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.
Instead, pretty much all pharmacies get their drugs from centralized regional distributors. Those distributors should be mandated to take part.
Why is it ok to say this about anything not covid related?
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.
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.