Elections

The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.

Pink Sheet reporter and editors discuss the uncertainty created by the Trump Administration freezing most communications at the Health and Human Services Department, new travel and telework bans, as well as the delay in announcing an acting FDA leader and the impact of new executive orders on the FDA and CMS.

The cell and gene therapy field has reached an inflection point in the US as the second Trump Administration begins and advocates argue the sector could fit well with the “MAHA” agenda.

The White House is expected to name Sara Brenner, chief medical officer for in vitro diagnostics at CDRH and a veteran of the first Trump administration, as acting commissioner, but the lack of a formal announcement is creating uncertainty. New executive orders on telework and the senior executive service also could impact agency staff.

Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms, comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters, and diverging trends between CDER and CBER novel application approvals.

Robert Califf’s final appearance on Capitol Hill as US FDA commissioner, a 5 December Senate hearing focused on the agency’s food and nutrition functions, was an appropriate coda to his tenure and preview of things to come under the Trump Administration.

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.

6 January 2025 will be remembered in Washington, DC, as the date Congress certified Donald Trump’s second presidential election victory and a snowstorm shut down most of the city, but for FDA watchers it will be the day the agency released more than two dozen new draft and final guidances.

Despite GOP criticism of the Part D stabilization program and its budgetary impact, the Trump Administration may decide to keep it in part to avoid blame for a premium increase.

Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.

Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.

The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.

The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer.

The expected nominee for FDA commissioner has not been very kind to the agency in his public statements and President-elect Donald Trump appears to be urging him to shake things up.

Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.

Numerous staff positions at the US FDA could be the target of incoming administration efforts to remake the federal bureaucracy.

The US FDA’s Peter Marks told the Jefferies meeting that scientific leadership will be protected and that the agency wants to do more to help the sector accelerate innovation.

Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization, as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection to run the US Centers for Medicare and Medicaid Services, could impose if confirmed.

The next round of the negotiation program is scheduled to begin in February unless the new administration delays the start of the process.

Kennedy’s nomination for HHS secretary already is drawing concerns, which could mean a more conventional pick emerges, but industry should prepare for Kennedy to control the US Health and Human Services Department for at least some time.