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November 10, 2005

Media Inquiries:
Kristen Neese, 301-827-6242
Consumer Inquiries:

FDA Seeks Public Input on Renewal Process for Prescription Drug User Fee Act (PDUFA)

The Food and Drug Administration (FDA) will begin the public process toward reauthorization of the Prescription Drug User Fee Act (PDUFA), the law that allows the agency to help fund programs that have helped product developers get early and frequent advice about how to develop some of the last decades' most innovative and important medicines.

"Prescription drug user fees allow the agency to increase productivity in the review of new medicines and to streamline the regulatory process, so we can continue to provide life-saving medicines to patients faster than was once possible," said Andrew von Eschenbach, MD, FDA Acting Commissioner.

Under PDUFA, FDA has approved more than 1,000 new treatments including: 62 new cancer drugs, 109 new drugs for metabolic and endocrine disorders, 96 new anti-infective drugs, 103 new drugs to treat neurological and psychiatric disorders and 73 new drugs to treat cardiovascular and renal disease. In addition, the median approval time for priority review of new product applications decreased by more than half -- from 13.2 months in 1993 to an estimated six months in FY 2004. Over this same time period, the median approval time for standard applications decreased by more than 50 percent, from 22.1 months in 1993 to 10.5 months in FY 2004.

More and more companies are seeking early advice from FDA. Recent research has shown that this increased communication with the FDA results in a more informed and efficient drug development process for industry sponsors. Since 1999, requests for meetings to discuss products stalled in development have increased more than 200 percent. Requests for consultations to review clinical milestones and next steps in the development process are up more than 60 percent. In the past two years, the number of industry-requested meetings scheduled between FDA and industry sponsors has almost doubled, from 1642 meetings in 2002 to 2132 meetings in 2004.

"These meetings have become one of the most valuable, but often labor-intensive aspects of the development process," said von Eschenbach. "Earlier consultation and feedback from FDA on the sponsor's development program is critical to ensuring safe and effective study designs and increasing the probability that the resulting marketing application will meet regulatory requirements."

As a result of FDA guidance and consultation, the quality of new product applications has improved, and fewer review cycles are needed. Before PDUFA, an average of two review cycles was needed to gain FDA approval for a standard new drug application (NDA). In 2004, thus far the majority of NDAs have been approved after just over one review cycle.

Adding to the increased demand for FDA consultation is the growing industry use of special protocol assessments (SPAs), an expedited evaluation by FDA of certain manufacturing, toxicology and clinical trial protocols to assess whether they are adequate to meet scientific and regulatory requirements. Special protocol assessments provide valuable information for sponsors, significantly reducing regulatory uncertainty and business risks in drug development. Since the start of this program in 1999, the number of special protocol assessments has increased from 71 to 346 in Fiscal Year (FY) 2004.

As part of the process for amending PDUFA legislation, FDA will hold a public meeting on November 14, 2005, to discuss reauthorization of the law and to solicit stakeholder comments about future PDUFA provisions. The meeting will solicit feedback on how PDUFA has helped FDA meet its public health goals and opinions about current aspects of PDUFA that should be changed or retained in order to help the agency better achieve its mission. The meeting format will include presentations by FDA and a series of panels representing different stakeholder interest groups, including patient advocates, consumer organizations, industry, health professionals and academic researchers. The meeting will be held from 9:00 am to 5:00 pm at the Natcher Conference Center, National Institutes of Health (NIH), Bldg. 45, Center Drive, 9000 Rockville Pike, Bethesda, Maryland.

For more details, please see the following FDA website: http://www.fda.gov/oc/meetings/pdufa111405.html.


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