FDA got FOIA’d by the British Med. Journal… Emails reveal ‘ethics’ dept giving guidance to avoid loopholes.

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Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs

Internal emails show that the US Food and Drug Administration informs employees leaving for industry jobs that, despite restrictions on post-employment lobbying, they are still permitted to influence the agency. Peter Doshi reports

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,1 “they do not prohibit the former employee from other activities, including working ‘behind the scenes.’”

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The legal ability to work “behind the scenes” is enshrined in federal regulations2 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.”

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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 (see Related Content). (Fink and Goswami were the subject of a previous BMJ investigation into the revolving door between the FDA and industry.3)

www.bmj.com/content/386/bmj.q1418

h/t S-man

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