Much conversation about the FDA’s revised guidance on advisory committee conflict of interest waivers. Commissioner Hamburg wants a “stricter” policy.
Transparency? Certainly. But what exactly is the problem that requires stricter guidance? It’s not COI – its empty seats. 218 positions of the 600-plus on FDA's 49 advisory committees have yet to be filled.
According to the Pink Sheet, The general perception has been that the conflict-of-interest policy has made it more difficult to properly recruit for advisory committees. "There have been places where we felt we didn't have the right experts and we cancelled the meetings," John Jenkins, director of the Office of New Drugs, told attendees at the FDA/CMS Summit in December 2009 "We may have gone too far."
During my tenure at the FDA I was the senior official in charge of advisory committee oversight and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.
And we should all pay attention to the nomenclature. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.” And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.
