pdufa 101

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PDUFA 101 What is PDUFA?

The Prescription Drug User Fee Act (PDUFA) was first authorized in 1992 to bring new medicines to Americans more quickly. Because of limited resources available to the Food and Drug Administration (FDA) in the early 1990s as well as a lack of performance goals for reviewing applications for new medicines, the FDA was unable to manage its mounting drug review workload in a timely manner. A consequence of this backlog was an increasing amount of time that it took new medicines to come to be available to patients and healthcare professionals. PDUFA was first enacted as a bipartisan solution to increase the efficiency of prescription drug reviews at FDA. PDUFA increased FDA resources by authorizing the agency to collect user fees from the biopharmaceutical industry. Under PDUFA, the FDA must also meet certain performance benchmarks which ensure timely reviews of new drug and biologic applications. PDUFA has been reauthorized three times since 1992 and has consistently enjoyed strong bi-partisan support. The program must be reauthorized again before it expires in September 2012.

Why is PDUFA important?

PDUFA has been an immense success for patients. Since 1992, PDUFA has provided faster access to over 1,500 new drugs and biologics, including treatments for cancer, cardiovascular disease, neurological diseases, infectious diseases and others. PDUFA has also helped improve America’s competitiveness around the world. Since its passage, the U.S. has been the world leader in getting new medicines to market first and is the world leader in biotechnology R&D. By providing the FDA with greater resources, PDUFA has provided for greater certainty, predictability and efficiency to the drug review process, which are keys to both continued medical innovation and economic growth. Biopharmaceutical jobs are vital to America’s economic sustainability and reauthorizing PDUFA will help ensure future growth. A report by Battelle found that the U.S. biopharmaceutical sector is “well recognized as a dynamic and innovative business sector generating high quality jobs and powering economic output and exports for the U.S. economy.” According to the report, nationwide the total economic output from the sector’s direct, indirect and induced impacts was $918 billion. In total, the sector supported about 4 million jobs in 2009, including more than 650,000 direct jobs.

Each Direct Job in the Biopharmaceutical Industry Supports 5 Additional Jobs in other Sectors of the U.S. Economy:

supports

More than 650,000 Direct Jobs

About 4 Million Jobs Total

Total economic impact of industry: $918 Billion

How does PDUFA work? Under PDUFA, the biopharmaceutical industry pays user fees when submitting new drug applications, and yearly fees for both establishments (e.g., drug manufacturing facilities) and approved products. The Agency in turn agrees to meet specific performance goals. FDA uses these fees to hire more drug review and support personnel, upgrade its technology, and fund post-market drug safety activities. PDUFA user fees supplement, rather than replace Congressional appropriations, so that the total resources available for drugs reviews are markedly increased.

What is in the PDUFA V agreement? The PDUFA V agreement will help to ensure that the FDA has the tools and resources necessary to keep pace with biopharmaceutical innovation. The agreement maintains the basic structure of the human drug review program, including FDA’s high review standards for safety and efficacy. Further, the agreement will provide the FDA with tools to make new medicines available to patients in a more efficient, consistent and timely manner. In addition, it will also advance the development of drugs for rare diseases, implement a benefit-risk framework that includes patient-focused drug development, ensure quality of patient-reported outcomes, and enhance communications between the FDA and developers during drug development.

What happens if PDUFA is not reauthorized by September 2012? Timely reauthorization of PDUFA will help ensure that an efficient and predictable process exists for the review of new medicines. PDUFA IV expires on September 30, 2012 and must be reauthorized by July 2012 to avoid sending layoff notices to hundreds of drug reviewers and otherwise disrupting the timely availability of new medicines to patients.

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