Comment by changoplatanero
3 years ago
I get that the FDA is bad but how come there is no country anywhere on earth where these treatments are legal and available?
3 years ago
I get that the FDA is bad but how come there is no country anywhere on earth where these treatments are legal and available?
The FDA is not bad. The world has never had a shortage of liars, scammers, or snake oil salesmen. The term snake oil itself hearkens back to salesmen who would promise "medicines" to desperate people to con them out of their money.
Allowing trials to be bypassed and allowing people to pay for early access to unproven drugs would bring a flood of such be vendors and be bad for society, bad for medicine, and bad for ethics.
No one is advocating for "pay for access" or a means of bypassing trials that facilitate a "flood of [scammers]", so this is a straw man. You'd have to show why any design for relaxing regulation of trials is necessarily bad in aggregate.
The article even cites a case where the bureaucrats are confident in the safety of a trail drug but unable to approve for political reasons.
Not to mention the FDA allows plenty of snake oil supplements, etc. to be sold, so it's not particularly good at the goal you claim it's optimizing for.
FDA doesn’t regulate supplements as medication but food; however Federal consumer protection laws prevent making false claims.
I imagine allowing terminal non-trial participants access is more than just regulatory red-tape.
If understood one of the authors points it was that allowing non-candidates access could speed up approval. I think that is true, but that would require the same regimented process for administering the trial to ensure quality of data. The same would hold if there was an adverse event as well—patients need to be monitored closely to capture data to provide valuable to the clinical research results.
Supplements are regulated as food products as long as the manufacturer doesn't claim they treat or cure anything. The FDA allows them for the same reason they allow fudge brownies or Spam to be sold.
Because the mRNA vaccine approach is just about as cutting edge as it gets right now and only a few countries on the planet are any good at it.
The same is true for a lot of cutting edge treatments.
It quite strictly limits where such treatments are likely to be available.
This is a very interesting question. Why are medicines regulated federally? As I understand it (and IANAL) doctors, pharmacists and nurses are regulated on a state by state basis.
> Why are medicines regulated federally? As I understand it (and IANAL) doctors, pharmacists and nurses are regulated on a state by state basis.
Dr's typically practice in ~1 state while drugs are available in all states simultaneously.
Fifty states - of varying ability - trying to independently qualify all available drugs would be a nightmare of redundancy.
It would be an extraordinary disaster to kick that regulation back to the states.
Florida would probably outlaw all mRNA technology. Their FDA would refuse to approve any mRNA-based therapies, and so on.
We have seen the disaster that approach can cause in healthcare, insurance, abortion (reproductive health broadly), gay rights, etc. It's insane that we have state by state drivers licensing as an example that is merely highly inconvenient.
It's not a good thing that doctors and nurses are regulated at the state level. It's a horrible thing that contributes to the US healthcare system's vast dysfunction.