FDA Impacted by the Larger Transition: Some More Q&A
Q: There are a lot of articles, presentations, and analysis about the FDA under the incoming Trump Administration. Can they be relied upon?
A: No. What comes next for FDA is largely–maybe completely–unknown. Since it’s early in the transition process, this is true for most government agencies and most policy positions. Even the announcement of nominees doesn’t provide all that much clarity–past statements are not necessarily predictions of future actions.
Undoubtedly, some of what is being said will prove true. But what we are hearing now are commentators and analysts engaging in speculation. Truly, no harm in that–but we need to call it what it is.
Q: Does what happened to FDA in Trump I provide any useful insight into how the agency might fare in Trump II?
A: Maybe a little, but not much. I would be particularly wary of general comparisons to 2017. Second Presidential terms are always informed by the lessons of the first term–and a desire to push well beyond that experience.
President Trump and his advisors have had four years to think about what they might want to do differently this time. This accounts for the unusually quick announcements of cabinet officers and what seems like a rather fearless attitude about unconventional choices.
Q: What might it mean for FDA that President Trump intends to nominate Robert F. Kennedy, Jr. as Secretary of Health and Human Services?
A: Mr. Kennedy has been more interested and quite a lot more outspoken about FDA (and NIH, too) than his predecessors as HHS Secretary. His remarks certainly lend themselves to the assumption the agency’s work and policies would be under intense scrutiny should he be confirmed by the Senate as Secretary of HHS. As widely reported, his comments have created quite a bit of angst among FDA employees looking for some indication of whether their work will be appreciated and valued.
In practice, we have no idea what any of that means, now or in the future. There can be a big difference between being the outsider speaking publicly about their point of view and being the leader on the inside who can decide next steps within a wide (but not unlimited) scope of possible actions.
The Senate confirmation process itself plays a role–few nominees emerge without having made at least a promise or two that restricts their future positions or actions.
Q: What will it mean for FDA that U.S. Senator Cassidy will Chair the Senate HELP Committee?
A: Senator Cassidy is a physician. Over the last decade, he has worked with a number of health and FDA stakeholders on legislation. Such a respected voice is a welcomed one. He will be a critical player in ensuring FDA is not given major new responsibilities that are unlikely to be funded.
The jurisdiction of the Senate HELP Committee includes HHS and FDA, with responsibilities that include the confirmation hearings for presidential nominees to serve as HHS Secretary and FDA Commissioner. In addition to many other policy areas, the user fee renewal cycle is coming and will go through the Senate HELP Committee.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.