Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs
Peter Doshi, BMJ, July 1, 2024
During his final three years at the US Food and Drug Administration the physician scientist Doran Fink’s work focused on reviewing covid-19 vaccines. But a decade after joining the agency Fink had accepted a job with Moderna, the covid vaccine manufacturer, and was undergoing mandatory FDA exit requirements. As he left for the private sector, the FDA’s ethics programme staff emailed him guidelines on post-employment restrictions, “tailored to your situation.”
The email, obtained by The BMJ under a freedom of information request, explained that, although US law prohibits a variety of types of lobbying contact, “they do not prohibit the former employee from other activities, including working ‘behind the scenes.’”
The legal ability to work “behind the scenes” is enshrined in federal regulations and highlights a “critical, critical loophole” in US revolving door policy, says a leading consumer advocate. Craig Holman, a government affairs lobbyist for the organisation Public Citizen, told The BMJ that the rules forbid various forms of direct lobbying contact but permit lobbying activity that is indirect.
“So, people will leave government service and can immediately start doing influence peddling and lobbying,” Holman explained. “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.”
Diana Zuckerman, president of the non-profit National Center for Health Research and a decades long regulatory policy analyst, was surprised to learn of the FDA’s advice. “I guess I had this vision that they actually had meaningful restrictions on what people could do for at least a year” after federal service, she said. Advice given behind the scenes, Zuckerman argues, is precisely “what makes FDA scientists and staff valuable.”
The documents obtained by The BMJ show that the FDA’s advice regarding work done “behind the scenes” was not limited to a single email but appeared several times in emails to Fink and in emails to Jaya Goswami, an FDA medical officer who reviewed Moderna’s covid vaccine before leaving for a position with the manufacturer
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The FDA’s guidance seems to be part of the standard boilerplate advice sent to employees by FDA staff responsible for ethical compliance. It has also been included, since June 2017, on an FDA web page detailing post-employment restrictions.4
Zuckerman finds FDA’s proactive provision of advice on behind-the-scenes work particularly troubling. “I just think that this is the key to the revolving door … It’s one thing to know it happens, and it’s another thing to know that the [FDA] ethics folks are saying, ‘Don’t worry, you can do this.’”
Peter Lurie, president of the Center for Science in the Public Interest in Washington, DC, and former associate commissioner at the FDA, suspects that in providing employees with advice on behind-the-scenes work the FDA ethics staff were simply carrying out their proper function. “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,” he says.
But Lurie 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. 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.”
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Last month US lawmakers introduced bills to amend the law regulating restrictions on departing employees. Both bills 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.
To read the original BMJ article with footnotes and additional information, click here.
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