More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.
Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, sought to understand the so-called “revolving door” between the FDA and the pharmaceutical industry, which he said is often discussed but hadn’t been quantified.
“We all know about these anecdotal cases” of a person who was “often a major player at the FDA, someone in an important role — and then they leave the FDA and go and work for industry,” Prasad said, but he couldn’t find anyone who knew whether this happened “5 percent or 60 percent” of the time.
Prasad and his colleague Dr. Jeffrey Bien, an internal medicine resident also at Oregon Health, tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010, using LinkedIn, PubMed and other publicly available job data. They found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the biopharmaceutical industry. Put another way, about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated. They published their findings in The BMJ as a research letter.
Going to work for industry after leaving the FDA is not inherently bad, but it does raise some questions.
“If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate,” Prasad said. “Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?”
Prasad focused his research on his own field — hematology-oncology — because it spawns a large number of new drugs and reviewers have a lot of autonomy, he said.
He and Bien tracked reviewers instead of higher ranking officials because reviewers provided a larger sample size, Prasad says. They would have liked to include reviewers named on denials as well, but the denial documents are secret, making it impossible to identify the reviewers.
Although Prasad said FDA reviewers have a lot of power over approvals, Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner until 2011, disagreed.
“There are just so many checks and balances within the review process that it’s really not up to one person by and large,” said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught.”
