FDA Staff Provided Lobbying Advice Before Industry Decision

The US Food and Drug Administration (FDA) is telling employees leaving industry jobs that despite restrictions on post-employment lobbying, they are still allowed to influence the agency, a BMJ investigation reveals today.

Internal emails obtained through a Freedom of Information request show how two FDA officials who worked on COVID-19 vaccine approvals were proactively briefed by FDA ethics staff about their ability to indirectly lobby the agency as they left their positions at Moderna.

The facts show that since 2000, all FDA commissioners, the agency’s highest position, have continued to work for industry.

“So people will leave government service and immediately be able to engage in influence peddling and lobbying,” says Craig Holman, a government affairs lobbyist with Public Citizen. “They can even lobby, as long as they don’t pick up the phone to contact their former bosses – and that’s exactly the advice here.”

Diana Zuckerman, president of the nonprofit National Center for Health Research and a decades-long regulatory policy analyst, finds the FDA’s proactive promotion of behind-the-scenes activities particularly troubling. Behind-the-scenes advice is precisely “what makes FDA scientists and staff valuable,” she says.

Peter Lurie, president of the Center for Science in the Public Interest in Washington, D.C., and a former associate commissioner of the FDA, suspects that the FDA’s ethics staff was simply doing its job, but he expressed concern about the dangers of allowing behind-the-scenes work.

“It seems contrary to the public interest for a former official to be able to direct behind-the-scenes activities, particularly for a ‘special case’ that he or she worked on,” he said. “In practice, this policy likely plays out in a way that favors the interests of big pharma, because that’s where many officials go after the FDA.”

The BMJ asked the FDA whether it was concerned that proactively informing employees of their ability to work behind the scenes could be interpreted as indirectly encouraging former FDA employees 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 must comply with these requirements, just like any other person or organization.”

Last month, U.S. lawmakers introduced bills to change the law governing restrictions on employees leaving their jobs. They seek to prohibit former health care employees from serving on the boards of drug, biologics or device makers after their government service. So far, none of the bills have passed.