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From FDA expert to biotech insider: The drug industry thrives on the revolving door
By Sheila Kaplan Sept. 27, 2016
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 Chip Somodevilla/Getty Images
WASHINGTON — Critics of the revolving door between government and industry cite the hundreds of lawmakers-turned-lobbyists as case studies in the art of cashing in on one’s years of public service.
But less is known about the revolving door between the Food and Drug Administration and the biopharmaceutical industry.
In a study published Tuesday in the journal BMJ, researchers who studied the careers of FDA medical reviewers found that more than half of the hematology-oncology assessors who reviewed drugs between 2001 and 2010 went on to work for the biopharmaceutical industry.
“I think it’s astonishingly high,” said Dr. Vinay Prasad, senior author on the paper and assistant professor of medicine at Oregon Health and Science University. “When you are talking about cancer drugs, with high toxicity and sometimes small benefit, it’s a place where judgment really matters. “
Prasad also wonders if reviewers might make more favorable calculations if they are looking ahead to more lucrative industry work in the future.
“If you know a major post-employment opportunity is on the other side of the table, you give them the benefit of the doubt,” Prasad said. “You, maybe, make things a little easier on the companies.”
Prasad launched the study after asking colleagues who study medical ethics whether anyone knew how often reviewers went from the FDA to industry.
“Those of us who follow this field of FDA regulation know anecdotal stories of people who work for FDA and then immediately went to the drug industry,” said Prasad, “but nobody knew how often.”
Prasad enlisted medical resident Dr. Jeffrey Bien, who serves as lead author. Prasad and Bien identified all the reviewers in the FDA hematology-oncology section who worked on applications between 2001 and 2010.
Nearly half were still working at the FDA. But of the 26 who left the agency, 15, or nearly 58 percent, had gone to work in some capacity for biopharmaceutical companies. (Thirty percent of the reviewers who left the FDA could not be identified.)
Genevieve Pham-Kanter, a well-known health economist who studies conflicts of interest in the regulatory field, praised the report.
“There haven’t been many quantitative studies on the revolving door at the FDA, so we didn’t really have a sense of the scope and scale of these transitions to industry before now,” said Pham-Kanter, assistant professor at Drexel University and a senior fellow at Leonard Davis Institute of Health Economics at the University of Pennsylvania.
“This study gives us a good start on knowing the current baseline in a medical specialty that has historically had a lot of industry ties,” she said.
Pham-Kanter also cautioned against assuming that the pattern of FDA staffers leaving the agency to work for industry is troubling.
“If individuals who work in industry are more informed about the regulatory process because of these employment transitions, that’s not a bad thing,” she said. “On the other hand, if former FDA staffers, in their current roles in industry, try to influence their former colleagues at the FDA, we should be concerned.”
FDA spokesman Jason Young noted that the revolving door dynamic is not unique to the agency.
“The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization, or individual,” Young said.
After they leave the agency, Young said, they are subject to additional rules that protect confidentiality of information they worked on while in federal service, a cooling-off period for senior employees, and other post-employment restrictions.
Prasad is not convinced there’s no conflict of interest.
“I’m not paranoid. These are good people,” he said. “But like all people, we’re swayed.” |
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