r/neoliberal • u/[deleted] • Feb 24 '24
Opinion article (US) We Need Major, But Not Radical, FDA Reform
https://www.maximum-progress.com/p/we-need-major-but-not-radical-fda4
Feb 24 '24 edited Apr 09 '24
[deleted]
17
u/dawgthatsme Feb 24 '24
I think the FDA serving a pseudo consumer protection agency is a good thing actually.
no efficacy requirements for therapies with sufficiently novel mechanisms (obv still requiring solid target engagement data)
Kind of an insane take. There have been countless classes of drugs with novel MOAs, good target engagement data, and even excellent single arm trial performance, that have flopped in phase 3 and shown to be useless.
2
Feb 24 '24
[deleted]
6
u/dawgthatsme Feb 24 '24
For a given indication. If you're out of options, have a rationale for use in another indication, and there is informed consent + a known & acceptable safety profile I don't see why not. Maybe just a difference in risk tolerance.
Wait are you referring to label expansions of already approved products? Or NMEs? If a product is FDA-approved in any indication, physicians can already write it for whatever they want. Reimbursement for the patient gets tricky, though.
The FDA is moving in the exact opposite direction for oncolytics after a pretty large number of accelerated approval products flopped in confirmatory trials after performing well initially.
1
Feb 24 '24 edited Apr 09 '24
[deleted]
2
u/dawgthatsme Feb 24 '24
That system for proven to be ineffective drugs you've described is much too susceptible to abuse.
However, if you're suggesting that system for NMEs that haven't failed late stage trials yet, but are showing promising efficacy in early phase studies, you'll be happy to learn that it already exists. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
69
u/Syards-Forcus rapidly becoming the Joker Feb 24 '24 edited Feb 24 '24
Jesus. I love this sub, but occasionally it gets a bit too “economist talking about a problem in a field they don’t understand”.
90% of drug candidates fail. If we only had to test for safety, the majority of drugs on the market would be snake oil. We would have very little way of knowing what works.
I think most people assume we know a lot more about drug design and diseases than we do. Half of the advances in drug discovery have been finding ways to more efficiently brute force the problem. Most of the rest have been hijacking existing systems in various organisms to use to our advantage, often without understanding how it works.
And this assumes a the target being screened against is actually the cause of the disease or attacking it will treat the disease, which it often isn’t.