FDA in turmoil after exit of veteran cancer researcher

By Sarah Owermohle, Adam Cancryn, CNN

(CNN) — 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.

The CDC advisers voted Friday to abandon hepatitis B vaccinations for newborns.

Makary, meanwhile, was scheduled to meet with White House officials Friday. The meeting was previously scheduled but, coming after Pazdur’s announced departure, took on a new urgency, according to one person familiar with the situation.

Spokesmen for the White House and HHS both denied Friday that Makary’s job was in jeopardy, insisting that senior officials still had full confidence in his leadership and the agency’s agenda.

“The White House maintains complete confidence in Marty Makary and the entire team at HHS and FDA,” White House spokesman Kush Desai said, praising “the near-weekly flow of groundbreaking FDA announcements.”

Turbulence at the FDA

Pazdur’s departure is the latest in a series of upheavals at the FDA this year.

Peter Marks, the vaccine chief who spearheaded Operation Warp Speed during Donald Trump’s first term, left in March and publicly accused HHS Secretary Kennedy of forcing him out. Marks was replaced by Vinay Prasad, a longtime FDA critic who briefly left the agency this summer amid criticisms from Trump “loyalty enforcer” Laura Loomer, only to return weeks later.

The constant turmoil at the FDA has irritated some White House officials in recent months, who have viewed the personnel controversies as an unnecessary nuisance that has distracted from the agency’s policy agenda.

Those concerns peaked in November, in the wake of internal clashes between Prasad and then-top drug regulator George Tidmarsh, who subsequently resigned abruptly amid allegations over his involvement in an extortion scheme.

White House officials at the time briefly discussed sidelining Makary, who had also annoyed Trump officials at times by failing to follow internal policy processes, though they ultimately declined to follow through, two people familiar with the matter said.

Makary quickly found himself in hot water soon after a close adviser, Sanjula Jain-Nagpal, represented herself to some FDA stakeholders as the commissioner’s new deputy chief of staff before the White House had officially signed off on the promotion.

White House officials backed off their push to fire her after determining that the episode had been a misunderstanding, though they have so far denied her the promotion.

Pazdur initially turned down the offer to take over for Tidmarsh as the FDA’s drug director, but was coaxed into it last month after a personal visit from Makary, according to people familiar with the process.

Pazdur insisted on running the division without political interference but quickly became frustrated, according to the three people familiar with his thinking. He also questioned how a sped-up process for reviewing drugs would maintain safety standards.

A memo from Prasad last week outlining new requirements for vaccine approvals raised alarms among some administration officials who were caught off guard by its sweeping overhaul, including its suggestion that the FDA could re-evaluate vaccines already approved.

In his hour-long meeting with Kennedy on Wednesday, Pazdur raised his concerns that Makary’s team was dismantling the drug review process, according to sources familiar with his thinking.

“Kennedy had a conversation with Pazdur to thank him for his service and dedication at the FDA,” according to an HHS spokesperson.

Some Trump officials and allies brushed off the suggestion that Pazdur’s exit would serve as a tipping point, portraying him instead as simply another disgruntled career official who was unsupportive of the Trump administration’s agenda.

In ways, Pazdur’s abrupt departure was “totally expected,” said one former official.

“(I predicted) that this would happen within six months,” the person said. “My only mistake was I didn’t think it was going to happen within six weeks.”

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