4 ms·
I don't know why this is allowed to go on. It's been going on for years with almost no consequences. At one point relatively recently they threatened to cut off
by derbOac 3y ago
I don't know why this is allowed to go on. It's been going on for years with almost no consequences. At one point relatively recently they threatened to cut off one generic manufacturer from the US market but then backed off, as far as I remember.
They know this is a trend, it's been documented in many articles over the last decade at least.
They could make unannounced spot checks, they could do more quality control sampling, they could increase accountability by mandating manufacturing information and links to safety violation records be printed on drug labels. And so forth and so on.
Sometimes I feel as if the entire medical industry in the US, and especially the drug regulation culture, has its head in the clouds with either some form of regulatory capture and/or narcissistic feeling of impunity or disregard.
Several years ago there was an article in a major news outlet about generics, and how lower income individuals were more likely to to choose brand name drugs over generics. The entire article, with interviews with physicians and medical experts, was framed around this idea that lower income individuals were less educated and didn't understand that generics were "chemically exactly the same" as brand names. This was going on at the same time as all this adulteration and dangerous manufacturing of generics. Not once did they mention that the possibility that maybe lower income individuals had a realistic, healthy fear of being screwed over by inferior products and lack of real oversight from authorities who are supposed to protect them.
The entire article was like a snapshot of problems with healthcare in the US: impoverished individuals getting screwed over by credentialed, overprivileged individuals in authority positions who are more concerned about maintaining a fiction of superiority and regulatory capture benefits than actually thinking of protecting the individuals who actually need help.
It's like cargo cult medical regulation, but with motivated ignorance.
The FDA needs to focus more on safety and quality control and less on the murkier and more questionable topics around efficacy and gatekeeping access.
- mwbajor 3y ago"...Sometimes I feel as if the entire medical industry in the US, and especially the drug regulation culture, has its head in the clouds with either some form of regulatory capture and/or narcissistic feeling of impunity or disregard...." Why is it ok to say this about anything not covid related?
- tanseydavid 3y agoIs that a rhetorical question? I think you know the answer.
- emodendroket 3y agoWell, they can't make unannounced spot checks easily without the cooperation of the host government.
- gg82 3y agoNot really. If you want to sell into the local market.... You must accept random checks.
- emodendroket 3y agoBut how "random" are they, because the government knows you're coming and can tip someone off if they value their export manufacturing industry enough.
- sacnoradhq 3y agoDefense-in-depth, especially at both the beginning and ends of the supply chain. All US pharmacies (retail and otherwise) should be required to capture a random sample of 0.1% of stock to the FDA for comprehensive mass spec characterization processed at federal labs with data released to the public openly. This data must be correlated with complementary point-of-production batch sampling. The data should agree, and would annihilate cheating, scamming, negligent, and incompetent manufacturers from harming patients.
- JoshTko 3y agoThis would be excellent.
- delfinom 3y agoPharmacies in the US are the last place to do it unless the FDA is going to compensate them in full. The shitshow that is the pharmacy supply chain actually puts pharmacies in shitty positions when it comes to drug pricing. Many independent pharmacies actually have to pay the distributor if someone uses one of those discount PBMs like GoodRX. Not to mention some drugs are just obscene at book value for the pharmacy. Instead, pretty much all pharmacies get their drugs from centralized regional distributors. Those distributors should be mandated to take part.
- nameless_prole 3y agoNot sure why any of this would be surprising. This is what happens when you allow for-profit corporations to basically run the health care system in this country. Of course they will do absolutely everything in their power to increase profit margins, with no regard for customer safety. And that includes regulatory capture, as well as cutting corners with regards to safety, and quality control.
- CamperBob2 3y agoNever mind that profit is why the drugs exist in the first place...
- nameless_prole 3y ago[dead]
- stcroixx 3y agoThe FDA is just pharma execs looking out for themselves. There is nobody at all looking out for us guinea pigs but ourselves. If the opiate thing hasn't made this clear enough for us to do something different, I'm not sure it's possible to change. I worked at a pharma company for a few years - what I saw and learned has led me to trust none of them or the FDA.
- jpollock 3y agoSampling tests will accept a base rate of failure, and governments have a bad habit of mixing up what sampling results mean. For example take a look at NZ’s corngate where they ignored the test results… https://en.wikipedia.org/wiki/Seeds_of_Distrust https://en.wikipedia.org/wiki/Seeds_of_Distrust
- meepmorp 3y ago> The FDA needs to focus more on safety and quality control yes > less on the murkier and more questionable topics around efficacy and gatekeeping access. no By all means, let's work out a way to use the FDA to better ensure quality control of generics (and other stuff), but reducing their focus on the efficacy of drugs is a terrible idea. You can't meaningfully talk about the safety of drugs without understanding their efficacy. Every medication comes with a cost benefit tradeoff, and the only way to make a reasoned decision is to have good data about the efficacy and side effects.