On June 26, the Senate approved, 92-4, the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187); the House approved the legislation on June 20 (see The Source, 6/22/12). On May 30, the House approved a similar version of the measure, the Food and Drug Administration Reform Act (H.R. 5651) (See The Source, 6/1/12). President Obama is expected to sign the legislation into law.
The bill would reauthorize through FY2017 the FDA’s user fee programs, which fund the agency’s approval process for prescription drugs and medical devices. The legislation includes a provision requiring the FDA to publish a report on its website, and to provide the report to Congress, on the extent to which clinical trial participation and safety and effectiveness data by specific subgroups, including age, gender, race, and ethnicity, is included in the application for FDA approval of drugs and medical devices.
