According to Plato, “They certainly give very strange names to diseases.” Well, he clearly never encountered PDUFA -- otherwise the might have hit the hemlock too.
Ask me and I'll tell you that PDUFA ought to stand for the "Predictability Deposit User Fee Act." According to Tim Franson, one of the "Fathers of PDUFA," it means “Pharma’s Dollars Underwriting Federal Appropriations.” And when Paul Kim was on the Hill, he wanted to call it the “Giant Omnibus Drug and Medical Device Amendments Act” or GODDMAA.
Alas – cooler heads prevailed.
But PDUFA is more than just a name -- it's a philosophy. And as that well-known expert in FDA policy, William Shakespeare said, “There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.”
Well, neither the Bard nor Horatio could make it to “PDUFA Without the Politics,” CMPI’s Capitol Hill seminar on the fifth iteration of the original UFA, but many hornblowers and FDA cognoscenti did. I was the moderator and was honored to be joined by a panel of peerless nonpareils that included Vincent J. Ventimiglia, Jr (Former Assistant Secretary for Legislation at the US Department of Health and Human Services), Paul T. Kim (Former Deputy Staff Director for health policy for Senator Edward M. Kennedy), Michele J. Orza (Former Assistant Director of the Health Care Team at the Government Accountability Office), and Tim Franson (Former Vice President, Global Regulatory Affairs, Eli Lilly & Co., President, USP Convention).
The Honorable Michael C. Burgess, M.D. (Vice-Chairman, Subcommittee on Health, U.S. House of Representatives) offered remarks as well – specifically on the issue of FDA advisory committee members and conflicts of interest.
But – see for yourself. Full videos of all the presentations can be found here.
Why PDUFA without the politics? Well – watch the presentations and I challenge you to identify any of the speakers’ politics from their astute commentary on the future of the FDA.
Which is as it should be.