Threat in Your Medicine Cabinet: The FDA's Gamble on America's Drugs

https://www.propublica.org/article/fda-drug-loophole-sun-pharma

89•lentoutcry•7mo ago

Comments

soangry•7mo ago

I'm so angry right now. I did a deep dive into this at one point after being prescribed some generic Vyvanse through Sun via Dillons/Kroger. The pills smell like fish and seem like they didn't work at all. I checked some records from the FDA and Sun wasn't listed. I brought it up to my doctor and they just brushed it off.

I really hope another class action lawsuit is brought against Sun.

actionfromafar•7mo ago

Isn't the new direction of capitalism in America Freedom from Regulation?

cogman10•7mo ago

Yes. This is a clear example of why that's bad and why these agencies need funding and competent staffing.

throwawaymaths•7mo ago

these agencies had funding and competent staffing. they correctly identified that the factories were producing dangerous products.

cogman10•7mo ago

The funding comes in because they didn't have the funds to test the drugs. That's something I'd hope was happening with all drugs.

The competence comes in because they put availability above safety. That's an incompetent trade-off.

throwawaymaths•7mo ago

the real irony is that price and availability cannot be a consideration in approving indications for new drugs

billylb42•7mo ago

How did you arrive at that conclusion? All of the evidence provided in the article is prior to the “freedom of regulation” as you call it.

To me, it’s indicative of a rotting regulatory institution that lost its way. FDA is about safety, not low cost drugs. I don’t know how that mandate became mission critical for them but it happened before the current administration.

cogman10•7mo ago

Almost certainly happened because of Clinton and the FDAMA. It's a law that "cut red tape" IE removed safety protocols and standards.

These agencies are rotting primarily because they've been reworked to be business friendly over the last 40 years

derbOac•7mo ago

The US is long past the point where we need to stop talking about medical regulation generically. Some regulation and enforcement needs to be increased, and others need to be decreased or eliminated, at least in my opinion.

To me this sort of thing is fraud, and I feel like the FDA needs more resources and oversight to fight it. But with other things I think the FDA needs to back off completely, where it's overstepped its useful mission. I personally would like to see the FDA stop telling people what they can purchase or receive from whom, but spend more time guaranteeing that whatever is on the label is what it says it is and nothing else.

mindslight•7mo ago

To continue making a follow on point, also needing nuance - pharmaceutical manufacturing is exactly the type of industry that can and should be brought back to the US. First, through outright subsidies [0] to get the plants built. And then when domestic supply is high enough, through regulations prohibiting healthcare management plans from buying imported drugs.

[0] spending some of the surplus from having a reserve currency on deliberate policies rather than it being blindly given to asset holders

leereeves•7mo ago

How did you find out what factory the Vyvanse was made at?

sct202•7mo ago

You can figure out the generic manufacturer by matching the active ingredient with the pill shape, color, and imprints on a pill identification website. Finding the exact factory of that manufacturer is much harder though.

wl•7mo ago

If you're going to a pill identification website to find out the manufacturer of a prescription drug, you're working too hard. The manufacturer printed is on the prescription label.

LoganDark•7mo ago

Oh boy. I've had quite the experience with my own ADHD medication (dextroamphetamine in my case, which is essentially the stuff Vyvanse metabolizes into), and when they substituted for a different brand, that brand was completely different and so totally not compatible with this body. So now I have a Brand Medically Necessary because when they tried to switch it on me I went into hypertensive crisis :)

pyuser583•7mo ago

The drug you mentioned had a reputation for these sorts of problems.

jnsie•7mo ago

I have nothing but respect for physicians but my experience is that each acts as a more narrow filter than the last and, beyond their direct expertise they have very little expertise in billing, pharmacy or anything outside of their direct domain, nor do they have the bandwidth for it. Add to that the advertising phenomenon of 'ask your doctor about X' and I suspect that anything beyond the immediate care you're receiving has very little chance of receiving thought/cogent answers.

xpe•7mo ago

I respect doctors (and people in general), but I don’t give the medical profession a passing grade. To speak in generalities (there are exceptions), their training is somewhat insane: long hours, sleep deprivation, knowledge cramming, and more. Their daily practice leaves little time or incentive for keeping up with studies. Most were not adequately taught statistics in the first place. To vent a bit more, I don’t think it is unfair to say the system is crap. If we could redesign it from scratch, understanding human nature, how people learn, and the need for ongoing learning, and evidence-based medicine, it would not be this. None of this is meant to assign blame to individuals.

thfuran•7mo ago

>Their daily practice leaves little time or incentive for keeping up with studies.

