On May 30, the House approved, 387-5, the Food and Drug Administration (FDA) Reform Act (H.R. 5651). On May 24, the Senate approved its version of the bill – the FDA Safety and Innovation Act (S. 3187) – by a vote of 96-1.
The bills would reauthorize for five years FDA programs that help fund the agency’s review of prescription drugs and medical devices.
The Senate bill incorporates a provision of the Heart Disease Education, Analysis, Research, and Treatment for Women Act (S. 438/H.R. 3526), which would require the FDA to report on the extent to which clinical trial participation, safety, and effectiveness data reported by demographic subgroups, including sex, age, race, and ethnicity, is included in drug and medical device applications made to the FDA. The agency would be required to publish the data on its website and would have to report its findings to Congress.
The bills next will be considered by a House-Senate conference committee to resolve the differences between the two versions.
