A revolving door between FDA and the pharma industry raises questions about 'whether regulators indefatigably act in the public interest'

REUTERS/John Kolesidis

A pharmacist arranges drugs in a pharmacy in Athens March 1, 2012.

To get a drug approved in the US, it has to pass through the regulatory hands of the Food and Drug Administration.

The process takes time, and there's a lot of communication between medical reviewers at the agency and the companies that are developing the drug.

But where do those medical reviewers go when they leave the FDA?

Dr. Vinay Prasad, a professor of medicine at the Oregon Health and Science University, told Business Insider that he had been hearing anecdotally that after leaving the FDA, reviewers would take a job within the drug industry - something that could lead to serious conflicts of interest. But there weren't any overarching statistics that he could find about that career trajectory, commonly referred to as a "revolving door."

So Prasad, along with Jeffrey Bien, an internal medicine resident at OHSU, focused specifically on hematology-oncologist drug reviewers, who worked on cancer drugs at the FDA from 2001 to 2010. (That means the results may not be representative across the agency, but the numbers a good starting point for future analysis.)

Of the 55 reviewers, about half (27 reviewers) are still with the agency. But of the 26 that left the FDA, 15 of them went on to work for the biopharmaceutical industry, or about 60%. The researchers couldn't identify the next job of another eight of those who had left the agency, so that number in the biopharmaceutical industry could be even higher. Their findings were published in a letter to the BMJ.

Prasad said he was surprised to see so many people go from the FDA to the drug industry, in part because of the variety of degrees the reviewers had. If they wanted to, he said, many could've gone on other paths, including practicing medicine.

The concern Prasad has with people moving from regulation to the industry they were just regulating isn't really about anything happening outright (like promising someone a job if a drug gets approved) than it is about the reviewers knowing that they've got a 60% chance of being on the other side of the table in a few years.

"You're not going to be a tough negotiator," he said.

While people leaving the FDA and immediately entering industry is concerning, moves in the other direction - from industry directly into the FDA - are worrisome too.

Last year, after lax regulation at the FDA involving a potentially dangerous ingredient found in supplements, The New York Times Editorial Board took a strong stance against the agency's "revolving door." They wrote:

The F.D.A. says it hires people with industry ties because it needs experts from diverse backgrounds in public health, academia, science and industry working collaboratively to produce the best health outcomes. And some experts say that an industry perspective helps the agency understand what impact a regulatory action might have in the business world.

But consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions.

Prasad and Bien brought up similar questions in their letter in the BMJ. "The transition from regulator to advising companies seems logical," they wrote, "but it raises concern as to whether regulators indefatigably act in the public interest."