PDUFA V Discussions To Begin With April 12 Meeting

FDA asks participants to focus on user fee processes and funding, not policy.

FDA will launch the next round of user fee deliberations with an April 12 public meeting to solicit input on what features the agency should propose for Prescription Drug User Fee Act V.

In particular, the agency wants to hear an assessment of the performance of the PDUFA IV program, which was authorized by the FDA Amendments Act and expires Sept. 12, 2012, and what parts of it should be retained, changed or discontinued. The need to focus on new authorities granted by FDAAA and to rapidly hire staff has delayed work on some of the PDUFA IV initiatives, FDA concedes.

The agency stresses that comments should focus on process enhancements and funding issues, not policy. FDA's reluctance to discuss policy seems understandable: PDUFA is a fairly simple bill designed to give FDA resources, but two of the last three renewal cycles have involved rewrites to the Food, Drug & Cosmetics Act that have significantly increased the agency's powers and responsibilities. A discussion of larger structural issues also is anticipated this round since, thanks to a provision in FDAAA, consumer groups will now be formally at the negotiation table for the first time.

One of those groups, Consumers Union, developed a preliminary "wish list" of changes it would like to see as part of the user fee renewal, including a requirement that drugs be tested against the medicine considered to be the "best practice" for treating the condition, not placebo (Also see "PDUFA V "Wish List" From Consumers Union Includes Comparative Effectiveness Standard" - Pink Sheet, 9 Sep, 2009.).

Rep. Maurice Hinchey, D-N.Y., also has weighed in on how he would like the user fee program structured. He introduced a bill March 11 that would place all drug user fees in the U.S. Treasury, terminate FDA's authority to negotiate how the fees are used, and establish a mandatory funding level for the agency (Also see "FDA's Appropriations Outlook: More Purse, Emphasis On The Strings" - Pink Sheet, 11 Mar, 2010.).

Consumers Union is backing Hinchey's proposal, citing the tremendous pressure the existing funding system puts on FDA staff to meet deadlines. "By retaining the user fee revenues but eliminating the performance requirements, a larger FDA staff will be able to do its job as a protector of the public safety," CU Health Policy Analyst William Vaughan argues in a March 10 letter of support to Hinchey.

Other topics that could come up at the meeting include researchers' desire for more information on Phase I studies, better oversight of clinical trials and funds for FDA review of direct-to-consumer advertising.

The meeting will consist of presentations by FDA and panels of representatives from different stakeholder groups, such as industry, health professionals, patient advocates and academics, plus opportunities for individuals to comment.

-Cathy Dombrowski ([email protected] )