By Josh Nathan-Kazis
When the Food and Drug Administration said last month that Dr. Richard Pazdur, a long-tenured, widely-respected FDA leader, would lead the agency's drug review division, it seemed a sign that things were finally getting back to normal.
That sign seems to have been pointed in the wrong direction.
As of Wednesday night, Pazdur has made plans to retire, and has been replaced by a close ally of FDA commissioner Dr. Marty Makary, who shares Makary's roots as a pandemic-era critic of Covid-19 vaccine policies.
Rather than a return towards status quo at FDA, it seems as though the federal health agencies under the control of Health and Human Services Secretary Robert F. Kennedy Jr., a leading vaccine skeptic, are making a new, concerted push to fulfill the secretary's ideological aims.
The SPDR S&P Biotech ETF was up 1% at midmorning on Thursday after falling in early trading, while the iShares Biotechnology ETF was up 0.1%.
The new acting director of the FDA's Center for Drug Evaluation and Research, Dr. Tracy Beth Høeg, has been working as a political appointee at the agency since March, and has been a prominent figure in efforts to change U.S. vaccine policy.
Høeg has been at the forefront of efforts within the FDA to change how the agency approaches vaccines. On Thursday morning, she was participating in a meeting of the Centers for Disease Control and Prevention's vaccines advisory committee, at which she said that studies supporting the safety of the existing hepatitis B vaccines of are low quality. "We have very limited confidence in what we say when we say these vaccines are safe," she said.
A review of hepatitis B vaccine research published earlier this week by the Vaccine Integrity Project said that studies "consistently demonstrate" that the vaccine is safe.
A widely-circulated memo that another top FDA leader, Dr. Vinay Prasad, sent to agency staff on Friday and announced plans to tighten standards for vaccine approvals cited work by Høeg that Prasad says led FDA staff to conclude that the Covid-19 vaccine had led to the deaths of at least 10 children.
Høeg's appointment, and Prasad's memo, together extinguish any notion that Kennedy's campaign to remake the FDA is easing up. Biotech stocks have been rising this fall, and the SPDR S&P Biotech ETF was up 8.9% from Pazdur's appointment on November 11 to the day before his resignation on Dec. 1, a period in which the S&P 500 was roughly flat.
Pazdur's departure, first reported on Monday, has kicked off an unusual degree of public consternation among industry officials and former regulators. Late Wednesday, the New England Journal of Medicine published an article signed by a dozen former commissioners and acting commissioners of the FDA which criticized Prasad's vaccine memo, and the assertion in the memo that the Covid-19 vaccine had led to the deaths of 10 children.
"Previously, all the cases reported to the Centers for Disease Control and Prevention $(CDC)$ and to the FDA had been carefully reviewed by FDA staff, who drew different conclusions," the commissioners wrote. "The memo offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation."
The commissioners said that Prasad's proposal to change how vaccines are approved in the U.S. are a "major shift" in how the FDA works, and "misrepresent both the science and the regulatory record, especially in the case of vaccines that target well-understood pathogens through an established mechanism of action."
The FDA did not immediately respond to a Barron's request for comment on the NEJM article by the former commissioners.
Prasad suggested in his memo that the agency will do away with the practice of relying on studies that measure a recipient's immune response to a vaccine, rather than measuring clinical outcomes. The former commissioners condemned the proposed change.
"If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes; it would also suppress innovation and competition," the commissioners wrote. "The net effect would be to disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections."
The turmoil at FDA came as outside advisers to the Centers for Disease Control and Prevention met Thursday to consider changes to the CDC's hepatitis B vaccine guidelines for newborns.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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(END) Dow Jones Newswires
December 04, 2025 11:13 ET (16:13 GMT)
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