Article Summary:
The FDA’s top drug regulator, Rick Pazdur, has submitted his resignation to the agency, according to four people familiar with the decision. Pazdur’s abrupt departure comes just weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval.
Pazdur’s decision to resign raises new questions about Makary’s leadership of the FDA. In recent weeks, Pazdur clashed with Makary over the Commissioner’s National Priority Voucher program, which aims to speed the review of drugs addressing health priorities. The program has also faced criticism from Pazdur’s predecessor, George Tidmarsh.
The FDA has seen significant turnover in its senior leadership this year, with four different leaders in the Center for Drug Evaluation and Research (CDER). Makary’s effort to elevate Pazdur, a longtime cancer drug regulator, was intended to provide much-needed stability to the agency.
The news of Pazdur’s resignation has raised concerns in the pharmaceutical industry, with one lobbyist stating that it would be a “body blow” to the FDA if he truly departs. The White House and Pazdur have not yet commented on the decision.
The FDA has praised Pazdur’s 26 years of distinguished service and his legacy of regulatory innovation, which has shaped the agency and advanced patient care. However, the ongoing turmoil at the agency’s top levels has sparked worries about the stability and direction of the FDA’s oversight of the pharmaceutical industry.