Pazdur to leave FDA, shortly after taking CDER job

Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead the agency's Center for Drug Evaluation and Research (CDER).

Pazdur's departure – first reported by Stat – will leave yet another void at the top of the CDER after previous director George Tidmarsh resigned, after just a few weeks in the role, amid concerns about his personal conduct.

Prasad's predecessor at CBER, Richard Marks, resigned in protest at what he said was a downgrading of scientific principles at the FDA under HHS Secretary Robert F Kennedy Jr.

According to the report, Pazdur told FDA leaders about his intention to retire at a meeting yesterday, and could still change his mind. He was previously head of the FDA's Oncology Center of Excellence (OCE) and has been with the regulator for more than 25 years. Stat said the FDA had confirmed that Pazdur will be standing down.

Pazdur has reportedly already made some waves in his new role, by questioning the new super-fast review framework for medicines deemed to be of national importance, which is being pushed through by FDA Commissioner Marty Makary.

According to the Washington Post, Pazdur had suggested the Commissioner's national priority voucher (CNPV) programme may be illegal.

It is telling that the news of Pazdur's departure weighed heavily on biotech shares, in a week when concerns about the scientific integrity of the FDA under Kennedy was once again under question, albeit on the vaccine side of its affairs regulated by the Center for Biologics Evaluation and Research (CBER).

And it's also worth noting that Vinay Prasad – who abruptly left the top CBER job in July only to return to his role a few days later – has been a vocal critic of Pazdur's oversight of cancer drug regulation in the past.

One eminent biotech figure, former Alnylam chief executive John Maraganore, posted on social media that Pazdur's departure would be "really bad news," adding that he "has been a National Treasure for efforts in bringing safe and effective cancer medicines to patients."

Pazdur has been credited with implementing streamlined processes to speed up the review of novel cancer drugs, allowing them to reach patients more quickly. He was also instrumental in the development and launch of Project Orbis, which allows new drugs to be simultaneously submitted and reviewed by international regulatory agencies.

FDA-focused newsletter The Pink Sheet previously reported that Pazdur had turned down the CDER position when first asked, and only agreed to take the role after Kennedy made assurances that the centre would not be subjected to political pressure.