The U.S. Food and Drug Administration (FDA) encourages staffers departing for pharmaceutical industry jobs that they can work behind the scenes to influence the regulator's decision-making.
The British Medical Journal (BMJ) disclosed this in a July 1 feature penned by its senior editor Peter Doshi. He cited an internal email obtained by the publication through a Freedom of Information request. The said email was sent to departing staffer Dr. Doran Fink, who reviewed Wuhan coronavirus (COVID-19) vaccines while at the FDA and accepted a job at COVID-19 vaccine manufacturer Moderna.
According to the correspondence, U.S. law prohibits some forms of lobbying contact between former FDA staffers who leave to join the private sector. However, the same law doesn't prohibit former employees from "other activities, including working 'behind the scenes.'"
Doshi, also an associate professor of pharmaceutical health services research at the University of Maryland's School of Pharmacy, said the FDA's ethics program staff emailed the information to Fink as he was completing his exit requirements. The guidance seems to be part of the standard boilerplate advice sent to employees, and has been included on an FDA web page detailing post-employment restrictions since June 2017.
Doshi told the Defender he was surprised to see "just how proactive FDA is at informing departing employees of their ability to work behind the scenes post-FDA." He continued: "I was even more surprised to learn that the phrase 'behind-the-scenes assistance' actually appears in U.S. regulations."
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U.S. law prohibits direct lobbying, but allows indirect contact
While U.S. law forbids direct lobbying between former regulatory staff and federal agencies, it allows indirect contact. But Doshi remarked that he is "yet to hear an argument for how this serves the public interest."
He also mentioned in the BMJ report that Fink wasn't the only one who received an email, as former staffer Dr. Jaya Goswami was also sent the message. Goswami served as a medical officer in the FDA's Center for Biologics Evaluation and Research from March 2020 to June 2022.
During her time at the FDA, Goswami was responsible for evaluating whether the clinical data for Moderna’s COVID-19 vaccine met regulatory standards for approval. Just like Fink, she joined Moderna as its director of clinical development in infectious diseases after the FDA stint.
Craig Holman, a government affairs lobbyist for the consumer advocacy nonprofit Public Citizen, said the legal ability to work "behind the scenes" is woven into federal regulations. This, he added, highlights a critical loophole in U.S. revolving door policy. Holman also described this legally sanctioned revolving door between U.S. regulators and the industries they regulate as "the most pernicious influence-peddling scheme available to wealthy special interests."
"So, people will leave government service and can immediately start doing influence peddling and lobbying. 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. That's exactly the advice that's being given here," said Holman.
"The prospects of lucrative private employment after public service can influence official actions by regulators. And the inside connection within the regulatory agency by [the person leaving federal service to work for industry] gives the business community a strong advantage over influencing upcoming regulatory actions."
Diana Zuckerman, president of the nonprofit National Center for Health Research, also expressed surprise by the FDA's advice on behind-the-scenes work. She also voiced concern about how proactive the FDA was in providing behind-the-scenes work information to workers as they leave federal service.
"I had this vision that they actually had meaningful restrictions on what people could do for at least a year [after federal service], said Zuckerman, a regulatory policy analyst with decades of experience.
"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.'"
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