In one of the first appearances since the election of DONALD TRUMP, current FDA Commissioner ROBERT CALIFF weighed in on issues from staffing to final policy priorities at a cancer-focused workshop. AgencyIQ has the highlights.

What Califf said at the Friends of Cancer Research annual meeting

• For now, current FDA Commissioner ROBERT CALIFF will be running the FDA through inauguration day. Once he resigns – whether that is of his own volition or at the request of the new administration once DONALD TRUMP is sworn in as president – an acting commissioner would be chosen. AgencyIQ explains the succession plan in this analysis and discusses post-Presidential inauguration considerations in our analysis here.
• Califf was the morning keynote speaker at the Friends of Cancer Research Annual Meeting on November 12, 2024. The session, moderated by Prevision Policy’s RAMSEY BAGHDADI, represents one of the first appearances made by the FDA leader since Election Day.
• FDA’s current status and staff: Califf provided a positive review of the agency, saying, “I feel like from the FDA perspective,” the agency currently has “all engines on go right now.” AgencyIQ has previously described FDA’s workforce challenges, which have been articulated in its own Strategic Workforce Plan. These issues are felt acutely by its inspections personnel, which the Government Accountability Office (GAO) found faced a 16% vacancy rate this year. Califf provided a different view, saying, “We’re hiring pretty well and not having trouble getting very talented people, and I think we just don’t know what’s going to happen now.” When Baghdadi asked whether he foresees a “mass exodus” at the agency following the election, Califf said, “So I just think we have to wait and see and have some faith that hardworking, high-quality people are going to still be in place.” He continued, “And we’ll have support, I hope, from the external regulated community, which, given the dynamics, is likely to be the most important factor.” [See AgencyIQ analysis: What could the Trump administration mean for FDA’s workforce?]
• The RFK Jr. of it all: Baghdadi asked Califf his thoughts on “the kinds of threats that have been made by people like [Robert F. Kennedy Jr.], saying very specifically that he wants to clear out FDA groups that work in certain categories, like nutrition.” Califf said that back-and-forth discussions on hypotheticals are not productive but acknowledged that food regulation has been a major focus of his second stint as FDA Commissioner. He pointed to a “chronic disease crisis” in the United States stemming from diet, saying, “there is work that needs to be done.” Regarding the agency’s nutrition staff, he made clear, “They are really hardworking people, and they’re limited in what they can change by the laws that Congress passes.” [See AgencyIQ analysis: How could Robert F. Kennedy Jr. influence the FDA?]
• Qualities of the next FDA Commissioner:  Califf explained that the “ability to function as an executive” is a very important quality for this role, which he said means the ability to listen to multiple points of view, learn, and make decisions. In addition, the person should be able to use evidence to make decisions and appropriately recognize expertise. He explained, “…I feel like a lot of what’s in question right now in our society is, should we make decisions based on how we feel at any given moment in time, versus analyzing things and coming up with an opinion…” [See AgencyIQ analysis: How does the process of confirming an FDA commissioner work?]
• The dynamic between HHS and FDA: According to Califf, the vast majority of FDA decisions on individual products are made by career civil servants, with the exceptions of internal dissent or appeals that can be brought to higher levels. However, he made clear that while it did not happen to him, “…it’s totally within the law for the president or the HHS Secretary to overrule the entire FDA and so that could happen.” In Califf’s perspective, the “line between political and scientific” is not always sharp. However, “for individual product decisions where you have high quality evidence, where the criteria is based on ‘survive, feel or function’—the sort of standard criteria for medical products—there is no role for politics there.” [See AgencyIQ analysis: How could the new Trump administration alter the FDA’s relationships with other U.S. federal agencies?]
• The rest of Califf’s term: For medical products, Califf said the work is related to “very significant, relatively technical things,” but spared detail. However, he mentioned several items in the food and tobacco space, including policies related to nicotine standards, food labeling and food packaging.
• More reflections from Califf to come. “You know, I have a whole series of essays I’m going to write when I finish, I’m up to over 90,” he said, noting that multiple relate to FDA’s relationship with the White House Office of Information and Regulatory Affairs (OIRA). “So, to argue that there’s no integration of politics and science, I think, is a mistake, and we’re going to need to talk bluntly about this,” Califf said. Many FDA regulations and high-profile guidance documents first go to OIRA for review and clearance before they’re published, and AgencyIQ expects Trump could reinstate some policies from his first term that required more document types to receive White House review. [See AgencyIQ analysis: How could the Trump administration’s approach to regulation affect the FDA?]

To read other articles in our Trump Transition series,  please see our Table of Contents piece here.

https://home.agencyiq.com/article/00000193-2c36-dda6-afb7-ae7708dc0000