Marks Finds His Next Role as Lilly Snags Another Former FDA Regulator

FDA

Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.

The FDA’s loss is Eli Lilly’s gain. A month after hiring former FDA official Rachael Anatol, Lilly has snagged Peter Marks as senior vice president for molecule discovery and the head of infectious diseases.

Marks, whose abrupt resignation from his post as director of the FDA’s Center for Biologics Evaluation and Research in March sent biotech stocks tumbling, confirmed his new role to STAT News on Tuesday afternoon. His first day at Lilly Research Laboratories was Monday.

“Lilly continually evaluates breakthrough science which could benefit patients,” Stefanie Prodouz, a company spokesperson, told STAT. “Peter’s expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas.”

BioCentury reported the news earlier Tuesday afternoon on X. “I am excited about the potential to help benefit people by advancing the development of vaccines for public health,” Marks told the publication.

Marks’ exit from CBER was controversial. In his resignation letter in March, Marks wrote that he was willing to work to address the concerns of Health Secretary Robert F. Kennedy Jr. regarding vaccine safety and transparency. However, he was ultimately given the choice to resign or be fired after he refused to give Kennedy’s team editing access to the agency’s Vaccines Adverse Event Reporting System (VAERS) for fear that “they’d write over it or erase the whole database,” according to the Associated Press.

STAT noted on Tuesday that Marks’ new role is likely to “rile up” critics of the so-called revolving door between FDA and the pharmaceutical industry. Indeed, Marks’ former FDA counterpart at the Center for Drug Evaluation and Research, Patrizia Cavazzoni, joined Pfizer as chief medical officer in February after exiting the agency in January.

Anatol, who previously served as deputy director of the FDA’s Office of Therapeutic Products, was placed on administrative leave in June, along with OTP Director Nicole Verdun. Capricor Therapeutics CEO Linda Marbán told BioSpace in August that the administrative leave was due to an argument with current CBER director Vinay Prasad about the company’s regulatory application for investigational Duchenne muscular dystrophy cell therapy deramiocel. Anatol joined Lilly in September as associate vice president of global regulatory policy and strategy—genetic medicine.

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