FDA Commissioner Marty Makary Resigns, Prompting Concerns Over Agency Direction

FDA Commissioner Marty Makary stepped down on Tuesday, leaving the agency without a permanent leader as it already faces turnover in its drug and biologics divisions.

Makary had recently appeared with Health and Human Services Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya in a brief video that claimed the Covid-19 vaccine should no longer be routinely recommended for healthy pregnant women and children, a message that resonated with vaccine skeptics.

In an opinion piece, former FDA principal deputy commissioner Joshua Sharfstein argues that Makary and his allies misread how lasting change is achieved at the agency, stressing that durable policies require fair and transparent processes.

Sharfstein warns that dismissing the agency’s institutional norms in favor of rapid, politically driven actions could undermine the credibility of the FDA’s regulatory decisions.