FDA regulatory moves reflect a steadying ship

Among this week’s FDA approvals, two decisions on controversy-marred applications suggest the agency is steadying after the tumultuous tenure of former Commissioner Marty Makary. A third, a breakthrough from Takeda, gave narcolepsy patients a first-in-class therapy.

FDA’s decision to submit two of the therapies to advisory committees was itself a sign the agency is reverting to a more conventional approach. The fact that it approved one based on a committee recommendation that contradicted the views of agency reviewers is further evidence that it is shaking off top-down decision-making...