Bloomberg Law
Aug. 19, 2022, 3:00 PM

More Than Half of Fast-Tracked Drugs Fail to Offer High Value

Jeannie Baumann
Jeannie Baumann

Most fast-tracked drug approvals by US and European regulators fail to provide high therapeutic value, in a study researchers say underscores the need for stronger government oversight.

The study published Friday marks the latest effort to evaluate regulatory pathways that allow for earlier approval of drugs based on a prediction they will offer a clinical benefit. These programs have faced greater scrutiny over whether they are offering the game-changing benefit they’re designed to—particularly as an increasing number of drugs are using these pathways.

Critics of the accelerated pathways have cited delays in some companies meeting post-market requirements to confirm whether ...

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