By Josh Nathan-Kazis

Pfizer said Monday it hired Dr. Patrizia Cavazzoni, who stepped down from one of the Food and Drug Administration's top jobs just over a month ago, to replace its chief medical officer.

The announcement comes days after the new secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy Jr., said in an address to his staff that he would "shut the revolving door to reestablish public trust" in the department.

Until Jan. 18, Cavazzoni was director of the Center for Drug Evaluation and Research, the division within the FDA that regulates most human medicines and is responsible for the approval of most new drugs.

As CDER director since 2021, Cavazzoni was one of the top FDA officials and perhaps the federal regulator with the most influence over the pharmaceutical industry.

Pfizer said Cavazzoni would join as chief medical officer, replacing Dr. Aida Habtezion, who has been with the company since 2021. Cavazzoni worked at Pfizer earlier in her career, and at Eli Lilly and Sanofi, before going to work at the FDA in 2018.

Pfizer's decision to bring Cavazzoni back into the fold so shortly after her departure from the FDA seems to indicate a lack of concern for Kennedy's promised reforms and a confidence that the business of pharmaceutical regulation will proceed as it did before the Trump era.

Kennedy, a longtime and vociferous critic of the pharmaceutical industry, moderated his message during his Senate confirmation process, particularly on vaccines. Pfizer leadership, for their part, has been notably sanguine about what Kennedy's ascent means for drugmakers.

"My stance is that you need to engage with him," Pfizer CEO Albert Bourla said of Kennedy in an interview with Barron's in early February. Bourla said that he had met with Kennedy. "I told him many times that there are a lot of things that we can do together," he said.

The hiring of Cavazzoni, despite Kennedy's comments on the revolving door, punctuates Bourla's remarks, suggesting the company believes it's still business as usual for drugmakers.

The nonprofit watchdog Public Citizen said Monday that Cavazzoni's return to Pfizer wasn't a surprise.

"Cavazzoni's move demonstrates that the revolving door between the FDA and the industries it regulates is alive and well and continues to undermine the FDA's credibility as a public health agency," Public Citizen's health research group director Dr. Robert Steinbrook said.

A Pfizer spokesperson declined to comment when asked about the revolving door concerns. In a post on LinkedIn, Bourla wrote that Cavazzoni "has extensive experience developing medicines across a range of therapeutic areas and is an ideal leader to help advance our portfolio."

Cavazzoni won't be the only former top FDA official at Pfizer: Dr. Scott Gottlieb, who was FDA commissioner from 2017 through 2019, is a member of the board of directors.

Pfizer shares were up 0.4% at midday Monday, while the S&P 500 was mostly flat.

Cavazzoni maintained a lower profile at the FDA than her predecessor, Dr. Janet Woodcock, a major figure who led CDER off and on from 1994 through 2021. Woodcock was later acting commissioner and principal deputy commissioner of the FDA before her retirement last year.

Cavazzoni received the most public attention of her tenure in mid 2021 when CDER chose to approve Biogen's Alzheimer's drug Aduhelm even after a panel of outside experts advised the FDA that data supporting the drug's efficacy was too weak. Cavazzoni was one of a number of top FDA officials who defended the decision in a medical journal article, saying that patient advocates asked for access to the drug despite uncertainty about its clinical benefit.

The Centers for Medicare and Medicaid Services later refused to pay for Aduhelm for most Medicare patients. The drug has since been discontinued by its manufacturer.

Pfizer said Monday that Cavazzoni will "lead Pfizer's regulatory, pharmacovigilance, safety, epidemiology, and medical information and evidence generation, among other medical functions," in her new role.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

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February 24, 2025 14:04 ET (19:04 GMT)

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