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The US Food and Drug Administration is naming an agency veteran to oversee its largest division granting drug approvals in a bid to quell turmoil in the top ranks that has churned under health secretary Robert F Kennedy.
On Tuesday, the FDA told the Financial Times that Richard Pazdur, a 26-year veteran of the agency, would lead its centre for drug evaluation and research. The promotion comes a week after the unit’s former head, George Tidmarsh, abruptly resigned after he was sued by a biotech company for alleged bias.
Since Kennedy brought his “Make America Healthy Again” movement to Washington, upheaval has swirled at the FDA and other health agencies amid disagreements over drug approvals and vaccine policy. Pazdur, an insider who is currently head of the agency’s oncology division, was expected to improve morale and smooth the agency’s relationship with the pharmaceutical industry, sources said.
“He has a track record of success and is an impressive forward-thinking scientist,” said FDA commissioner Marty Makary, who elevated Pazdur.
The departure of Tidmarsh, who was appointed in July, capped months of volatility at the FDA.
FDA official Vinay Prasad left his role in July overseeing the agency’s division for vaccines, only to return days later. Under Kennedy, the FDA has cut staff and undergone “significant organisational restructuring”, including in the drug research division, according to an agency presentation from September. Other staff had left voluntarily, the agency said.
In March, the FDA’s top vaccine official, Peter Marks, quit after attacking the “misinformation and lies” by Kennedy. Marks joined Eli Lilly in October.
As a result of the upheaval, the pharmaceutical industry is worried about drug approval delays. As of November 3, the division has approved 35 novel drugs this year, down from 39 at this point last year and 46 in 2023, according to the FDA’s website. In June, KalVista Pharmaceuticals said the FDA missed a regulatory deadline for one of its drug approvals “due to heavy workload and limited resources” at the FDA.
On November 2, Tidmarsh was sued by Aurinia Pharmaceuticals, which is developing treatments for lupus and other autoimmune diseases. Tidmarsh posted negative comments about one of the company’s FDA-approved drugs on LinkedIn in September, the lawsuit says.
After the post, Aurinia’s stock plummeted more than 20 per cent, wiping out more than $350mn in market value, the company alleged. Its shares rebounded after Tidmarsh left and are now up 71 per cent for the year. Aurinia accused Tidmarsh of a “long-standing personal vendetta” against the company’s chair.
Attempts to reach Tidmarsh for comment were unsuccessful on Tuesday. The court case is ongoing.
Bringing an outsider such as Tidmarsh into the FDA “produced volatility and drama, which is the antithesis of what life science [companies] need”, said Paul Kim, a partner at Kendall Square Policy Strategies, a consultancy.
Pazdur also helped guide the agency’s Covid-19 response, said Anand Shah, an FDA deputy commissioner during President Donald Trump’s first term. “Rick has been embraced by the industry and patients alike,” Shah said. “It should be a tremendous boost for morale” among FDA staffers.
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