The United States Congress is currently debating a major piece of health care policy called the Prescription Drug and User Fee Act  (PDUFA). While you may not have heard of PDUFA before, it has had a positive effect on patients and California businesses since 1992.  The Campaign for Modern Medicines, a coalition organized by pharmaceutical companies, is working to support reauthorization of the Act by Congress this year. And while PDUFA has broad bipartisan support, there will be attempts to add on unnecessary elements that will reduce the effectiveness of the program.

First, some background: In response to the slow pace of new drug review by the U.S. Food and Drug Administration (FDA), Congress passed PDUFA in 1992 and required that the program be reauthorized by Congress every five years. PDUFA is a user fee arrangement between the FDA and the biopharmaceutical industry that provides additional funding to the FDA so they have the resources necessary to review new drug applications more quickly. In return, companies submitting new drug applications into the FDA are given a fixed timeline for when their drug review will be completed. This user fee arrangement does not guarantee the FDA will approve the application, but instead expedites the new drug review process so new, safe and innovative medicines get to patients faster. Since PDUFA was passed in 1992, more than 1,000 new drugs have been approved, including: 90 new cancer drugs, 125 anti-infective drugs, 138 drugs for neurological and psychiatric disorders, and 106 new drugs to treat cardiovascular and renal disease

In addition to benefitting patients, PDUFA helped the biopharmaceutical industry in the U.S. grow and prosper. With a regulatory system in place that provides certainty that new drug applications will be reviewed in a timely manner, these companies are more willing to spend the time and money in the U.S. market (currently 12 years and over a billion dollars) necessary to develop and bring to market a new medication. Due in large part to the passage and subsequent reauthorizations of PDUFA, more than 50% of new drugs are launched in the U.S. now (as opposed to overseas), compared to only 8% pre-PDUFA. The reauthorization of PDUFA is crucial to the biopharmaceutical companies in California and to those who want to support the industry’s continued growth in-state.

The current user fee agreement, PDUFA IV, expires on September 30, 2012. Congress must reauthorize PDUFA by that date in order to keep the program operational. In past reauthorizations of PDUFA, Congress made legislative changes that reduced its effectiveness and impaired the FDA’s ability to review new drug applications efficiently, ultimately delaying safe, innovative medicines from reaching patients.

CSAC has not yet taken a position on PDUFA.  Congress is debating this bill now in committee and consideration by the full House and Senate will take place in the coming months.   You can learn more about this issue by visiting www.modernmedicines.com.