FDA drug chief hints at potential departure as agency chaos intensifies

The United States leading drug regulator indicated on Tuesday that he might step down, just weeks after taking the role, deepening instability at the Food and Drug Administration (FDA). Sources suggest that if Richard Pazdur leaves, identifying a successor could be difficult due to internal conflicts and increasing political pressure.

Who else remains? He was the identified candidate, said Janet Woodcock, former acting FDA commissioner. Many have left, and it will be challenging to find a replacement in the current chaos.

Although filing retirement paperwork is the initial step, Pazdur could still decide to remain with the agency. As a long-time FDA veteran and oncology expert, he was expected to stabilize operations following a year marked by turmoil and tension. He is the fourth head of the Center for Drug Evaluation and Research (CDER) this year and initially declined the role before accepting it at the urging of FDA commissioner Marty Makary.

The prior CDER chief, George Tidmarsh, reportedly departed following a lawsuit alleging retaliation against a former business partner regarding regulatory decisions. Tidmarsh contends he was ousted for questioning a new expedited review system known as the Commissioners National Priority Voucher. He also had conflicts with Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER) and FDA chief medical and scientific officer, who himself briefly left and later returned to the agency over the summer.

There is a lot of internal conflict, Woodcock said. Being asked to manage all of this, while implementing new programs amid a wave of resignations and forced departures, is extremely challenging.

Pazdur was expected to oversee the commissioners new rapid approval initiativea program likened to a Shark Tank for drug approvalsbut planning has been minimal. The idea was that Dr. Prasad and his team would hold a panel and make quick yes-or-no decisions, like Roman gladiators with thumbs up or down, Woodcock explained. Its not a structured process.

Typically, regulatory decisions are made by career officials to avoid political influence. The one-day decision-making sessions have raised concerns about the thorough review and documentation of applications.

Emily Hilliard, spokesperson for the Department of Health and Human Services (HHS), confirmed that Pazdur has submitted retirement paperwork. We respect Dr. Pazdurs decision and honor his 26 years of exemplary service at the FDA, Hilliard said. Pazdur has not commented publicly on his intentions, and it remains possible he may choose to continue in his role. According to Woodcock, filing retirement documents is often a procedural step taken before the start of the new year, leaving the option to remain open.

He may retire, but its not certain yet, Woodcock noted. Given the circumstances, he is certainly considering it seriously.

Uncertainty over leadership at the FDA has lasting implications for public confidence and the future of drug development. The public needs assurance that decisions are consistent, and the pharmaceutical sector requires predictability to justify major investments and risks, Woodcock said.

Author: Chloe Ramirez