After the dramatic ousting of the top drug regulator at the US Food and Drug Administration (FDA) two weeks ago, officials have scrambled to find a replacement in a process that has revealed the agency’s internal cracks and tensions.
It’s troubling news for a regulatory agency that has previously enjoyed a reputation for stability and consistency.
On Tuesday, the US Department of Health and Human Services (HHS) announced the top spot at the Center for Drug Evaluation and Research (CDER) would be filled by a surprising candidate.
Richard Pazdur is a respected oncology expert and longtime FDA employee – that’s not the surprising part. But he reportedly turned down the position when he was approached last week, according to Pink Sheet. That’s when top leaders began searching for other candidates.
“It boggles the mind,” said Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner at the FDA. “Reversals upon reversals.”
The news comes after several upheavals at the FDA.
George Tidmarsh, who was only appointed as CDER director in late July, resigned in early November following accusations of retaliation against a former pharmaceutical business partner and reports of strife within the agency. Tidmarsh was accused, in an explosive lawsuit, of using his position to harm his former business partner.
In the days before his ouster, Tidmarsh had opposed a new form of rapid approval, he told Stat News. The new program, called “Commissioner’s National Priority Voucher”, promised the rapid reviews of drugs – but Tidmarsh said he questioned the legality of the plan.
Tidmarsh also reportedly sparred with Vinay Prasad, simultaneously the agency’s chief medical and scientific officer and the director of the Center for Biologics Evaluation and Research (CBER), after Prasad repeatedly bypassed Tidmarsh to ask CDER employees to do work for him.
The HHS did not respond to the Guardian’s questions about power struggles between Tidmarsh and Prasad, but the agency did confirm that Tidmarsh was no longer employed there.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” said Emily Hilliard, press secretary.
Prasad himself was subject to reversals. He was forced to resign in July, but he returned unexpectedly less than a week later. FDA chief Marty Makary reportedly worked to bring him back.
“Prasad has obviously been very aggressive, and he’s not been softened by the experience of getting fired – if anything he seems to feel that he has the wind at his back because he was restored,” Lurie said. “But none of it speaks well to the kind of relations between the center directors that are necessary to make the place work.”
The degree of discord among top FDA officials is “very unusual”, Lurie said.
Before the job was filled by Pazdur, one CDER employee told the Guardian that “I would never take it” because the position would be a “career killer” in the turnover and tumult at the agency.
“Plus, I’d have Vinay Prasad bitching at me or about me non-stop,” said the employee, who asked for anonymity to protect their job.
After Tidmarsh’s departure, several longtime employees said they were not interested in the position, and Sara Brenner, principal deputy commissioner at the FDA, sent an email on Friday to some CDER employees asking whether any of them wanted to apply.
“The whole process of appointments at FDA in the current administration has been an enormous departure from accepted practices,” Lurie said. “The degree of upheaval at the agency is really difficult to overestimate and leaves people in the agency disconcerted.”
Opening up the position to large numbers of employees “reeks of desperation” and gives the impression that FDA leaders struggled to fill the job, he said. But Pazdur has “the right qualifications”, and choosing an FDA insider might shore up confidence and morale, Lurie added.
“There’s a sense among people who have worked at the agency for a while that they’re under siege by people who have come from the outside with only limited understanding of the way that FDA works and that they would be better served with somebody who actually understands the institution,” he said.
Lurie notes that the pharmaceutical industry values stability at the FDA more than anything. There is a core belief in the industry – and among the public – that FDA review is valuable in order to maintain trust and safety. “Predictability from day to day is really what they want, and otherwise, everything is in upheaval,” Lurie said.
The FDA has developed careful and relatively uncontroversial processes over the decades for evaluating drugs, biologics and medical devices.
“But now, everything is up for grabs,” Lurie said. “Suddenly, we have people who can get their drug reviewed in a one-day meeting.”
In addition to disrupting its regulatory work, the chaos at the FDA may also undermine the credibility of its experts in general, particularly as top officials within the administration continue to attack scientific expertise, Lurie said.
“If the assault on government continues at the pace that it has,” he said, the idea that the government is not to be trusted “could actually become true”.
