FDA cuts put orphan, novel and repurposed approvals at risk

Massive and poorly planned layoffs at FDA will almost certainly lead to missed user fee deadlines. But unless FDA Commissioner Marty Makary reverses course quickly, the damage will extend far beyond short-term delays.

The purging of FDA’s scientific leadership and support staff in recent weeks threatens to undermine the agency’s drug review capabilities from both the top and the bottom. According to current and former FDA officials, the aperture for approvals will almost certainly narrow, meaning drugs that could have been developed in a fully staffed FDA are likely to be rejected, delayed or abandoned. ...