Turmoil and tensions at FDA after dramatic exit of top drug regulator | Trump administration

A.Following the dramatic firing of the U.S. Food and Drug Administration’s (FDA) top drug regulator two weeks ago, officials scrambled to find a replacement in a process that exposed the agency’s internal fissures and tensions.

This is disturbing news for a regulator previously known for its stability and consistency.

On Tuesday, the U.S. Department of Health and Human Services (HHS) announced that the top spot at the Center for Drug Evaluation and Research (CDER) will be filled by a surprising candidate.

Richard Pazdur is a respected oncologist and long-time FDA employee; That’s not the surprising part. However, he reportedly turned down the position when approached last week. based on To the Pink Page. That’s when top leaders started looking for other candidates.

“This is mind-boggling,” said Peter Lurie, president of the Center for Science in the Public Interest and a former commissioner of the FDA. “Flashback after flashback.”

The news comes after several upheavals at the FDA.

George Tidmarsh, who was appointed director of CDER in late July, resigned in early November following accusations of retaliation against a former pharmaceutical business partner and reports of infighting within the organization. Tidmarsh was accused of using his position to harm his former business partner in an explosive case.

He said Tidmarsh opposed a new form of fast-track confirmation in the days before his dismissal. Statistics News. The new program, called the “Commissioner’s National Priority Voucher”, promised rapid review of drugs; but Tidmarsh said he questioned the legality of the plan.

Tidmarsh also reportedly donated with Vinay Prasad, who is also the agency’s chief medical and scientific officer and director of the Center for Biological Evaluation and Research (CBER), after Prasad repeatedly bypassed Tidmarsh to ask CDER employees to do work for him.

HHS did not respond to the Guardian’s questions about the power struggles between Tidmarsh and Prasad, but the agency confirmed Tidmarsh was no longer working there.

“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” press secretary Emily Hilliard said.

Prasad himself also suffered flashbacks. He was forced to resign in July but unexpectedly returned less than a week later. FDA chief Marty Makary is reportedly working to bring it back.

Lurie said, “Prasad has clearly been very aggressive and the experience of being fired hasn’t softened him — if anything, he seems to feel like he has the wind at his back now that he’s back to his old self.” “But none of this speaks well to the type of relationships between center managers that are necessary to keep the center functioning.”

Lurie said the degree of disagreement among top FDA officials was “very unusual.”

Before the position was filled by Pazdur, a CDER employee told the Guardian that “I would never accept it” because the position would be “career-killer” in terms of turmoil and turnover at the agency.

“Also, I would have Vinay Prasad complaining endlessly to me or about me,” said the employee, who requested anonymity to protect his job.

Following Tidmarsh’s departure, several long-time employees Negative relating to Sara Brenner, the FDA’s deputy commissioner, sent an email to some CDER employees on Friday asking if anyone wanted to apply.

“The entire appointment process at the FDA under the current administration has been a huge departure from accepted practices,” Lurie said. “It’s really hard to overstate the degree of confusion in the agency, and it makes people in the agency nervous.”

He said opening the position to so many employees “smells of desperation” and gives the impression that FDA leaders are having a hard time filling the job. But Lurie added that Pazdur has the “right qualifications” and that choosing someone from the FDA could boost confidence and morale.

“There’s a sense among people who have worked at the agency for a while that they are under siege by people from the outside who have only a limited understanding of the way the FDA works, and that they would be better served by someone who truly understands the agency,” he said.

Lurie notes that the pharmaceutical industry values ​​stability at the FDA above all else. There is a fundamental belief within the industry and the public that FDA review is valuable for maintaining trust and safety. “What they really want is day-to-day predictability, otherwise everything is going to fall apart,” Lurie said.

The FDA has developed careful and relatively uncontroversial processes for decades to evaluate drugs, biological products, and medical devices.

“But now it’s all up for grabs,” Lurie said. “Suddenly, we have people who can review their medications in a one-day meeting.”

Lurie said the chaos at the FDA, in addition to disrupting its regulatory work, could undermine the credibility of its experts generally, especially as senior officials in the administration continue to attack scientific expertise.

“If the attack on the government continues at this pace, the idea that the government cannot be trusted may actually come true,” he said.