FDA blesses departing COVID vaccine reviewers to influence agency 'behind the scenes' at Moderna

Agency defends practice as lawful, emphasizes ex-employees still subject to 'certain restrictions under the ethics law.' FDA brass already promotes jabs with claims vaccine makers aren't allowed to make.

Published: July 9, 2024 11:00pm

Updated: July 10, 2024 10:06am

David Morens, a senior adviser to then-National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, once told an ally "our FOIA lady" showed him "how to make emails disappear after I am FOIA'd but before the search starts." He's now on administrative leave.

Fauci's former chief of staff, Greg Folkers, appeared to intentionally misspell proper nouns and names likely to be sought in Freedom of Information Act requests related to COVID-19 origins.

No evidence has yet shown the Food and Drug Administration, a sibling to NIAID in the Department of Health and Human Services, is helping its employees evade legally required transparency. 

The FDA simply explains how the employees can continue influencing the agency after they get hired by the companies whose products they regulate.

FOIA productions to University of Maryland pharmacy professor Peter Doshi, which he shared with Just the News, show FDA ethics officers repeatedly telling employees who reviewed Moderna's COVID vaccine, then accepted job offers from Moderna, they can legally work "behind the scenes" – in quotes – to influence the FDA's treatment of their new employer.

Just the News found similar wording in an exemption to a federal law permanently restricting "any former employee's representations to [the] United States concerning particular matter[s] in which the employee participated personally and substantially."

The law states "behind-the-scenes assistance to another person" that doesn't involve "a communication to or an appearance before" a federal employee is exempt. 

June and September 2022 emails from Center for Biologics Evaluation and Research Ethics Program specialist Cherie Jones to supervisors for the departing employees, Jaya Goswami and Doran Fink, claim that Jones is summarizing HHS Office of General Counsel rules, which her office previously sent to all CBER employees in August 2021.

"Please note that some of these bans are specific to the employee personally making representations to a government agency, they may still be permitted to work 'behind‐the‐scenes' advising others on the communication, the employee just could not make any communication personally with the intent to influence," the summary reads. 

Goswami separately received "post‐employment guidance … tailored to your situation" that also expressly lets her work "behind the scenes" regarding "covered matters," in the absence of intent to influence, under the federal ban on "switching sides," also in quotes.

FDA Office of Ethics and Integrity specialist Phillip Kresge told Fink months later he is "not prohibited from working 'behind the scenes' at any time, provided that you do not disclose non‐public information and do not communicate to – or make appearances before – the federal government or its employees."

Doshi, also senior editor at the British Medical Journal, obtained but did not post the emails for a followup report on an earlier BMJ investigation "into the revolving door between the FDA and industry," focusing on Moderna and the Office of Vaccines Research and Review.

National Center for Health Research President Diana Zuckerman told Doshi she was surprised by the FDA's guidance. 

"I guess I had this vision that they actually had meaningful restrictions on what people could do for at least a year" after leaving, because behind-the-scenes help is "what makes FDA scientists and staff valuable," she said. FDA ethics officers proactively telling departing employees "'Don’t worry, you can do this'" is different than employees simply knowing "it happens."

Former FDA Associate Commissioner Peter Lurie, president of the Center for Science in the Public Interest, didn't blame ethics staff but told Doshi "this policy likely plays out in a way that advances the interests of big pharma, as that’s where many officials head after FDA."

"Working behind the scenes does not necessarily equate to direct or indirect lobbying activities," FDA Media Relations Director Jeremy Kahn told Just the News, pointing to the "behind-the-scenes assistance" provision in federal law.

"Lobbying activities are governed by the Lobbying Disclosure Act," he wrote in an email. "Former employees would need to adhere to these requirements, just like any other individual or organization."

The "off-boarding" process for departing employees "includes the optional opportunity to disclose information about their plans after FDA employment, which may include the identity of prospective employer, if applicable," Kahn said, though the agency "does not currently have a mechanism to confirm if post-government employment was obtained and where."

He said the Office of Ethics and Integrity "encourages employees to seek ethics guidance after their separation from FDA because they continue to remain subject to certain restrictions under the ethics law," including a "criminal conflict of interest statute."

Kahn told Doshi for the previous investigation that the FDA has "more enhanced ethics restrictions than most other federal agencies."

Makers of COVID therapeutics don't have to hire their former regulators to get favorable treatment under current agency leadership, however.

Commissioner Robert Califf has repeatedly promoted claims that are not FDA claims to promote increased vaccination and booster rates, including that people who didn't get an updated Pfizer vaccine "appeared to be unprotected" and that vaccinated children are less likely to develop so-called long COVID.

Manufacturers are prohibited from making such unvetted claims, former Office of Vaccines Research and Review Deputy Director Philip Krause recently told Congress. Though he couldn't explain why the FDA didn't stop Pfizer from running an ad with celebrity cooking host Martha Stewart claiming its booster "help[s] protect against recent Omicron variants" without evidence.

FDA press officer Cherie Duvall-Jones acknowledged receipt but did not answer a Just the News query on whether the agency ever took action against Pfizer, even a warning, for making that claim or if the company is allowed to make claims without FDA-reviewed data.

Krause and his boss, Marion Gruber, fought the agency's "hyper-accelerated" schedule to fully approve Pfizer's vaccine in summer 2021, demanded by CBER Director Peter Marks – himself known for making unvetted COVID claims on social media – and then-Commissioner Janet Woodcock so the Biden administration could mandate it.

Former White House COVID-19 Response Coordinator Ashish Jha recently conceded that COVID vaccine mandates, which he supported, "in the long run ... bred a lot of distrust and I think was harmful," even as he insisted that mandates "saved a lot of lives."

Krause and Gruber resigned after the FDA approved COVID boosters over their objections, though Gruber told Congress she was planning to leave before COVID and Krause had signaled his exit after getting sidelined in the full approval of Pfizer's vaccine.

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