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In the last few years FDA has already moved closer to this with accelerated approval for mostly cancer drugs. Accelerated approval lets you get approved based
by aaavl2821 8y ago
In the last few years FDA has already moved closer to this with accelerated approval for mostly cancer drugs. Accelerated approval lets you get approved based on surrogate endpoints from smaller studies for patients facing fatal illness. Companies have to conduct full effectiveness studies, but can do this after the product is on the market. So FDA has already been doing a lot to help terminally ill patients get drugs that may save his / her life
Also "safety" is relative to the clinical benefit. The CAR-T drugs recently approved for lymphomas have horrible, sometimes fatal side effects. But they also save lives that would otherwise be lost. The risk / benefit would be very different in things like diabetes.
Also, safety is a moving target. Late stage studies are large and expensive bc a lot of safety events are rare. So early studies dont give you a full picture of safety
People forget that FDA exists in the first place to 1) protect people from dying from shoddily studied drugs (ie incompetence) and 2) snake oil salesmen (malintent). While in theory less regulation could enable more drugs to get to patients faster, more likely it would just incentivize more snake oil sales and poor science