FDA Pharma Revolving Door

The FDA’s drug reviewers keep leaving to work for big pharma, and it’s a big problem

The Food and Drug Administration has had a “revolving door” problem for years. As consumer advocates have documented, the very government officials who decide how foods and medicines are regulated too often shift over to the same industries they were regulating. Some, like Daniel Fabricant — the former head of FDA’s division of dietary supplements — even return to the FDA, then bounce back to work in industry again.

This trend, the New York Times has pointed out, is like “appointing the fox to guard the henhouse.”

But so far, there have been only anecdotes of these shady practices, and no hard data on how pervasive the problem really is.

That’s what got researchers Vinay Prasad and Jeffrey Bien, of Oregon Health and Science University, to try to come up with an estimate.

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Jobs taken after working in the FDA’s Oncology Products Division. BMJ

In a research letter published today in the BMJ, they found that nearly 60 percent of medical reviewers who left the FDA went on to work for, or consult with, the pharmaceutical industry. This means there may be a lot of foxes out there.

A quick note on the limitations of this data: It’s a small study — involving 55 experts who reviewed applications specifically for new blood cancer drugs between 2001 and 2010. They represent a small subset of the FDA staff who examine the evidence behind drugs for approval — and it’s possible the problem is either more or less pervasive in other areas of cancer research and other areas of food and medicine.

But it’s the best data we have on the problem, and Prasad, a cancer doctor, said he was distressed about the findings. For an FDA worker, “when you know 60 percent of your colleagues who leave go to work for the industry,” he said, “it may make you more likely to be the kind of regulator that gets along well with the industry, helps them shepherd drugs through, and doesn’t push too hard on the warts in a trial.”

Here’s what that might look like. Oncology is the field for which the FDA currently approves the most drugs — yet these drugs typically add only a couple of months to a patient’s survival. What’s more, Prasad said, there is rarely evidence that these drugs improve quality of life, but there’s lots of evidence that they cause severe side effects.

In subtle situations like this, Prasad said, “the discretion of the medical reviewer is really tremendously important.”

And if reviewers happen to be sitting across the table with industry representatives — who are also former colleagues — they may be a little more likely to approve a drug that doesn’t have the greatest evidence behind it, consciously or not. “It makes it hard to be very stringent,” Prasad added.

There are other ways the revolving door can impact what drugs get approved, said Joel Lexchin, a professor at York University in Canada who has long studied conflicts of interest.

“First, these people don’t give up their FDA contacts when they move to industry, and that may give the company they work for preferential access to decision-makers,” he said. “Second, knowing the way the FDA works also means that you know where the weaknesses in the FDA evaluation system are, and it’s possible they may help their company exploit these weaknesses.”

The conflicts — and appearances of conflict — can be insidious. Consider the case of a drug for breast cancer called pertuzumab, which was approved on the basis of a new and never-before-used “surrogate endpoint.” (That’s just a measurable biomarker that doesn’t necessarily translate to clinically meaningful improvements for patients).

Experts questioned the validity of the new endpoint and whether the drug would truly help patients. And it turned out that the FDA official who helped champion that surrogate endpoint and get pertuzumab through the FDA then went to work for Genentech, the company that makes pertuzumab.

This revolving door problem isn’t unique to the FDA; it’s an issue for all government-regulated industries. And there are potential solutions, such as implementing “cooling-off” periods, whereby medical reviewers have to agree to avoiding working at or consulting for the companies they have been regulating for a set amount of time after leaving the FDA. Another is better pay for FDA employees to slow attrition to high-salary industry jobs.

Either way, the new data suggests the revolving door may be large and in need of a stopper.