Pay-to-play at FDA: A setback for true collaborative efforts

I was disappointed to read about meetings between pharmaceutical companies and the FDA regarding clinical trials for pain. It seems these panels were brokered by entrepreneurial academics more intent on making a buck for themselves rather than advancing the cause of patient care. We’ll see what comes out about it in the future, but the initial reports and email trail revealed by the Washington Post (Pharmaceutical firms paid to attend meetings of panel that advises FDA) don’t look good.

Don’t get me wrong. I think the FDA should seek external input on clinical trial design and that pharmaceutical companies that are putting drugs into the clinic are an essential part of that input. But the most productive and ethical approach is to bring together all the relevant stakeholders including patients, payers, academic researchers, private foundations and other branches of the government like the CDC and CMS. Everyone should contribute to the cost of running the meetings to increase neutrality. It’s also ok to limit the size of the discussions to make them more focused and productive, but the results should be published and initial invitation-only meetings should be followed by public sessions whenever possible.

True collaborative models have been pursued in other therapeutic areas, especially infectious disease and cancer.  Those collaborations are promising and deserve more support. Too bad stories like the one about the pain panels are likely to dominate the narrative and make the path to public/private collaboration even rougher than it already is.

October 7, 2013

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