FDA Nominee Makary Pledges 'Independent' Staff Review Amid Agency Cuts

Marty Makary, President Donald Trump's nominee to lead the Food and Drug Administration (FDA), has vowed to conduct an "independent assessment" of agency staffing if confirmed, following recent layoffs ordered by the Department of Government Efficiency. At a Senate confirmation hearing, Makary addressed concerns about the agency's personnel situation while highlighting the FDA's rapid growth over the past decade.

Staffing Concerns and Agency Growth

Makary, a surgeon from Johns Hopkins University, emphasized his support for the FDA's professional career staff, stating, "I'm a big believer in the professional career staff at the FDA." He promised to ensure that staff have "all the resources they need to do their job well" if confirmed as FDA commissioner.

However, Makary also noted the significant expansion of the agency, pointing out that the number of FDA employees has doubled since 2007, now totaling around 19,000. This growth has been accompanied by a more than tripling of user fees collected from drugmakers to support the FDA's review work during the same period.

Concerns Over Recent Layoffs

Senators from both parties expressed concerns about the recent layoffs at the FDA. Sen. Susan Collins (R-Maine) questioned the decision to lay off "probationary" employees, citing the agency's need to bring in new scientists and researchers to replace retiring staff. Sen. Tim Kaine (D-Va.) objected to the broad nature of the layoffs, asking if future personnel decisions would be made more strategically.

In response, Makary pledged to take a "surgical" approach to staffing decisions if confirmed. He stated, "You have my promise that if confirmed, I will do my own independent assessment on personnel."

Industry and Investor Reactions

While drugmakers and their lobbying organizations have largely remained quiet on the FDA layoffs, some industry leaders have begun to voice concerns. John Crowley, head of the trade group BIO, warned against continuing with "haphazard layoffs" in a recent op-ed, stating that such cuts lack "the strategic insights necessary to modernize and reform our nation's health care agencies, especially the FDA."

Investors are also monitoring the situation closely. RBC Capital Markets analyst Brian Abrahams noted that investors remain cautious about the "risk of FDA attrition" and the potential "disruption this could bring to the review processes and recent flexibility."

As the confirmation process continues, the pharmaceutical industry and its stakeholders will be watching closely to see how Makary's potential leadership might shape the future of the FDA and its critical role in drug development and approval.