Their certification requires it, at least to some extent.

xpe•7mo ago

Two responses. First, CME is criticized as being largely influenced by industry rather than primarily intended to advance medical learning. [1]

Second, assuming medical continuing education is something like 20 to 40 hours depending on the region [2], this feels meager and insufficient. In contrast, think of how much learning a software developer does during a year -- perhaps close to 5+ hours per week on average! [3] Very different contexts, very different incentives.

[1]: https://www.chronicle.com/article/lessons-from-a-professors-...

[2]: Based on very quick research: could be off -- corrections are welcome

[3]: There are many differences, of course. Just to pick one example: to what degree does a software developer's continuing exploration into an area (such as a specific business process that their application needs to understand) help their craft? Does it improve their skill level? Does it result in transferable skills? Does it improve the quality of their work?

thfuran•7mo ago

A software developer is not required to do any continuing education at all.

xpe•7mo ago

Ok, but you are moving the goalposts relative to my original quote: “Their daily practice leaves little time or incentive for keeping up with studies.” My first point is that software developers (generally, more often than not) have the time and incentive to learn on an ongoing basis.

Second point: if continuing education has to be mandated, it is likely a symptom of a system that lacks proper incentives.

On the positive side, as more patients educate themselves and press doctors for statistical understanding and synthesis across studies, “Dr. Expert’s” stale knowledge will no longer fly.

thfuran•7mo ago

Mandated continuing education isn't a sign of missing incentives, it is the incentive. Being required to do something to keep working in the field seems like a pretty strong incentive to me.

But I certainly won't dispute that doctors in most systems in the US are overworked starting at least in residency.

xpe•7mo ago

We both know there is a difference between intrinsic and extrinsic incentives. This difference underlies so many things, including: (i) justification for regulatory frameworks; (ii) individual motivation; and (iii) likelihood of follow-up / compliance.

JumpCrisscross•7mo ago

> if continuing education has to be mandated, it is likely a symptom of a system that lacks proper incentives

I’m a pilot and work in finance. They both have continuing-education requirements. The ones in the former are practical and helpful. The ones in the latter are mostly performative. (In some cases, arguably counterproductive.) The existence of continuing-education mandates per se tells you almost nothing about the system as a whole.

xpe•7mo ago

Point taken. Interesting example. Do you have some theories about why continuing education requirements are so different in aviation compared with finance? Some factors might include: individual skin in the game, observability, feasibility, and the temporal and causal distance from action to consequences.

JumpCrisscross•7mo ago

> Do you have some theories about why continuing education requirements are so different in aviation compared with finance?

Culture of professionalism. That’s kind of a bullshit answer, but it’s the closest phrase I can come to that encapsulates pilots taking the rules seriously, both because they’re there for a good reason and the FAA isn’t afraid to yank your wings, but also because the FAA isn’t usually making rules to seem tough on pilots or otherwise infantilise them, it’s following an evidence-based approach that’s explicitly endorsed by pilots. (After a crash, you aren’t trying to find who to blame. You’re trying to prevent the next crash.)

potato3732842•7mo ago

Software developer doesn't hold a certification from a trade group that has a government violence backed monopoly on deciding who can make a buck performing said craft.

thfuran•7mo ago

Yes, they're missing a pretty strong incentive.

kjkjadksj•7mo ago

It is a rubber stamp cert. I’ve been to a continuing medical education talk. It is your bog standard visiting scholar giving a 45 min talk of their research. Lecture hall is sleepy aside from the usual suspects. Sheet pizza from the cheapest place in town is being served. People are nodding off in the back. About the only way you can tell this is a continuing medical education event is the clipboard and pen being passed around for MDs to sign their name along with a signature.

It is a far cry from actual class. Learning isn’t required only saying you were there.

derbOac•7mo ago

I have plenty of criticisms for the physicians lobby in the US, but kind of agree this is one area where I'm not sure the problems lie in physicians (outside of some very general sense that they tend to be in key positions of influence in healthcare systems in government and elsewhere).

I do think it's a good example of why pharmacists should maybe have more power in the drug prescription process, and also wonder why insurance companies or pharmacies don't ban drugs from certain places and/or sue them themselves more often.

timr•7mo ago

The "fishy odor" is a classic hallmark of amine-containing compounds [1], of which Vyvanse has three [2], including a terminal amine, which is so infamous (at least in the di-amine form) for being smelly that they have delightful names like "Cadaverine" [3].

I don't know if the completely purified drug officially has an odor, but usually you get some free amines that come along for the ride. More likely, some got outside of the gelatin capsule during shipping.

[1] https://www.science.org/content/blog-post/amines-and-landsca...

[2] https://en.wikipedia.org/wiki/Lisdexamfetamine#/media/File:L...

