Marty Makary, the commissioner of the Food and Drug Administration, has marked his first 100 days in charge of the agency that regulates a quarter of the U.S. economy with a miniature media tour and a series of bold-sounding announcements.
One of those announcements might result in big positive change — if Makary and the FDA can follow through. But others have the same issues many of the commissioner’s announcements have had so far: They threaten to ignore the way the FDA has worked historically, risking the best of an agency that mostly has functioned well for the sake of an uncertain payoff.
First, the really great idea: making public complete response letters (CRLs), the rejection notices that companies receive from the agency when their medicines are not approved.
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