PDUFA -- All the rest is commentary

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  • 12/02/2011

Always listen to the experts. They’ll tell you what can’t be done and why. Then they do it.  – Robert Heinlein

On Tuesday the Center for Medicine in the Public Interest (www.cmpi.org ) hosted a Capitol Hill panel entitled, “PDUFA without the Politics.” 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.

The participants were pithy, poetic, and pragmatic.

We will shortly post videos of all the aforementioned presenters.  In the meantime, here’s a short news story from Drug Information Daily:

Lawmakers Plan to Use PDUFA V Bill to Ease Conflict Rules for Advisory


Lawmakers plan to attach a bill easing financial conflict rules for FDA advisory panel members to legislation reauthorizing the Prescription Drug User Fee Act (PDUFA), a congressional leader says.

Rep. Michael Burgess (R-Texas) introduced H.R. 3206 last month and said Tuesday it would be attached to the measure authorizing PDUFA V, yet to be introduced to Congress. H.R. 3206 would eliminate the existing financial conflict rules for panelists, opening the door for committee members with greater expertise on the products they discuss.

Burgess, vice chair of the House Energy and Commerce Health Subcommittee, offered similar legislation during consideration of PDUFA IV in 2007, but it was voted down along party lines. With his Republican party now in control of the House, he may have an easier time gaining approval of the bill.

Speaking at a PDUFA V briefing for Capitol Hill staffers hosted by the Center for Medicine in the Public Interest (CMPI), Burgess said there are about 10 strong candidates for legislation to tack on to PDUFA V. One possibility is a bill addressing the issue of drug shortages, he said.

Another likely candidate is a bill to increase incentives for antibiotic makers, according to Foley Hoag lobbyist Paul Kim.

Proactive Lawmakers

Also at the briefing, Peter Pitts, former FDA associate commissioner and president of CMPI, urged Congress to be more proactive in changing the technical letter the FDA and drugmakers agreed to during PDUFA negotiations earlier this year. Specifically, Pitts called for more programs and agency action to address transparency and striking a better risk-benefit balance in product reviews.

Following these recommendations might mean altering the package the FDA and industry ratified, which has only happened once in the previous four PDUFA bills.

Recently, David Wheadon, PhRMA's senior vice president for scientific and regulatory affairs, said the package includes a "robust set of programs" to provide an objective measure of risk-benefit analysis at the agency.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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