[3] https://en.wikipedia.org/wiki/Cadaverine

eightys3v3n•7mo ago

I pursonally took Vyvance brand name for over 1.5 years by opening the capsule and mixing it in a bottle of water. Never did it have a smell or taste. Even if Vyvance is manufactured with compounds that often have a smell or taste associated with them, the fact that this generic smelled almost certainly speaks to lower quality controls than the brand name based on my experience. At the very least it would speak to them choosing a component that smells over one that does not.

timr•7mo ago

> Even if Vyvance is manufactured with compounds that often have a smell or taste associated with them

Just to be clear: it's not "associated" -- the drug itself probably smells, and you just didn't notice it. It's very, very common with drugs containing amines.

Metformin, for instance, has a distinctly fishy odor (but it also has a couple more amines):

https://en.wikipedia.org/wiki/Metformin#/media/File:Metformi...

yababa_y•7mo ago

from my experience washing some mediocre amphetamine cooks,

the fishy smell is not characteristic of pure amphetamine, but leftover methylamines from synthesis.

vyvanse adds a lysine but none of these amines are free. it’s odorless as well, but any lysine esthers leftover will stank.

it was shit product

eightys3v3n•7mo ago

Yes, that could be true, it even likely is. The point I was making is that if I can take apart the capsule and drink the contents mixed with water without noticing a smell or taste, there is a significant difference between brand name Vyvance I aquired during that time and what the other commenter acquired. Given the odor is undesirable, I would say the meds they acquired were much lower quality than the brand name ones I had (which of course I am just assuming are reletively representative).

soangry•7mo ago

Good info. Thank you. Only one batch had that very distinct fish odor. Was right after the Vyvanse patent lapsed and went generic.

VeninVidiaVicii•7mo ago

I had the same exact issues on generic Vyvanse, which also causes me intense palpitations compared to the brand-name, I legit thought I was going to have a heart attack several times a day. So much so, that I quit it altogether—I couldn’t stand the side effects or the constant unavailability of the brand-name.

fn-mote•7mo ago

The report is horrifying, but in the current US political climate it is very hard to see how a government agency could undergo any positive cultural change.

A quick search finds recent firings [1] and [2]... who would lead a change?

[1]: https://floridianpress.com/2025/06/rep-wasserman-schultz-sla... [2]: https://fortune.com/2025/02/16/trump-cuts-fda-layoffs-food-s...

soangry•7mo ago

The issue I described existed before the administration change.

Neither's parties people wants to be poisoned.

komali2•7mo ago

> Neither's parties people wants to be poisoned.

Voters for one party keep taking horse medicine and we can't seem to stop them when they experience negative side effects, and we couldn't get them to get vaccines even as their friends and loved ones were dying begging for it at the last minute. There's definitely a party divide here.

Loughla•7mo ago

I have no opinion on ivermectin. I don't think it's a miracle cure, but I also have no idea about the actual research in that space.

But.

My assistant at my last job was all in on it during COVID. It cures everything, according to her. The moment when her cognitive dissonance hit its peak was when she gave her husband ivermectin for a cold, and was absolutely astounded that he ended up in the emergency room with diarrhea and dehydration. She was convinced it was "vaccine injury" and that he did a sneaky and got the COVID shot without her knowing. Spoiler; he did not get vaccinated.

It really was pretty funny at the time, but also sad. She was sort of my bellwether for nuts behaviors. When she started spitting Q-anon talking points, as a middle aged woman completely disconnected from anywhere that should exist, I knew we had problems.

atmavatar•7mo ago

Ivermectin is an anti-parasitic. Since having parasites on top of another condition is generally worse than just having the condition, it's not uncommon to see a positive impact when taking ivermectin for a variety of conditions in places where parasitic infections are common, if only because the body no longer has to fight the parasites in addition to the condition.

Since anti-vaxxers during COVID were looking for anything to take the place of a vaccine, ivermectin was an easy thing to latch onto.

hnuser123456•7mo ago

On the other hand, my liberal parent gave me stimulants for 8 years that made me anxious when I previously wasn't, and killed my appetite so hard I couldn't take more than 1-2 bites of anything at dinner, and now I'm 32 looking like a 16 year old but with the fatigue of a 64 year old.

derbOac•7mo ago

I share your skepticism about false equivalence in general, but have to admit this particular issue to me gets at the heart of serious problems in US healthcare, and I don't see either party really addressing it. The way in which these problems get ignored by each party, and the rationale for doing so, is very different but so far I see both parties as either turning a blind eye to these problems, or lacking vision.

tacitusarc•7mo ago

It feels like there’s a house on fire and one party is like, “It’s fine, I don’t see the problem and neither do you” and the other party is like “OMG the house is on fire, quick pour gasoline on it.”

