PDUFA: An Enormous Success for Patients

Just a decade ago, the average Food and Drug Administration (FDA) review of a new drug application took about two and one-half years. With the passage of the Prescription Drug User Fee Act (PDUFA), which was first enacted in 1992 and subsequently reauthorized in 1997, that unacceptable situation has changed.

Measurable Results
PDUFA has allowed the FDA to collect user fees from the pharmaceutical industry in order to hire additional drug reviewers. As FDA stated in its Spring 2001 Center for Drug Evaluation and Research (CDER) Update, "PDUFA has been very effective in speeding the movement of prescription drug and biological products to the marketplace."

More Reviewers, Shortened Review Times
PDUFA is a shining example of public policy that has produced positive and tangible results. PDUFA has provided FDA with needed revenue to hire additional reviewers and upgrade information technology, thus enabling the agency to conduct more timely reviews for human drug and biological products without compromising review quality and consumer safety.

• PDUFA has provided FDA with over 1,000 new drug reviewers and reduced drug review times from 30 months to less than 18 months.

• PDUFA has largely eliminated the drug lag that existed between the U.S. and the rest of the world. Today, roughly half of all new drugs are approved first in the United States, and less than 30 percent are marketed in Europe for over a year prior to U.S. approval.

Since PDUFA's inspection in 1992, the FDA has approved 712 drugs, compared to 473 over the previous decade. Currently, America's pharmaceutical companies have over 1,000 new discoveries in the pipeline. This is good news for patients who currently suffer from diseases that have no cure or no treatment.

This information was taken from a document produced by the Pharmaceutical Research and Manufacturers Association.