Sunday, October 02, 2016

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

Updated by Julia Belluz  @juliaoftoronto  julia.belluz@voxmedia.com Sep 28, 2016, 6:00a

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.

 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."

Read more
http://www.vox.com/2016/9/28/13059538/fda-drug-regulation-revolving-door

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