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Medical Device and Diagnostics Industry — Outgoing FDA Commissioner Responds to Possible Changes by Trump Administration

Medical Device and Diagnostics Industry — Outgoing FDA Commissioner Responds to Possible Changes by Trump Administration

At a Glance

  • Califf emphasized that the agency is focused on its work, despite uncertainty about the incoming administration’s changes.
  • Robert F. Kennedy Jr. criticized the FDA’s nutrition division, but Califf chose not to engage with his remarks.
  • Califf acknowledged that the new administration is expected to implement significant reforms.

Earlier this month, Robert F. Kennedy Jr. made some rather scathing remarks about FDA – noting that he was going to clean house in the agency when President-Elect Donald Trump takes office. Kennedy has said he could be appointed to a significant role in public health.

Since then, FDA has been quiet about Kennedy’s remarks. However, outgoing FDA Commissioner Robert Califf, MD, addressed the election along with the feeling and mood at the agency regarding the impact of the upcoming administration.

Robert Califf, MD, addressed the election results and Kennedy’s comments during the Friends of Cancer Research Annual Meeting.

“I feel like from the FDA perspective … we’ve got all engines on go right now,” he said during the conference. “We’ve done a massive reorganization. We’ve got very significant plans. We’re hiring pretty well and we’re not having trouble getting very talented people.”

Califf, who is finishing up his second stint as FDA commissioner noted, “I think we just don’t know what’s going to happen now. It’s not correct of me to make any specific comments about what will happen, but I do think it’s pretty clear the gist of this administration from everything that has been said is to change a lot of things. How it gets changed depends on who gets appointed to key positions and how the various policies play out. I also think how the broader regulated industries see things and play into this.”  

“I think we just don’t know what’s going to happen,” Califf said during the meeting. “It’s pretty clear that the gist of this administration, from everything that’s been said, is to change a lot of things, and how it gets changed depends on who gets appointed into key positions and how the various policies play out.”

Kennedy was especially critical of nutrition. In an interview with NBC News’ Vaughn Hillyard, Kennedy said. “In some categories of workers, there are entire departments like the nutrition departments at FDA that have to go. They are not doing their job; they’re not protecting our kids. Why do we have Fruit Loops in this country with 18 or 19 ingredients, while in Canada it has only two or three?”

Califf, when asked at the the conference to respond to some of Kennedey’s more viral comments said, “In my role, it’s best not to respond to those kinds of things because getting into a back-and-forth about hypotheticals is not productive for anyone.”

Califf was also asked to speak about the current vibe and feeling at FDA and whether or not we could see a mass exodus once the new administration takes office.

“I think people are waiting to see,” Califf said. “I think we have to wait and see and have some faith that hardworking and high-quality people are going to still be in place and will have support – I hope, from the external regulated community. I don’t think there’s a lot that people inside FDA can say. What I’ve seen already is people putting their heads down and doing their work.”

https://www.mddionline.com/medical-device-regulations/outgoing-fda-commissioner-responds-to-possible-changes-by-trump-administration