US FDA’s newly appointed drugs chief set to retire
Sign up now: Get ST's newsletters delivered to your inbox
The US Food and Drug Administration’s drug evaluation chief Richard Pazdur is set to retire weeks after taking the role.
PHOTO: REUTERS
Follow topic:
WASHINGTON – The US Food and Drug Administration’s drug evaluation chief Richard Pazdur is set to retire just weeks after taking the new role, a spokesperson for the health regulator said on Dec 2.
Dr Pazdur, the agency’s veteran oncology chief, took over the role on Nov 11, replacing Mr George Tidmarsh after he resigned amid serious concerns about his personal conduct.
“We respect Dr Pazdur’s decision to retire and honour his 26 years of distinguished service at the FDA,” the spokesperson said in a statement.
A federal health official confirmed that Dr Pazdur’s departure is imminent, refuting earlier media reports that he could retract his resignation paperwork.
The latest high-profile departure comes as US Health Secretary Robert F. Kennedy Jr. makes stark changes at the agency. Longtime FDA vaccine chief Peter Marks was ousted in April and replaced by Dr Vinay Prasad, an ally of FDA Commissioner Marty Makary.
Days after taking over the new role, Dr Pazdur had questioned a new fast-approval path created by Dr Makary, warning it could pose a risk to public health and be illegal, according to a Washington Post report.
Concerns about the legality of the drug review programme, Dr Makary and Dr Prasad inserting themselves into drug review decisions, and Dr Makary’s efforts to handpick hires for CDER (the Center for Drug Evaluation and Research) contributed to Dr Pazdur’s decision to leave, STAT News reported earlier in the day, citing sources.
“He is one of the most effective and creative regulators in FDA history. With so much attrition already, we’re left with a team with very little experience making major decisions,” former FDA Commissioner Robert Califf said about the move.
According to RBC Capital Markets analysts, Dr Pazdur’s rapid departure is “likely to feed perceptions of internal turmoil at the FDA, adding uncertainty for the biotech sector.”
Dr Pazdur joined the FDA in 1999 and was named director of the Office of Oncology Drug Products in 2005. He has been credited with speeding the review process for dozens of cancer drugs. REUTERS
