It didn’t take Dr. Richard Pazdur long to see that he wanted out of Marty Makary’s FDA. The 26-year FDA veteran was hired in November to be director of the Center for Drug Evaluation and Research. He resigned in December. Why?

The Wall Street Journal reported:

Dr. Richard Pazdur, a top federal drug regulator, wasn’t on board.
He and lawyers from the Department of Health and Human Services objected to a press release from Food and Drug Administration Commissioner Marty Makary containing a proposal to require only one clinical trial for drug approvals, down from the usual two.
“All of a sudden, I was given a press release with a quotation by myself written in it, and asked to just agree to it,” Pazdur said in an interview with The Wall Street Journal.
Without addressing Pazdur’s concerns, Makary went public with the proposal.
Pazdur said that under Makary, fast-track drug approvals had been politicized in a way he had never experienced in his 26 years at the agency. Past FDA commissioners carefully avoided interfering in individual drug approvals, instead letting the scientific reviewers have sway. “This wall between the commissioner’s office and the review staff has been breached,” Pazdur said.

Just last week, STAT News reported that FDA’s head of the Center for Biologics Evaluation and Research (CBER), Vinay Prasad, overruled the agency’s reviewers when he refused to accept Moderna’s application for a new influenza vaccine. Excerpt from the STAT story:

Prasad has overruled staff multiple times, most notably to restrict Covid-19 vaccines to people over 65 and those with underlying conditions. His penchant for overturning staff decisions, and his removal of at least seven senior leaders, has created an environment that CBER employees described to STAT as “rife with mistrust and paranoia.”

Just two weeks ago, STAT reported that Makary…

“tried to quell staff and external concerns about a controversial new program to fast-track certain drugs. …It has come under fire both internally and externally for allowing political officials to interfere with the drug review process, STAT previously reported.”

Last month, at the J.P. Morgan Healthcare Conference in San Francisco, Dr. Pazdur discussed his concerns about FDA staff. From STAT’s story:

He said he was also deeply troubled by agency staff “being trampled on.” He referred to one individual who was “writing inflammatory emails using the F bomb,” telling center directors and deputy center directors that “they will go after them, that they were going to lose their jobs if they did not play ball.” He would not name that person. …
Pazdur, looking distraught, spoke of an agency crumbling, with leaders making up rules as they went and longtime, experienced staff members leaving after layoffs and perpetual uncertainty left them unable to do their jobs. At different points, he described “chaos” at the agency with staff having gone through “a lot of trauma,” and said “you do not have stability.”

Meantime, read about the “rudderless CDC,” with no fulltime director appointed now in months. As this article points out, that may be exactly what RFK Jr. had in mind to minimize CDC’s role.

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FDA staff “rife with mistrust and paranoia”