The agents of chaos seem to have the upper hand at the Food and Drug Administration with longtime FDA staffer Dr. Richard Pazdur announcing his retirement only a month into leading the Center for Drug Evaluation and Research (CDER). It had been hoped that Dr. Pazdur would bring some stability and credibility to the top drug regulator role at FDA.
Dr. Pazdur is the fourth person to lead the Center for Drug Evaluation and Research this year. Simply put, it appears the promises to keep CDER out of the political maelstrom did not materialize. Reports are that concerns about the legality of a new drug review program and politicization of the new voucher program, as well as higher up insertions into drug review decisions and Commissioner Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave. The following day, Theresa Michele, longtime director of the Office of Nonprescription Drugs, was transferred to FDA’s medical devices center.
There have also been reporters of power struggles between FDA and HHS. For healthcare marketers and pharmaceutical companies, it means that politics and feality to the Adminsitratioin have become more of an established norm at FDA, who historically have prided themselves as mostly rising above the fray.
Vaccine Regulation Also in Turmoil
Changes to the ways in which the Food and Drug Administration plans to regulate vaccines represent a threat to effective and available vaccines and public health, 12 former commissioners wrote this week in an editorial in the New England Journal of Medicine.
The changes, as described in a leaked memo by Vinay Prasad, head of FDA’s Center for Biologics Evaluation and Research (CBER), which oversees vaccines, blood products, and gene therapies. The Nov.28 memo sent to the entire staff of CBER saying that agency scientists had identified 10 cases in which the deaths of children were tied to the COVID vaccines made by Pfizer and Moderna. However, detailed evaluations and clinical reports of the 10 cases have not been forthcoming. You can think of this as the FDA’s version of the Epstein files where the lack of transparency is stronger than any conclusions drawn from the reported findings.
And yesterday, the federal vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) again moved to reschedule its vote on delaying the hepatitis B vaccine for the newborns of mothers who aren’t confirmed to have the virus. The panel was originally scheduled to vote on this question of changing the hepatitis B guidance in September, but several ACIP members were confused then over the language of the recommendation and what impact their vote would have on vaccine coverage.
Senate health committee chair Bill Cassidy (R-LA) wrote in a social media post yesterday calling the federal panel of vaccine advisers “totally discredited” just minutes ahead of its meeting Hopefully the FDA gets smarter on its approach.
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