An investigation published in the BMJ on Monday reveals the “revolving door” between the US Food and Drug Administration and the pharmaceutical industry. FDA employees, including high-level officials, often leave the agency to work for pharmaceutical companies, potentially creating conflicts of interest and raising concerns about the influence of industry on regulatory decisions.

Also revealed by the BMJ investigation, from internal emails, is that staff departing the FDA are given guidance on how to lobby for industry without falling foul of US law which prohibits certain lobbying acts.

Emails obtained in response to a Freedom of Information Act request show how the FDA provides guidance to departing employees on how they can work “behind the scenes” for industry after leaving the agency and, despite restrictions on post-employment lobbying, they are still permitted to influence the agency.

The FDA’s ethics staff proactively informed these departing employees that although US law prohibits certain types of lobbying contact “they do not prohibit the former employee from other activities, including working ‘behind the scenes’.”

Senior Editor of the British Medical Journal Reveals Emails From the FDA’s Ethics Dept Allowing Departing Staff to Work “Behind the Scenes” for Moderna

By Naked Emperor

Peter Doshi, Senior Editor at the British Medical Journal (“BMJ”) has once again published an important investigative report. Whilst restrictions are meant to stop former US Food and Drug Administration (“FDA”) staff, who have left to work in private industry, lobbying its former employer, Freedom of Information Act (“FoI”) emails show that the ethics department provides guidance on loop-holes to avoid these.

Doran Fink was an employee at the FDA for over twelve years and as a physician-scientist, he reviewed covid-19 vaccines during the pandemic. In 2023 he moved to Moderna, the very company whose vaccines he had been reviewing, and received guidance from the FDA’s ethics department on his post-employment restrictions.

The BMJ obtained the emails, through FoI requests, which showed that the restrictions had been “tailored to your situation.” Even though there are laws that prohibit lobbying, the ethics department told Fink that “they do not prohibit the former employee from other activities, including working ‘behind the scenes’.”

Craig Holman, a government affairs lobbyist for the organisation Public Citizen, told the BMJ that this was a “critical, critical loophole” in US revolving door policy. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make the contact with their former officials – and that’s exactly the advice that’s being given here.”

Similar advice was given to Jaya Goswami, another FDA officer who reviewed Moderna’s covid vaccine before leaving to work for the company.

Peter Lurie, president of the Centre for Science in the Public Interest in Washington, DC, said “it seems to me that the job of the ethics office is to interpret the law for the outgoing person, and that is what they are doing.” However, the former associate commissioner of the FDA continued that “it does seem contrary to the public interest that an ex-official would be quarterbacking activities behind the scenes, especially for a ‘particular matter’ on which they had worked.”

When the BMJ asked the FDA whether it had any concerns, they said “no, working behind the scenes does not necessarily equate to direct or indirect lobbying activities.”

US lawmakers are now trying to introduce legislation to stop former health sector employees serving on the boards of manufacturers of drugs after public service. One bill is called the Fixing Administrations Unethical Corrupt Influence (“FAUCI”) Act!

The BMJ says that tracking the revolving door is a tricky business, especially for non-senior roles. However, it has been found that a majority of former FDA reviewers take up jobs in the industry and 32% of presidential appointments between 2004 and 2020 to the Department of Health and Human Service, which houses the FDA and Centre for Disease Control (“CDC”), exited to industry after their tenure. Furthermore, since 2000, every FDA commissioner has gone on to work for industry.

Read the whole investigation HERE.

Featured image: British Medical Journal Publishes New Study Titled “Revolving Door Between Government And Industry,” Doctor Shierling, 30 September 2016