Practice highlights “critical loophole” in the revolving door between the FDA and industry
The US Food and Drug Administration (FDA) tells staff leaving for industry jobs that, despite restrictions on post-employment lobbying, they are still permitted to influence the agency, reveals an investigation by The BMJ today.
Internal emails, obtained under a freedom of information request, show how two FDA officials who worked on covid-19 vaccine approvals were proactively informed by FDA ethics staff about their ability to indirectly lobby the agency as they left for jobs with Moderna.
The record shows that since 2000 every FDA commissioner, the agency’s highest position, has gone on to work for industry.
“So, people will leave government service and can immediately start doing influence peddling and lobbying,” explained Craig Holman, a government affairs lobbyist for the organisation Public Citizen. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make contact with their former officials—and that’s exactly the advice that’s being given here.”
Diana Zuckerman, president of the non-profit National Center for Health Research and a decades long regulatory policy analyst, finds FDA’s proactive provision of advice on behind-the-scenes work particularly troubling. Advice given behind the scenes is precisely “what makes FDA scientists and staff valuable,” she argues.
Peter Lurie, president of the Center for Science in the Public Interest in Washington, DC, and former associate commissioner at the FDA, suspects that FDA ethics staff were simply carrying out their proper function, but he expressed concern over the perils of allowing behind-the-scenes work.
“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,” he said. “As a practical matter, this policy likely plays out in a way that advances the interests of big pharma, as that’s where many officials head after FDA.”
The BMJ asked the FDA whether it had any concerns that proactively informing employees about their ability to work behind the scenes could be interpreted as encouraging former FDA staff indirectly to lobby the agency.
An agency spokesperson responded: “No. Working behind the scenes does not necessarily equate to direct or indirect lobbying activities. Lobbying activities are governed by the Lobbying Disclosure Act. Former employees would need to adhere to these requirements, just like any other individual or organization.”
Last month US lawmakers introduced bills to amend the law regulating restrictions on departing employees. They seek to prohibit former health sector employees from serving on the boards of manufacturers of drugs, biological products, or devices after public service. So far, none of the bills have passed.
[Ends]
02/07/2024
Notes for editors
Investigation: Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs doi: 10.1136/bmj.q1418
Journal: The BMJ
Funding: BMJ Investigations Unit
Link to Academy of Medical Sciences press release labelling system:
http://press.psprings.co.uk/
Externally peer reviewed? No
Evidence type: Investigation
Subject: FDA lobbying
