Senate Panel Views FDA/PDUFA Bill

The US Senate Labor and Human Resources Committee did not, as expected,mark up the Food and Drug Administration modernization/Prescription Drug User Fee reauthorization legislation on June 11 (Marketletter June 9). It listened to opening statements from Senators, but substantive discussion was put off until the following week.

Senator Edward Kennedy offered no formal amendment during the talks but voiced concerns, particularly relating to mandatory third-party review of medical devices. However, a source told the Marketletter, Sen Kennedy has also said repeatedly that the user fee is extremely important and must be renewed as soon as possible. A spokesman for the Pharmaceutical Research and Manufacturers of America said that, overall, this is a good bill, and that with goodwill about user fees on both sides, it is hopeful for compromise and that the bill will move forward.

Bill "A Priority," Says Committee Chairman The bill has bipartisan support, and is a priority for panel chairman Jim Jeffords. Further details have been released on its contents, which include: - a three-tier system for manufacturing changes to make improvements more efficiently without compromising safety; - allowing pilot plants and small-scale manufacturing to be used to show safety and effectiveness so the FDA can approve a product before scale-up; - changes to data requirements which give the FDA flexibility to accept abbreviated reports of clinical trials where appropriate. This could lessen the material needed for New Drug Application submissions, and might also shorten review and approval times; and - authorizing the Health and Human Services Secretary to set standards for approval of biologics, to minimize the difference between regulation of drugs and biologics.