
That said, maybe there are populations which are much more sensitive. I suspect the lawsuit would be more informative to learn more.
I found a few cases of oral potassium chloride causing heart attacks, though at levels at least an order of magnitude greater.
Yeah, the LD50 is misleading for potassium in this context. Most people can tolerate higher doses completely fine, but people with kidney and cardiac issues can die from doses on the order of ~10g (typically due to arrhythmias/fibrillation).
Put another way, the theoretical ratio of LD50 to LD1 is way larger for potassium compared to most other common meds.
NOT that the flaws discovered are low priority or that the product is low risk or that they actually do recalls or whatever. The lack of manufacturing control is the actual flaw. And because of lack of control it's pretty likely that an inspection would uncover more problems.
We see this all the time: people point out that a problem is minor, therefore not a big deal.
Or we see a food manufacturer poisoning a bunch of people with product X produced in factory 123. And so inspectors are eventually sent to the shut-down section 123-X (where they uncover a million other problems.) And no inspectors are sent to section 123-Y or 123-Z or any other factory. No tests are performed on other products out in the distribution channel.
That to me is insanity. The uncaught manufacturing problems do not happen out of acts of god, randomly, as some inevitability. They are not caught because management and staff do not care and test and check for them. They are not random instances but likely highly correlated with other problems. Because the root is lack of care and lack of control. In the case of a food or pharma manufacturer caught with their pants down, ANY such instance should be the cause of a major call to order within the company. That one instance is a symptom of lack of management and staff effectiveness. Any lesser reaction should be the call for them getting to the top of the inspection priority list worldwide.
And this very specifically is absurdly insufficient:
> “When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively,”
Or after inspection at ONE factory:
> “Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,”
How can this NOT be taken as a sign that the other factories are likely also affected?
Which is why for me any such lack of response (company-wide call to arms) results in the company going on the blacklist. ... Which does make shopping difficult.
Does FDA not have the authority to fine factories which fail inspections?
I have also heard that getting a factory certified as clean for GMP is a huge process. How are foreign factories entering the market if they have never been inspected?
Emissions inspections and financial audits are self funding. You pay to get the test because you have to.
edit: The parent comment is flat-out incorrect. Not sure where you are getting your information from.
> FDA inspections are generally unannounced, with a few exceptions. From FDA's "What to expect during an FDA inspection" https://www.fda.gov/media/142762/download
https://www.fiercepharma.com/pharma/fda-must-solidify-plan-f...
FDA has authority to fine factories but like most things right now, these drugs are only cheap source of medicine for many so Medicare/Medicaid is leaning not to cut it off.
Inspecting Foreign Factories is obviously much harder even cost aside because inspectors don't want to do it and the person spends almost 4-6 days traveling.
However we have a single payer health system for the most part (you can get medications that aren’t through the system, but you pay full non-US market price), so the big stick is “well we’ll buy from someone else”, easier said than done of course but it seems to work.
Our medical regulator (different body to the purchaser) doesn’t do inspections overseas but does random tests on the products imported to check the quality.
> The FDA Hasn’t Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly
It turns out there is no way in the US (at least according to my doctor) to write a prescription as "anything but Glenmark", so I was out of luck for that prescription. Fortunately I can take the immediate release version at only a minor convenience hit, so that's sorted. Still... very frustrating.
I guess I should have filed an FDA complaint. It's always hard to know what's "my problem" and what's actually their fault.
The explanation I've gotten is that the bad pills gave me a massive salt dose very quickly, raising my blood pressure sharply. This increased the pressure on my eyeballs, of all things, producing visual effects indistinguishable from a scintillating scotoma (but not actually those, because it's really coming from the eyeballs themselves, not the brain). The pressure difference crushed my eyeballs slightly and ruptured blood vessels, releasing floaters. They have gotten better over the last couple years but they are definitely still there.
Fuck Glenmark.
The standard advice for dealing with floaters is "wait six months for them to settle out", so I didn't bother seeking out a doctor. And most of them have settled (maybe still are settling?), but it's now been long enough that I should probably check in with someone....
every time i read something like this - and it is with increasing frequency - i can't help but recall The Formula as laid out in Fight Club.
in this case, a few people dead is just 'doing business,' i guess, since it isn't crossing whatever 'n' their threshold is at. which is clearly MUCH greater than 0...
To be clear, the formula laid out in fight club is illegal, and not practice in US medical, but similar tradeoffs are still there.
If it is too hard and expensive to reduce risk to an acceptable level, the product isnt made. In many cases, if the product isnt made, more people die than if the product has residual risk.
and even then ... the industry is complex, costs are high, funding is always finite, keeping product quality consistently high is a lot of effort, which is definitely not cheap, etc.
many generics "don't break even" as far as I understand
there's a lot of potential for having some kind of centralized mass-manufacturing setup of these low-profit drugs. but the cautionary tale is the baby formula brouhaha. it shouldn't be a single point of failure. but then it's not that low cost, right? so it should be some kind of industry-wide system. (ie. every big manufacturer should have some capacity that is pooled for these. but it must not hinder the market, it must not be a barrier to entry, and it must not lead to manufacturers exiting the market. so many considerations and challenges.)
protectionism (high tariffs)
market concentration (ie. suppliers dropping out of the market due to a government program favoring/subsidizing some manufacturers, thus distorting prices/preferences/demand)
recurring unaddressed problems at Abbott's plant until kids died :/
And verifying that a factory has adequate QC doesn't just mean walking the factory floor to check everything is correct (although that is a good start). It also means checking that the factory has a QC program: that management has implemented quality checks and acts on quality issues; that staff are able to flag issues (without retaliation and with reports that get acted on); that they demand the same from suppliers etc etc.
We absolutely need the FDA going to factories, not (just) to observe the actual technicians but to inspect the overall way the factory functions wrt quality.
In the case of potassium pills, they should be quality-testing the extended release mechanism. It's possible an inspector wouldn't be able to catch that their quality testing is shoddy or non-existent in every specific case, but if they show up and see a pattern of bad manufacturing processes, that's important to act on.