Sizing up the FDA’s revolving door with industry

When reviewers with the Food and Drug Administration weigh the evidence for a drug company’s experimental treatment, how many are thinking: I may someday work for that company? It’s a difficult question to answer but research by two OHSU physicians provides some of the first hard data.

More than one-fourth of the cancer drug reviewers employed by the U.S. Food and Drug Administration from 2001 through 2010 now work or consult for companies in the biopharmaceutical industry, the authors reported in the British Medical Journal.

“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,”  Drexel University’s Genevieve Pham-Kanter told STAT, the Boston Globe digital health news site.

Jeffrey Bien, M.D., an OHSU internal medicine resident, and Vinay Prasad, M.D., a hematologist-oncologist and assistant professor in the OHSU School of Medicine, used publicly available employment data from LinkedIn and other sources to track 55 hematology-oncology drug reviewers, nearly all of whom were physicians.

They found that about half of the reviewers continued to work exclusively at the FDA. Among the 26 who left the agency, at least 15 jumped to employment in the biopharmaceutical industry.

The ramifications of this flow of FDA personnel are debatable. From the industry’s perspective, physicians and scientists with FDA experience help companies to fulfill regulatory requirements and submit high-quality data. “This knowledge can better inform scientific and medical research and enhance predictability for the benefit of patients,” a spokesman for Pharmaceutical Research and Manufacturers of America told Modern Healthcare.

Bien and Prasad said they’re concerned about a subtle bias that could lead reviewers to ease up on their oversight. “The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest,” they assert in their research letter.

The FDA, in a statement issued to reporters, said that the agency has strong rules in place to ensure that employees work in the public interest and not to advantage any company, organization or individual.

Several high-profile news outlets covered the research, including MedscapeNPR/Kaiser Health NewsTime, and Vox.