The extremism of the FDA’s Marks and Prasad has come with costs

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

In the context of a rare and progressively fatal disease for which there are no available treatments…

Is it better to approve a drug with undetermined or debatable benefits that is later found not to be effective?

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