Letter on Reauthorizing the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA)

May 7, 2007

TO THE MEMBERS OF THE UNITED STATES SENATE:

The U.S. Chamber of Commerce, the world's largest business federation representing more than three million businesses and organizations of every size, sector, and region, generally supports S.1082, the "Food and Drug Administration Revitalization Act," that reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA).

Reauthorizing PDUFA and MDUFMA ensures a clean and timely review process for new medical discoveries of both emerging and well-established innovators. Efficient regulatory review is an essential component to ensuring that new, innovative drug therapies are brought safely to consumers and employers at the lowest possible cost.

While supportive of PDUFA and MDUFMA, the Chamber would like to express serious concerns with several provisions of the bill. The Chamber opposes a potential two-year ban on consumer advertisements. Direct-to-consumer (DTC) advertising provides consumers and employers with valuable basic information on diseases and potentially dangerous health conditions along with the medicines available to treat these conditions. DTC advertising is already strictly regulated by the FDA to ensure accuracy. Restricting businesses' freedom of speech through a proposed moratorium runs afoul of constitutional protections, is anti-free market, and represents unwarranted government interference.

The Chamber is also concerned that the bill would impose burdensome and costly postapproval clinical trials in circumstances where they are unnecessary. Instead, the bill should authorize trials when it is demonstrated that conducting only post-approval studies (e.g. such as information obtained from safety signals, observational studies and peer-reviewed medical journals) inadequately protects consumer safety. In so doing, the bill could reduce the total costs of bringing new and safe medicines to market, while lowering drug prices for the consumer.

Furthermore, the Chamber is concerned that the absence of secured funding for FDAdirected critical path activities and partnerships outside of the Reagan-Udall Foundation risks jeopardizing the program.

The Chamber also opposes the amendment by Senator Dorgan, which would allow for unsafe importation of drugs from other countries of origin, and has serious concerns about the "forced sale" provision included in the amendment.

The Chamber looks forward to working with you on PDUFA and MDUFMA reauthorization and enhancing the effectiveness of this important legislation to promote access to safe and cost-effective medicines for consumers and employers.

Sincerely,
R. Bruce Josten