FDA Hematology-Oncology Reviewers Move on to Consult or Work for Biopharmaceutical Companies

Medical reviewers at the US Food and Drug Administration are an important part of regulating therapeutics and ensuring that patients have access to the right medications, but a recent letter published in BMJ has raised concerns about regulators’ tendency to later transition into industry positions.
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Jeffrey Bien, MD, Oregon Health & Science University (Portland, OR), and Vinay Prasad, MD, MPH, Oregon Health & Science University, identified 55 hematology-oncology medical reviewers from 2001 to 2010 and searched them using publically available resources from the Department of Health and Health Services, LinkedIn, and PubMed to determine what fields they entered into after leaving the FDA. Of these, 50 (90%) had an MD, 4 (7.7%) also had a PhD, and 2 (3.8%) also had an MPH. Two reviewers (3.8%) had a PhD alone. They also found 1 each of CRNO, CRNP, and MBBS.

Overall, almost half of the reviewers (49%) continued to work exclusively at the FDA, but 2 (3.6%) worked at the FDA and also held a secondary appointment. Of the 26 (51%) who left the FDA, 15 (57.7%) later worked for the biopharmaceutical industry or consulted for it (10 worked for the industry, 7 consulted for it, and 2 did both). Eight reviewers (30.8%) could not have their subsequent employers identified, but were not concurrent DHHS employees.

“We are concerned by the sizable percentage of medical reviewers at the FDA later work for or consult for the pharmaceutical industry,” authors of the letter wrote. “The transition from regulator to advising companies who are the subject of regulation may seem logical, but it raises concern of whether regulators consistently and indefatigably act in the public’s interest, if the prospect of subsequent employment in the industry is available and prevalent.”

The study was limited by the authors’ focus on hematology and oncology, but Drs Bien and Prasad added that they mostly likely underestimated the extent of this phenomenon, since they were not able to identify the careers of every reviewer. They encourage others to investigate the careers of reviewers in different therapeutic fields and recommend that the FDA analyze the question using their own comprehensive roster of employees.