Friends of Cancer Research presents a special cancer policy alert on an issue of importance to the cancer and medical research communities.

FDA Publishes Recommendations for PDUFA

Introduction of FDA-Industry Recommendations Marks Official Start of PDUFA IV Debate

On Thursday, January 11, the Food and Drug Administration (FDA) published its recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2008 through 2012. These recommendations are the starting point for the discussion on PDUFA Reauthorization.

The significance of PDUFA to patient access to new treatments cannot be understated. When enacted, this bill will set the funding parameters for the next five years of FDA’s human drug review program. One of the main questions is how far this iteration of PDUFA or accompanying legislation will go in endorsing postmarket drug safety activities. If new FDA- related legislation on drug safety is too rigorous, it could create an environment that does not foster the innovation of new drugs; if new FDA-related legislation is too permissive, it would be faulted for allowing unsafe and unproven drugs on the market. Ultimately, what most patient advocates—and cancer organizations in particular—would like to ensure is that PDUFA is a vehicle for speeding patient access to safe and effective drugs.

Congress did not have input into FDA’s proposed recommendations—they were developed through consultations with industry, scientific and academic experts, healthcare professionals, and patient and consumer groups. The House and Senate are expected to begin holding hearings very shortly on PDUFA as well as other pieces of legislation that come under the PDUFA rubric, such as drug safety.

Background on PDUFA

PDUFA was first authorized in 1992 and has been reauthorized every five years since, most recently in 2002 (PDUFA III). It has increased the resources for FDA’s human drug review process by collecting user fees from industry to complement appropriated federal dollars. Through the combination of user fees and appropriated dollars, FDA has been able to reduce drug review times, thereby allowing patients’ access to new drugs in a more timely manner; hire additional staff to review drug applications; and, increase its information technology investment to improve the review process without compromising the agency’s high standards of approval.

About PDUFA IV

FDA’s proposed PDUFA IV recommendations would significantly expand and advance the agency's drug safety program, boost resources for review of television drug advertising, and ease more efficient development of safe and effective new medications for the American public. To achieve these benefits for the public’s health, FDA proposes, as part of PDUFA reauthorization, that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current program base line.

For drug safety, the FDA recommendations propose substantial new funding ($29 million per year) to enhance and modernize the agency’s drug safety system. These enhancements will help improve the current adverse event reporting system and explore the use of cutting-edge techniques and untapped data sources, such as large medical databases, to identify risks more rapidly and precisely. The agency also proposes to develop and publish a five-year plan that describes how FDA will use these new data sources to improve drug safety.

Drug Safety Related Policy Activities

Friends plans to be very active in the entire PDUFA debate, especially in the area of drug safety. Our organization spearheaded the development of a scientific advisory board to make recommendations for improving drug safety, ensuring new drug access, and strengthening FDA. The committee Friends formed includes academic scientists and clinicians, research advocates, and representatives of the patient community, and is completing work on a white paper that includes the recommendations on how product evaluation should be strengthened.

Up Ahead

FDA is holding a public meeting on February 16, 2007, to solicit public comments and proposed changes to its recommendations before they are officially submitted to Congress. The official Federal Register Notice on these PDUFA recommendations is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07n- 0005-nm00001.pdf..

If you have questions, or need more information, please contact FOCR Director of Government Affairs Jeff Coughlin at (703) 302-1543 or jcoughlin@focr.org.

 

### 

Over the past ten years, Friends of Cancer Research (Friends), a 501 (c)(3) non-profit, has pioneered innovative public-private partnerships, organized critical policy forums, educated the public, and brought together key communities to develop collaborative strategies in the field of cancer research.  Through these efforts, Friends continues its mission in raising awareness on the importance of cancer research to accelerate the progress toward better tools for the prevention, detection, and treatment of all cancers.