I’ve sort of accepted it’s going to burn down. The problem is that it doesn’t seem there’s anyone capable of rebuilding it.

wat10000•7mo ago

I’m pretty sure one party’s people does want to be poisoned, given the consistent advocacy for reduced pollution controls and such.

kgujdtjof•7mo ago

Manufacturing drugs in India is like manufacturing them in Haiti. Why would anyone think that would be a good idea?

barbazoo•7mo ago

Care to explain?

quickthrowman•7mo ago

150 million people still shit in the open in India. Is that a sufficient explanation?

It’s substantially better than it used to be. FWIW I believe the people of India deserve to have proper sanitation.

barbazoo•7mo ago

> 150 million people still shit in the open in India.

Yet they landed on the moon [1], how about that. I assume they're theoretically capable of producing medicine.

https://en.wikipedia.org/wiki/Chandrayaan-3

quickthrowman•7mo ago

-Who funded the moon mission? What are their incentives?

-Who owns the pharmaceutical plants? What are their incentives?

barbazoo•7mo ago

And who is moving these goalposts around?

quickthrowman•7mo ago

What goalposts? The government funded the moon mission, they’ll spare no expense in making sure their vanity project succeeds.

Private companies own the pharmaceutical plants in India, their incentive is to maximize profit.. in a country with lots of corruption and poor sanitation.

I’m not making the claim that 10% of India defecating in the open is a moral or cultural failure, I’m saying that, in conjunction with the corruption, it does not inspire confidence in manufacturing goods that need to be sterile.

soangry•7mo ago

I'm not sure that's the brag you think it is.

It's the same kind of brag the USA has. We have this giant military but have a broken health care system.

India has a space program, but a huge portion of their population doesn't have toilets.

ASalazarMX•7mo ago

People still joke about chinesium smoke escaping cheap electronics, yet China likely made many quality devices you use daily. It can work, but it needs strict controls.

cowpig•7mo ago

I have a pet theory about the medical industry in the USA.

The US is the most pure-capitalist nation on the planet, and medical services are as bad a fit as it gets for a market economy:

* interactions with the market are ideally as few as possible

* there is massive information asymmetry

* people can't "shop around" during medical emergencies

* the externalities are orders of magnitude more potent than the forces directly acting on a transaction

* most importantly, individuals in many cases *literally cannot exit the marketplace* (unless you consider death a viable consumer choice).

That second property creates a market incentive to squeeze every consumer dry. What can they do about it, really?

But it's insanely unethical, and extremely against the common good (externalities abound).

Those forces push the middlemen, the insurance providers, to do horrible shit. And since they are the middlemen with all of the power, and interact with literally every market actor, the culture of pure evil seeps into everything. Clinicians either becomes numb to the fact that insurance companies will literally just not pay things they agreed to pay, or live a life of endless frustration.

This is just "how it is", and so everyone, including regulators, shift their overton window to be able to function in a decrepit, toxic system.

dantheman•7mo ago

The majority of medical care and expenses are not emergency.

ASalazarMX•7mo ago

The parent comment never implied that every medical interaction is an emergency. I can see why they mention it, as emergencies are usually the most expensive medical transactions by far.

Was that the only thing you got out of it?

tacitusarc•7mo ago

I completely agree with your points about medical services, but I think it’s important to point out the US does not have, and never really has had, a meaningful market economy when it comes to healthcare.

idopmstuff•7mo ago

For more on this, I highly recommend Bottle of Lies by Katherine Eban. Fantastically written book that goes deep on this topic and will absolutely horrify you about everything related to the manufacture of generic drugs.

ls612•7mo ago

My mom was a hospital pharmacist when she was still working and was beating the drum on this all my life as far as I can remember. All it accomplished was getting her called racist and xenophobic and losing friends :(

idopmstuff•7mo ago

Good for her - I'm just astounded that I didn't know any of this. Even the fact that generics only have to be within something like 20% of the active ingredient of the non-generic was surprising to me; I thought they were basically identical.

But the quality of manufacturing stuff is just unbelievable. You take for granted that our medications are highly regulated and it turns out to not be remotely true...

raincom•7mo ago

Ask the US companies to pay more to the contract drug manufacturers in the third world. But these US companies want the cheapest bidder. You get what you pay for. Pay more, inspect more. It is as simple as that. You can't have the cheapest guy to deliver on every metric. Instead, you get contract manufacturers, who cut corners after a few good batches.

soangry•7mo ago

If it's worth anything, I keep telling Sam's Club managers to hire more staff. I also tell the employees at Dillons to unionize. I'm pretty sure I'm going to get banned from their stores soon.

AbstractH24•7mo ago

I recognize this article is singling out all the negatives and overlooking all the people who benefited from the medications.

But what is the overall likelihood that an individual will suffer significantly from some statistically unlikely event in modern medicine? There are so many.

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