Listen to the article
Marty Makary, President Donald Trump’s nominee to run the Food and Drug Administration, said he would undertake an “assessment” of agency staffing if confirmed but didn’t offer any views on the appropriateness of layoffs ordered by the Department of Government Efficiency.
At a Senate confirmation hearing Thursday, the Johns Hopkins University surgeon said he wasn’t involved in decisions to fire hundreds of FDA employees, but vowed to make sure that the staff has “all the resources they need to do their job well.”
“I’m a big believer in the professional career staff at the FDA,” Makary said in response to questions from Sen. Angela Alsobrooks, D-Md., who represents the suburbs where the FDA headquarters are located. “You have my promise that if confirmed, I will do my own independent assessment on personnel.”
But he also hinted that current staffing levels may not be maintained because of a large expansion in FDA staff, which now number around 19,000.
“I understand there were some layoffs recently,” Makary said. “I understand some of many were hired back. But I just wanted to let you know that, to put things in context, we have seen a doubling of the agency in terms of number of employees since 2007.”
However, the user fees collected from drugmakers to support the FDA’s review work have more than tripled since 2007. During that time, new user free structures have also been put in place to speed evaluations of generic and biosimilar drugs.
The agency has also made an effort to hire staff in new areas of technological advancement, such as around artificial intelligence and genetic medicine. Device staff working on AI were among those initially laid off, although it’s unclear whether some have since been rehired.
Sen. Susan Collins, R-Maine, questioned the decision to lay off “probationary” employees, specifically, because of the agency’s need to bring new scientists and researchers in to replace older ones as they retire.
“Ironically, more than half of the FDA employees are funded under various industry user fee agreements, so there is revenue coming into the FDA to pay for these employees,” Collins said. “If confirmed, will you — not an outside force but you — have full authority over FDA staffing decisions?”
Sen. Tim Kaine, D-Va., objected to how the layoffs were made as broad decisions, such as by going after the probationary employees who have fewer protections. “If you look at this going forward, do you think personnel policy, including layoffs, should be done strategically, rather than just kind of willy nilly across the board?” Kaine asked.
“I’m a surgeon, so, you know, I’m going to give you a surgical answer,” Makary answered.
Drugmakers and their lobbying organizations have for the most part been quiet on layoffs at the agency, even as the cuts included staff doing work that companies helped fund through fees.
John Crowley, head of the trade group BIO, recently warned against continuing with haphazard layoffs in an op-ed in Stat, however. “Some of the administration’s recent efforts to reform the federal government through aggressive and often indiscriminate personnel cuts have lacked the strategic insights necessary to modernize and reform our nation’s health care agencies, especially the FDA,” he wrote.
Investors, noted RBC Capital Markets analyst Brian Abrahams, remain cautious about the “risk of FDA attrition” and the “disruption this could bring to the review processes and recent flexibility.”
Ned Pagliarulo contributed writing.
