FDA drug reviewers often end up at pharma companies

More than a quarter (27 percent) of Food and Drug Administration (FDA) workers responsible for approving cancer and hematology drugs went on to work for the companies making those drugs, according to a new study published in The BMJ.

This “revolving door” between the FDA and the pharmaceutical industry it regulates had been discussed anecdotally, but never quantified, according to study authors Jeffrey Bien, MD, and Vinay Prashad, MD, MPH, of Oregon Health and Science University. They identified 55 hematology-oncology medical reviewers at the FDA between 2001 and 2010, and found 15 who later worked for or consulted in the pharmaceutical industry.

It was more common that reviewers stayed put, with 27 of those 55 still working at the FDA.

“We are concerned by these findings,” Bien and Prashad wrote. “The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest. If anything, we underestimate the extent of this phenomenon, as not all reviewers’ future careers could be identified.”

The study focused on hematology and oncology medications because it spawns so many new drugs, Prashad told Kaiser Health News (KHN), and reviewers are given plenty of autonomy on individual drug approvals. If reviewers are aiming to one day work for the same companies they’re reviewing, Prashad wondered whether it would change their regulatory decisions.

“Sometimes, the public needs [the FDA reviewers] to be firm. If they’re not, no one else in the healthcare sector is going to be,” Prashad said to KHN.

Eventually, this could have an effect on the cost of care, because once the FDA approves the drug, CMS has to cover it and isn’t able to negotiate on prices under current law.

Former FDA Commissioner Margaret Hamburg seemed aware of the appearance of a conflict of interest with these moves in a March interview with STAT News but still didn't support the idea of an absolute firewall.

“This perception of the revolving door is damaging to everyone, and as a principle I am not considering doing any boards of any company big or small that was regulated by the FDA for a couple of years—a cooling-off period—even though some of the smaller biotech companies are technically really interesting, and it would be fascinating to see from the other side,” she said. “It’s unfortunate that people really think there has to be a complete division between the work of FDA and the industry.”

That “cooling-off period” is required for former senior FDA officials, agency spokesman Jason Young, and ex-employees are required to protect confidential information they learned while working in government.