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Key staffers departing the U.S. Food and Drug Administration (FDA) for influential posts in Big Pharma companies are encouraged by the FDA to continue lobbying the agency “behind the scenes” — and one expert says that this practice is legal thanks to loopholes in federal lobbying laws.
Craig Holman, Ph.D., a government affairs lobbyist for the consumer advocacy group Public Citizen, joined “The Defender In-Depth” to discuss the “revolving door” between federal agencies and the private industries those agencies are supposed to regulate.
Much of the discussion focused on the findings of a recent investigation by The BMJ, which revealed that the FDA explicitly instructs departing staffers on how they can continue to lobby the agency “behind the scenes.”
Holman said such practices, prevalent across federal health agencies, adversely affect agency decision-making and undermine public trust. Efforts to rein them in legislatively have thus far been stymied, he said.
‘Revolving door … one of the most pernicious influence-peddling tools’
Holman, who was interviewed by The BMJ as part of its investigation, said the “revolving door” is “one of the most pernicious influence-peddling tools available.”
He said the revolving door “spins two ways” — industry can hire former government officials “at a very lucrative salary” to serve as lobbyists, while Big Pharma executives also aim to go “into the agency itself.”
“The health industry, Moderna, Pfizer, are just dying to get a hold of a former FDA official, especially senior officials and reviewers, to hire them as their lobbyists because they have all the inside connections to the FDA,” Holman said.
“Unlike regular lobbyists who may not have any connection with the FDA, these ‘revolvers’ are exceedingly effective at influencing their former agency,” he added.
According to Holman, Big Pharma firms also “really want their senior executives to actually get employed within the FDA because then they’ve got a foothold right inside the agency itself and they get their own former employees writing, drafting, promoting legislation contracts that directly benefit their former employer.”
“That’s called the ‘reverse revolving door,’ and it results in what we call regulatory capture,” Holman said.
Such practices circumvent the Lobbying Disclosure Act, which Holman characterized as “loophole-ridden.”
“The problem is it only restricts lobbying contacts,” Holman said, noting that the law does not prohibit “indirect lobbying.”
“So those former officials can actually join a lobbying firm or run the lobbying shop for Moderna or whatever other pharmaceutical company immediately after leaving government service,” Holman said.
“The only thing they are prohibited from doing for one year is picking up the telephone and making the phone call themselves to their colleagues back at the FDA.”
Existing legislation does not bar pharmaceutical companies or other private employers from actively recruiting federal employees, Holman said.
“There are very few restrictions on the recruitment. I mean, private companies will seek out, especially examiners and other senior officials within the FDA or other government agencies and offer them very lucrative employment,” Holman said.
‘Revolving door’ particularly ‘out of control when it comes to the FDA’
In the case of the FDA, Holman said The BMJ’s investigation revealed that the agency actively encourages such practices.
“What they’re doing is they’re pointing out to former officials exactly how they can get around the revolving door law and continue to serve as influence peddlers at a very lucrative salary at Moderna, Pfizer or wherever they’ve gone to,” Holman said. “It’s basically the Wild West.”
In one instance, an internal email obtained by The BMJ showed that the FDA told departing staffer Doran Fink, M.D., Ph.D. — who had reviewed COVID-19 vaccines while working at the FDA and who had later accepted a job at Moderna — that although U.S. law prohibits some forms of lobbying contact between former FDA workers who leave to join the private sector, they “do not prohibit the former employee from other activities, including working ‘behind the scenes.’”
In another instance previously revealed by The BMJ, Dr. Jaya Goswami, in March 2020, became a medical officer in the FDA’s Center for Biologics Evaluation and Research where she was responsible for evaluating whether the clinical data for Moderna’s COVID-19 vaccine met regulatory standards for approval.
In June 2022, Goswami left the FDA and joined Moderna as its director of clinical development in infectious diseases, her LinkedIn profile (which is no longer visible) stated, according to The BMJ.
Holman told The Defender In-Depth that the “revolving door” is particularly “out of control when it comes to the FDA … and the healthcare industry.”
“The revolving door … is most prevalent among those industries that are very high finance,” Holman said. “Healthcare is like the number one industry when it comes to lobbying and campaign contributions,” noting that it “is such a wealthy industry that they can afford that ‘revolving door’ abuse and getting the inside connections.”
Holman cited figures from The BMJ’s investigation showing that “the healthcare industry spent just last year about $383 million on lobbying and another $112 million on making campaign contributions to public officials. And of the lobbying activity, literally 60% of its lobbyists are ‘revolvers.’ They’re former government officials.”
Further highlighting the prevalence of the “revolving door” between federal regulatory agencies and Big Pharma, Holman said, “Between 2004 and 2020 of people going into the healthcare government agencies ranging from the FDA to the CDC, 15% came from private companies like Moderna or Pfizer.”
“When they left, 32% joined those private companies in the FDA, specifically people coming into the FDA. About 12% came from these private companies and when they left, 40% became revolvers working for those private companies,” Holman added.
“And literally all FDA commissioners have become revolvers once they leave government service, they get … lucrative employment with the private sector. And so, the revolving door is really out of control at the FDA,” Holman said.
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‘Whose interest is the FDA working on behalf of?’
According to Holman, the “revolving door” harms the public, as it negatively influences the decision-making of regulatory bodies such as the FDA. He said:
“Imagine stepping into a government role as an examiner at the FDA, and you get paid fairly well as a government official and examiner, but you realize that after your government service, if you please Moderna or Pfizer or some other private company that you’re overseeing … they will employ you after your government service [with] an exceedingly lucrative salary.
“And when you’ve got that realization in the back of your mind, undoubtedly that frequently influences the official actions taken by these government officials. They know that … if they quickly approve the Moderna vaccine, they’ve got a very lucrative job waiting for them at Moderna right afterward.”
Such practices “heavily undermine the credibility of government agencies, especially like the FDA, [which are] supposed to be science-based,” Holman said:
“We really count on agencies like the FDA to do the best they can coming up with scientific analysis and helping us get through it.
“But when we see the abuse of the revolving door and the regulatory capture by private industries of the FDA, you’ve got to wonder whose interest is the FDA working on behalf of? Are they working on behalf of our interest or on behalf of the healthcare industry and private companies?”
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FDA ‘does not have a good track record when it comes to ethics’
Holman said federal law does not stop agencies such as the FDA from implementing their own, stricter lobbying and ethics rules. However, most federal agencies — including the FDA — haven’t done so, instead opting to “just rely on whatever Congress has developed in federal law.”
“The FDA and any agency can come out with additional ethics restrictions that go beyond federal law. They can shut down the revolving door if they really want to. They could impose that type of ethics pledge of incoming employees requiring them to not take official actions that affect their former employers or clients,” Holman said.
“But this is an agency that does not have a good track record when it comes to ethics,” he added.
Holman said legislative efforts to pass bills that would rein in the “revolving door” have been stymied, including his own efforts in 2008 to pass the Honest Leadership and Open Government Act, on which he worked with then-Senator Barack Obama.
“We had drafted a very strong revolving door policy that imposed a two-year cooling off on former officials and included a ban on lobbying activity as well as a ban on lobbying contact,” he said. But several members of Congress “revolted” and threatened to “kill the entire ethics, honest leadership and open government law.”
Similar legislation Holman helped draft in 2021 “didn’t go anywhere,” but some of its provisions have been incorporated into proposed bills now pending in Congress. Holman noted that while such bills have a low chance of passing during the current congressional session, their introduction raises public awareness of these issues.
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