President-elect Donald Trump on Friday will become the 45th US president, and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.
Since 7 November, FDA has released almost 20 new draft or revised draft guidance documents, some long-awaited, like the one on biosimilar interchangeability, in addition to more than 20 final guidance documents, a measured explanation of off-label marketing, and an interim policy on drug compounding, as well as Thursday’s launch of a new oncology center.
In addition to FDA’s work, Congress in late November rushed through a massive bill that President Barack Obama signed into law in December that also laid out more of the future for FDA and what many critics are saying will lead to lower standards for FDA drug and device approvals, though also new funds for the agency and other public health priorities.
Jacob Sherkow, a New York Law School professor, told Focus last week: “I think, with the new administration, there's going to be a lot of defection from FDA, even with lower-level career positions. I have gotten the impression that, since November, FDA has released a lot of guidances and recommendations because (a) career staff want to wrap up loose ends before they leave; and (b) it's an effort to lock FDA into certain positions concerning safety and efficacy that might be upended by whoever heads the agency next month.”
But other industry observers and the agency itself say that though many of these FDA guidance documents had been lingering for a while (some for more than five years), FDA has a long history of bipartisan support and this push by FDA does not necessarily show that it is trying to prepare for an uppercut from the new administration.
Steven Grossman, deputy executive director of the Alliance
for a Stronger FDA, told Focus that the recent release of new guidances
is not unusual for the end of the year and the only
transition-related aspect is that: “Nobody who has worked for a long time on an over-due regulation is going to welcome the review clock starting over again, especially if the political and policy content is close to zero.” He pointed to
recent guidance documents on biosimilars and drug compounding as examples of overdue
documents that clarify how laws are to be implemented.
FDA’s senior ranks “have
been through transitions before and understand their roles as civil servants is
to carry out the law under the direction of the commissioner,“ Grossman said. Further, he
pointed out, commissioners almost never are involved in any aspect of product
But the push to finish the Cures law during the lame duck period also coincides with Trump's calls for a moratorium on new federal regulations and his consideration of to at least two possible contenders to lead FDA, neither of whom has any medical or clinical research experience.
Either choice, if nominated and approved by the Senate, would be a dramatic departure from FDA’s outgoing commissioner Robert Califf, a former professor of medicine and vice chancellor for clinical and translational research at Duke University, and the founding director of the Duke Clinical Research Institute (in the meantime, Stephen Ostroff will carry on in Califf's place until the Senate confirms a Trump selection).
One of the possible new contenders for FDA commissioner, Balaji Srinivasan, CEO of the bitcoin company 21.co, met with Trump last week, and his Twitter timeline like his potential boss’s, was littered with critiques (though now that timeline has been deleted). Srinivasan, like many who complain of a lack of pharmaceutical innovation, seems to believe FDA is at least part of the cause of this deficiency, and like many before him, his finger was at least momentarily pointed at an easy target: the slow and onerous drug approval process.
But as anyone following FDA and the other pharmaceutical regulators worldwide understands: Regulators are not holding back pharmaceutical or medical device innovation. In fact, FDA, possibly more so than its EU and other international counterparts, willingly and eagerly works with industry and is funded by industry to bring the latest drugs and devices to market in a timely manner, and sometimes, like with the case of Sarepta’s Exondys 51 (eteplirsen), with the support of some members of Congress and against the wishes of some of FDA’s employees.
What's more: any politicizing of FDA and the desire to lower the bar for drug approvals is not new.
Back in the early 1980s, the Reagan administration sought to reform the drug approval process and in 1981, FDA approved more new drugs than in any year since 1962.
When asked in 1988 if a new law requiring Senate confirmation for all new FDA commissioners would hurt the independence of an FDA commissioner, former Democratic Tennessee Senator Al Gore said: “I do not think so. Indeed, I think it would enhance that person’s independence, because instead of being subject to the whim of an immediate superior, he would have the extra insulation afforded by this new role played by a second branch of government.”
How Trump’s FDA commissioner choice deals with this independence and how career staff at FDA deal with this new leader will be crucial for how the approval process changes and what types of new data are used to bring new medical products to market over the next four years.