
Endpoints News reports “faster FDA drug approvals may reflect less rigorous evidentiary standards, a new analysis” published in JAMA suggests. Incentives have “made the US system of getting drugs approved easier and the agency seemingly more flexible.” Regulatory incentives – including “fast-track and breakthrough therapy status, orphan drug designations as well as accelerated and conditional approvals – have diminished review times and encouraged the use of surrogate endpoints.” The analysis “found that that this evolution has led to the FDA generally accepting less robust evidence, all the while shortening its review times.”
From the news release of the American Association for Justice.

