Ex-CDER chief Cavazzoni rejoins Pfizer as CMO

In a move that will raise eyebrows in Washington, Pfizer has hired the former director of the FDA's Center for Drug Evaluation and Research (CDER), Patricia Cavazzoni, as its new chief medical officer.

Cavazzoni – who resigned just ahead of Donald Trump's return to the presidency – is rejoining the company she left to take up the role at the federal agency in 2018. Still, the decision to make such a high-profile appointment will do little to staunch criticism by the Trump administration of the 'revolving door' between the pharma industry and the FDA, which some claim can lead to bias in public health decisions.

A May 2024 report published in the British Medical Journal (BMJ) highlighted that nine of the FDA’s past 10 Commissioners went on to work for the drug industry or serve on the board of a drug company.

Robert Califf, who held the job under President Obama, took a role at Verily Life Sciences before rejoining the agency under President Biden, while former Trump pick Scott Gottlieb is now on the board at Pfizer. And new Health and Human Services (HHS) Secretary Robert F Kennedy Jr has gone on record to say he intends to identify and block conflicts of interest at federal agencies.

The decision to appoint Cavazzoni has been sharply criticised by the consumer advocacy group Public Citizen. Dr Robert Steinbrook, director of the organisation's health research group, said that the appointment is "totally unsurprising" and "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."

Pfizer said that Cavazzoni will lead the group's regulatory, pharmacovigilance, safety, epidemiology, and medical information and evidence generation, among other medical functions, and will report to R&D chief Chris Boshoff. She succeeds Aida Habtezion, who is leaving the company.

"Dr Cavazzoni is a world-class developer of medicines across a wide range of therapeutic modalities and has more than 25 years of experience in clinical development, pharmacovigilance, clinical operations, regulatory affairs, safety risk management, pharmacovigilance, epidemiology, and R&D strategy," said Pfizer in its statement on the appointment.

Vinay Prasad, a public health researcher at UCSF who has been pitching for a role in Kennedy's department, possibly as surgeon general, said in a blog post that Cavazzoni's move "is the core rot in American regulation," and is behaviour that is "abhorrent, and […] should be criminal."

He added: "Mr Kennedy has vowed to stop this, and I welcome that. Until it happens, American medicine labours under a curse: we cannot trust our drug regulators to act in the public’s interest. Instead, they too often are acting in their own."