FDA in turmoil after exit of veteran cancer researcher
Story by Sarah Owermohle, Adam Cancryn, CNN, December 5, 2025
Food and Drug Administration Commissioner Marty Makary is under renewed scrutiny by Trump officials amid continued turmoil at the agency, including a series of high-profile departures that have raised questions in the administration about Makary’s ability to lead, according to two people familiar with conversations.
The pending exit of Dr. Richard Pazdur, a veteran researcher who pioneered the FDA’s approach to cancer treatments, has caused the most concern, sources say. Pazdur plans to retire this month just weeks after accepting a role heading the FDA’s largest division overseeing prescription drugs, over-the-counter medicines and pharmacy staples.
Pazdur’s departure comes amid wider clashes with FDA top brass over who should lead the agency’s key departments, and how to balance sped-up drug reviews with quality control, according to three people familiar with the dynamics within the agency.
Pazdur’s breaking point happened when Makary pressed him to replace career drug regulators with his own hand-selected hires, those people said.
Makary up to now has been a close personal ally of Health and Human Services Secretary Robert F. Kennedy Jr. But Kennedy, who met with Pazdur for an hour on Wednesday, has grown frustrated with the public turmoil, sources say.
Pazdur’s departure has triggered broad concern across the administration, and within the pharmaceutical industry, over the potential that it could destabilize the drug review process and erode confidence in the FDA, widely seen as the world’s gold standard regulators of drugs and vaccines.
Under Kennedy’s leadership, numerous career officials have been ousted at the health department, reshaping the top ranks of regulators and policymakers. In some cases, that has led to dramatic policy changes, including recommendations for childhood vaccines.
Even as White House officials privately bemoan another FDA exit as an embarrassing distraction, some of Kennedy’s hires appeared to poke fun at the turmoil this week at a pivotal meeting to discuss whether to drop the universal hepatitis B vaccination for newborns.
“There’s not much happening at the Food and Drug Administration,” Dr. Robert Malone, vice chair of the Advisory Committee on Immunization Practices, said during a public meeting Thursday as he introduced Pazdur’s replacement, Dr. Tracy Beth Hoeg.
“Do you wish to share any recent events?” Malone asked her before she presented on changes underway to the FDA’s vaccine review process.
“Nothing dramatic or salacious or anything has been happening,” Hoeg appeared to joke.
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FDA in turmoil after exit of veteran cancer researcher
Marty Makary is essentially another influencer or media commentator in this administration. Before his appointment, Makary profited off the vaccine and Covid skepticism.
Trump’s FDA pick made his name by bashing the medical establishment. Soon he may be leading it | AP News |
