STAT+: The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals

WASHINGTON — Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of speedy drug approvals, and industry lobbyists are anxious to know how the agency plans to wield that new power, which includes criminal prosecution.

The Food and Drug Administration’s accelerated approval program is popular with patients who want treatments for life-threatening conditions as soon as possible. The program allows drug approvals based on test results that predict clinical outcomes, then companies confirm those results in post-market clinical trials. However, the FDA has had problems getting some drug companies to do those post-market trials, and the result is that some expensive drugs remain on the market for years without much proof that they work.

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