We’re at an inflection point for FDA, says BioCentury’s Usdin

The BioCentury Show: Washington Editor Steve Usdin breaks down why this transition is different for FDA from previous ones, and Trump 2.0’s other impacts for biopharma

All presidential transitions with a change of party come with disruption and threats as well as opportunities. But this one, in particular with regard to the implications for FDA, is different from all those Steve Usdin has been covering in his 30-year tenure as Washington editor at BioCentury.

In particular, this is an inflection point for the agency that currently serves as the global gold standard for drug regulation, said Usdin on a special edition of The BioCentury Show covering the ramifications for the biopharma industry of the second Trump administration. 

Usdin has recently outlined the threats and opportunities that the new era presents, and he elaborated further on those in the discussion.

“There are opportunities at FDA to better align regulation with scientific advances, to streamline bureaucracy, to improve the ways it receives external advice and communicates with the public and regulated industry,” said Usdin. He noted that FDA has already taken initial steps that could be transformational, such as on platform approvals, and global reviews that are now limited to oncology. 

A lot is riding on how the new commissioner, presumably nominee Marty Makary, tackles his job, in particular with regard to FDA employees. Whether he “has the interest and ability to protect FDA staff from the depredations of the DOGE and the OMB. Will FDA staff continue to be able to work on a hybrid basis?”

More than that, however, is this unique moment regarding FDA leadership that sets it apart from previous transitions. “We’re at an inflection point, clearly, for several reasons,” said Usdin. One is that there are two center director openings: Patricia Cavazzoni, former head of the Center for Drug Evaluation and Research (CDER), left the agency on the last day of the Biden administration, and Jeff Shuren, left in July as head of the Center for Devices and Radiological Health. Though Peter Marks, head of the Center for Biologics Evaluation and Research (CBER) has said he will stay as long as he can, there are at least two major openings in arguably the most influential positions at a practical level in FDA.

“The center directors are really the people who run the FDA on a day to day basis. They have far more control over the decisions and the policies it makes than the commissioner,” said Usdin. 

Other factors making this time different, he said, are efforts to strip civil servants of their protections and make them more beholden to the White House and to the president.

On the positive side, “this is an inflection point in terms of trying to catch the regulatory system up with the science, and there are possibilities for doing that,” said Usdin. 

Usdin also talked about a key pivot point, which is that negotiations for reauthorizing medical product user fees are scheduled to happen this year, a process that may be jeopardized by Robert F. Kennedy Jr., if confirmed as HHS secretary, because he has expressed opposition to user fees.

“If user fees just go away and aren’t replaced by anything else, it will be a catastrophic blow to FDA’s ability to review drugs,” said Usdin. But again, there’s a big opportunity he noted.

“There’s an opportunity to recast user fees, to reimagine them in ways where industry will still be making large financial contributions to FDA, but it will be more clear that there’s an arm’s length distance, more clear to the public anyway.” There may be ways to leverage this process to create more streamlining and efficiency at FDA.

Usdin also talked about the impact of changes at FTC, where he sees legislation around China going, and what might and might not be expected to change with the Inflation Reduction Act.