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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.

AUTHOR

Emily Kopp

Investigative Reporter

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A former senior U.S. Food and Drug Administration (FDA) official hobnobbed with employees from an anti-tobacco nonprofit just months before coming on as the group’s CEO, emails show.

Kathy Crosby, who played a leading role in shaping public health policy while serving as the director of Health Communication and Education at the FDA’s Center for Tobacco Products, became the president and CEO of the Truth Initiative, an anti-tobacco and anti-nicotine activist organization, in August 2023.

Prior to her exit from the FDA, emails obtained by the Functional Government Initiative (FGI) and exclusively shared with the Daily Caller News Foundation show Crosby hobnobbing with Truth Initiative employees and even corresponding with the group’s then CEO about setting up a meeting.

“The emails the Daily Caller showed us raise some serious red flags,” Michael Chamberlain, director of the nonpartisan watchdog group Protect the Public’s Trust, told the DCNF.

“A federal employee is prohibited from accepting gifts, including comped tickets to conferences and galas, that are offered to her because of her status as a federal employee,” Chamberlain said. “That Ms. Crosby appears to have solicited the invitation to the gala she attended compounds the problematic nature of this episode. That she may have leveraged the event as an opportunity to seek outside employment is icing on the cake.”

Federal employees are barred both from soliciting gifts “to be given because of the employee’s official position” as well as from accepting those gifts. Additionally, they are prohibited from using their office for “private gain.” FDA employees are also barred from “seeking or negotiating for employment, that conflict with official Government duties and responsibilities.”

In April 2022, the Campaign for Tobacco-free Kids (CTFK) offered Crosby free tickets to its 2022 gala. Crosby was busy that year, so she declined the tickets but asked CTFK to “keep [her] in mind for next year’s event.”

Roughly a year later, Crosby responded to the same email thread and asked the CTFK if it would be “extending an invitation to any FDA colleagues to attend” the 2023 gala. Hours later, the organization offered Crosby complimentary tickets, which she then accepted, saying that she “should definitely be able to join” them this year.

Emails show that Crosby indeed attended the May 18, 2023, CTFK gala and networked with employees of the Truth Initiative while there.

Shortly after attending CTFK’s gala, Crosby emailed then-Truth Initiative president and CEO Robin Koval on May 22 to schedule a meeting so the two could “catch-up.” In the email, she also mentioned that she had already met with Howard Koh, a member of the organization’s board of directors, and other staff at the gala. Koval and Crosby ultimately agreed to meet on May 24, 2023.

“There’s a reason taxpayers are troubled by incestuous relationships between government agencies and activist groups and public health agencies are proving to be no exception,” Functional Government Initiative spokesperson Peter McGinnis said.

“These activist groups have business before the agencies—we know, for example, that [Trust Initiative] lobbies the FDA to increase fines on tobacco product manufacturers and sellers, while also spending millions to advocate for new product bans,” McGinnis continued. “It’s a coup for [Trust Initiative] to land a CEO who knows her way around the FDA, and it’s a lucrative jump for Ms. Crosby.”

On Aug. 15, 2023, Truth Initiative’s board announced its appointment of Crosby as the group’s president and CEO. Following the announcement, and while Crosby was still at the FDA, multiple Truth Initiative employees reached out via email to congratulate her.

“I just wanted to reach out and send a note to say congratulations,” one email from the group’s vice president of communications, Sarah Shank, reads. “It’s always a pleasure working with you and your team at FDA and I’m beyond thrilled to work with you in this new capacity here at Truth Initiative.”

“So excited for this next chapter with our organization,” Tina Morgan, the organization’s vice president of sponsorships, said.

Truth Initiative and Crosby didn’t respond to requests for comment.

“During Kathy Crosby’s 12 years as the Director for CTP’s Office of Health Communication and Education, she frequently communicated via email, phone calls, and in-person meetings with a wide range of stakeholders, including those from national public health organizations, industry, media, and state/local organizations,” an FDA spokesperson told the DCNF.

Crosby “immediately” notified the FDA that she was looking for a job outside the government and “recused herself from any official actions that would financially impact her future employer,” the spokesperson said, adding that Crosby’s attendance at the gala was also “reviewed and approved by FDA ethics officials” prior to the event.

In 2022, the Truth Initiative was hard at work attempting to influence policy through the FDA and other federal agencies.

According to the nonprofit’s 2022 annual report, they submitted 14 comments to federal agencies, provided “policy analyses and research” to inform FDA policymaking, urged the FDA to act against popular synthetic nicotine products, like ZYN, and recruited youth activists to submit comments to the FDA regarding its proposed rule to remove flavored cigars and menthol cigarettes from the market.

During her time at the FDA, Crosby was involved in crafting health warnings for cigarette packages and advertisements, formulating marketing restrictions for new tobacco products and shaping national policy broadly, according to her Truth Initiative biography.

Crosby spearheaded “public education and regulatory communication programs” which aided the federal government in successfully implementing the Tobacco Control Act, which regulates how tobacco products can be marketed.

AUTHOR

ROBERT SCHMAD

Contributor.

Tag Archive for: revolving door

Former FDA Official Cozied Up To Activists Months Before Joining Them, Emails Show

ROBERT SCHMAD