Re:Irregularities found during FDA inspection of Intas Pharm...
by meepmorp on Wednesday June 28, 2023 @10:41AM
(#36507158)
> 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.
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.