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> very concerned that the FDA is far too quick with drug approval based on weak outcomes The current FDA requires strong evidence of safety, over a long period
by jefftk 7y ago
> very concerned that the FDA is far too quick with drug approval based on weak outcomes
The current FDA requires strong evidence of safety, over a long period. Prasad etc are arguing the FDA should be stricter on efficacy. In a pandemic, it makes sense to lower your standards for safety to get new treatments out sooner.
- zerkten 7y agoThis is required for good reason. It only makes sense to lower standards when there is going to be a realistic payoff. The general public place a lot of trust in the various parties to make the right decisions. Running with too much risk from adverse events is extremely problematic at different levels. People in pharma and in authority (FDA and other organizations) are intimately familiar with the need to strike the right balance and have a lot more considerations than you seem to assume they do.
- bluGill 7y agoThe FDA already allows lesser standards for efficacy for rare things. Which is why there are a lot of treatments for rare things - once you are on the market you can "wink wink" tell doctors about the more common thing you also work on.