From the Daily Caller News Foundation

By Emily Kopp

Ten of the twelve former Food and Drug Administration (FDA) commissioners and acting commissioners opposed to the Trump administration’s stiffer standards for vaccines quietly disclosed ties to the pharmaceutical industry, a Daily Caller News Foundation review shows.

The FDA old guard criticized the new leadership in a Dec. 3 New England Journal of Medicine (NEJM) letter over a higher regulatory bar for vaccines, namely the expectation that most new vaccine approvals will require randomized clinical trials, arguing it could hamper the market.

“Insisting on long, expensive outcomes studies for every updated formulation would delay the arrival of better-matched vaccines when new outbreaks emerge or when additional groups of patients could benefit,” the former commissioners wrote. “Abandoning the existing methods won’t ‘elevate vaccine science’ … It will subject vaccines to a substantially higher and more subjective approval bar.”

But while the former commissioners disclosed their conflicts of interest to the medical journal — per standard practice in scientific publishing — reporters didn’t relay them to the broader public in reports in the Washington Post, STAT News and CNN.

The headlines about a bipartisan rebuke from former occupants of FDA’s highest office give the impression that the Trump administration is contravening established science, but closer inspection reveals a revolving door between pharmaceutical corporations and the agencies overseeing them.

Three of the signatories have received payments totaling $6 million from manufacturers or former manufacturers of COVID vaccines.

Scott Gottlieb has received $2.1 million in cash and stock from his position on the Pfizer board of directors, where he has advised on ethics and regulatory compliance since 2019, according to company filings to the Securities and Exchange Commission. Stephen Ostroff has received $752,310 from Pfizer in consulting fees since 2020, according to OpenPayments.

Mark McClellan has received $3.3 million from Johnson & Johnson as a member of the board of directors since 2013, SEC filings also show. McClellan also consults for the new pharmaceutical arm of the alternative investment management company Blackstone, which invested $750 million in Moderna in April 2025.

Gottlieb and McClellan did not respond to requests for comment. Ostroff could not be reached for comment.

FDA Center for Biologics Evaluation and Research Director Vinay Prasad outlined the higher standards and shared the results of an internal analysis validating 10 reports of children’s deaths following the COVID-19 vaccine in a Nov. 28 memo to staff. He called for introspection and reform at the agency.

The NEJM letter criticizes Prasad for cracking down on a practice called “immunobridging” that infers vaccine efficacy from laboratory tests rather than assessing it through real-world reductions in disease or death. The FDA under the Biden administration expanded COVID vaccines to children using this “immunobridging” technique, extrapolating vaccine efficacy from adults to children based on antibody levels.

Norman Sharpless — who in addition to previously serving as acting FDA commissioner also served as the head of the National Institutes of Health’s National Cancer Institute — consults for Tempus, a company that collaborates with COVID vaccine maker BioNTech. He has helped steer $70 million in investments in biotech through a venture capital firm he founded in November 2024. Sharpless also disclosed $26,180 in payments in 2024 from Chugai Pharmaceutical, a Japanese pharmaceutical company that markets mRNA technology among other drugs, on OpenPayments.

“I was grateful for the opportunity to serve as NCI Director and Acting FDA Commissioner in the first Trump Administration, and strongly support many of the things President Trump is trying to do in the current Administration,” Sharpless said in an email.

Margaret Hamburg, another former FDA commissioner and signatory of the NEJM letter, has since 2020 earned $2.8 million as a member of the board of Alnylam Pharmaceuticals, which markets RNA interference (RNAi) technology.

Hamburg did not respond to a message on LinkedIn.

Most signatories disclosed income from biotech companies testing experimental cancer treatments. These products could face tighter scrutiny under Prasad, a hematologist-oncologist long wary of rubberstamping pricey oncology drugs — which Prasad points out often cause some toxicity — without plausible evidence of an improvement in quality of life or survival.

The former FDA commissioners disclosed ties to Sermonix Pharmaceuticals Inc.; OncoNano Medicine; incyclix; Nucleus Radiopharma; and N-Power, a contractor that runs oncology clinical trials.

Andrew von Eschenbach, who like Sharpless formerly served both as FDA commissioner and the head of the National Cancer Institute, disclosed stock in HistoSonics, a company with investments from Bezos Expeditions and Thiel Bio seeking FDA approval for ultrasound technology targeted at tumors.

Some FDA commissioners who signed onto the letter opposing changes to vaccine approvals have ties to biotechnology investment firms, namely McClellan, who consults Arsenal Capital; Janet Woodcock, who consults RA Capital Management; and Robert Califf, who owns stock in Population Health Partners.

Califf did not respond to an email requesting comment. Woodcock did not respond to requests for comment sent to two medical research advocacy groups with Woodcock on the board. Eschenbach did not respond to a LinkedIn message.

The two signatories without pharmaceutical ties may find their judgement challenged by the FDA investigation into COVID-19 vaccine deaths, having either implemented or formally defended the Biden administration’s headlong expansion of vaccines and boosters to healthy adults and children.

David Kessler executed Biden’s vaccination policy as chief science officer at the Department of Health and Human Services, helping to secure deals for shots with Pfizer and Moderna.

Meanwhile Jane Henney chaired a National Academies of Sciences, Engineering, and Medicine report published in October 2025 that praised the performance of FDA and Centers for Disease Control and Prevention (CDC) vaccine surveillance during the pandemic — underwritten with CDC funding.

That assessment clashes with that of a Senate report, citing internal documents from FDA, finding that CDC never updated its vaccine surveillance tool “V-Safe” to include cardiac symptoms, despite naming myocarditis as a potential adverse event by October 2020, and that top officials in the Biden administration delayed warning pediatricians and other providers about the risk of myocarditis after their approval in some children in May 2021, months after Israeli health officials first detected it in February 2021. The Senate investigation named Woodcock, a signatory of the NEJM letter, as one of the FDA officials who slow-walked the warning.