On September 17, FDA will hold a public meeting to begin gathering stakeholder input on the implementation of a generic drug user fee program. Earlier this year, President Obama's Fiscal Year (FY) 2011 budget for FDA included $38 million generated from a proposed generic drug user fee program. This reflects an increase over the President's FY2010 budget, which included $36 million from proposed human generic drug fees. With a backlog of applications to review at FDA's Office of Generic Drugs, the industry's Generic Pharmaceutical Association (GPhA) has been open to discussions about a generic user fee program over the last many years. The main industry concerns are that discussions of this fee program not occur within a vacuum and that the proposed program includes performance metrics to ensure measurable program results. While the President's budgets have sent a message to the industry, the actual implementation of the program hinges on Congress, since FDA currently lacks the authority to implement such a program. Whether Congress will pass legislation specific only to this program or a generic user fee program proposal ultimately will be a part of the upcoming reauthorization of the prescription drug and medical device user fee programs in 2012 remains to be seen.

FDA has once previously implemented a generic drug user fee program in the area of animal drugs. The Animal Generic Drug User Fee Act of 2008 was signed by President Bush and was designed to improve the timeliness and predictability of the animal generic drug review process and, over time, shorten the time for FDA review of applications. The goals of shorter reviews and increased predictability for sponsors reflect the same aspirations of the prescription drug and medical device user fee programs. For reference, FDA recently announced that the FY2011 user fee rate for new abbreviated generic animal drug applications will be $92,600. In contrast, the FY2011 user fee rate for human prescription drug applications is $1,542,000 (with clinical data) or $771,000 (without clinical data or if a supplement with clinical data).

In its meeting announcement, FDA identified six areas where it is seeking input:

  • How a generic drug user fee program should differ from existing user fee programs for animal drugs, prescription drugs and medical devices;
  • How a generic drug user fee program should be structured;
  • What performance goals, if any, are recommended for FDA for such a program;
  • Whether there should be a flat fee for applications or a fee structure taking into account more complex products;
  • How implementation of generic drug user fees should impact applications under review in FDA's backlog; and
  • Whether these user fees should support post-marketing safety.

Participants wishing to attend or give an oral presentation at this meeting must register by September 9 at GDUFA_Meeting@fda.hhs.gov. In addition, FDA has established a docket to receive comments through October 17. With user fee program reauthorization approaching in Congress, there will be a legislative vehicle for authorizing a generic drug user fee program and FDA's public meeting signals that the framework for executing such a program is beginning to take more certain shape. Regardless of the vehicle, stakeholder input will be critical to agency input on legislative proposals for this program.