BIO testifies in support of reauthorization of the Prescription Drug User Fee Act

Testifying before the House Subcommittee on Health on behalf of the Biotechnology Industry Organization, Richard Pops, CEO of Alkermes, called on Congress to reauthorize the Prescription Drug User Fee Act (PDUFA).The PDUFA allows the FDA to collect fees from entities seeking the approval of a new drug or biologic product. It also authorizes fees based on manufacturing facilities and covered products currently on the market. The FDA uses the revenue to fund and expedite the application review process. First enacted in 1992, the PDUFA was reauthorized in 1997, 2002, and 2007. Congress is considering its fifth reauthorization this year.

Pops indicated that since 1992, the user fees prescribed under the PDUFA have reduced the review time for new drugs by more than year. Still, he pointed out that the average time it takes for a treatment to become available to patients from the time of its discovery is 10 to 15 years.

He stated:

In short, BIO supports quick enactment of the PDUFA V recommendations as we believe they can enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance. Most importantly, from the standpoint of young, innovative companies, our hope is that PDUFA V will provide patients and doctors with earlier access to breakthrough therapies.

Pops said that the PDUFA V will make possible the following:

- greater scientific dialogue and transparency between FDA and Sponsors under the proposed review program for novel drugs and biologics;
- enhanced communication during drug development between FDA and Sponsors;
- modernization of regulatory science;
- robust drug safety and post-market surveillance capacity.

In addition, Pops discussed the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) which he said "have generated a wealth of pediatric drug information for physicians and parents, contributing to improved health outcomes for pediatric patients." He called on Congress to "(1) reauthorize the existing framework and incentive for ongoing pediatric research and (2) make the programs permanent by eliminating their sunset provisions."

As reported in Genetic Engineering & Biotechnology News, FDA Commissioner Margaret A. Hamburg has also called on Congress to approve the fifth authorization of the PDUFA.