Departing FDA staffers told they can still influence the agency in Big Pharma jobs: BMJ report

Under federal law, former FDA employees are prohibited from engaging in certain lobbying activities—but an investigation published in the BMJ medical journal on Monday claims that the agency’s staffers are often advised of loopholes in those regulations on their way out the door.

Federal ethics requirements (PDF) governing the behavior of ex-staffers of the Executive Branch—which includes the FDA—place a permanent ban on “switching sides,” meaning that they may never communicate with or appear in front of the government on behalf of their new employer regarding matters in which they “personally and substantially” participated during their public service.

Plus, for two years after they leave the government, ex-employees are banned from engaging in those lobbying activities on behalf of matters that they weren’t personally involved in but that were in the realm of their “official responsibility” during the last year of their service.

Meanwhile, those classified as “senior employees” of federal agencies are subject to an additional “cooling-off period” for one year after they leave the government, during which time they cannot contact or meet with their former agency “with the intent to influence” on anyone’s behalf.

According to the BMJ’s investigation, the FDA’s own ethics team offers information to departing staffers about what’s still allowed under those restrictions. Internal emails that the journal’s investigations unit obtained through a Freedom of Information Act request, for example, reportedly show FDA ethics staffers telling two agency officials who had worked on COVID-19 vaccine approvals and who were moving on to roles at Moderna that they could still work with the FDA indirectly, “behind the scenes,” from their new postings.

“So, people will leave government service and can immediately start doing influence peddling and lobbying,” Craig Holman, a government affairs lobbyist for nonprofit Public Citizen, said in the report. “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.”

When asked by the investigators whether the practice of telling departing employees about indirect avenues to influencing the agency is any cause for concern, an FDA spokesperson said, “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.”

Though the advice offered by the FDA ethics officials is perfectly legal under current regulations, it may be seen as an ethically murky practice, especially since countless agency staffers go on to work at the drugmakers and other companies they previously regulated—including every FDA commissioner since 2000, per the BMJ.

“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,” said Peter Lurie, a former associate commissioner at the agency and now president of the Center for Science in the Public Interest. “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.”

Several bills have been proposed in recent years further limiting or completely banning lobbying for former legislators and other government employees, including two introduced just last month that would limit the ability of former federal health sector workers from joining the boards of drug and device makers, but which have yet to be passed, according to the report.