On June 20, the House approved, by voice vote, the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187). The Senate approved the measure on May 24; the House approved its version of the bill, the Food and Drug Administration Reform Act (H.R. 5651), on May 30 (see The Source, 6/1/12).
The measure would reauthorize through FY2017 user fee programs for prescription drugs and medical devices. The bill also would permanently authorize the Best Pharmaceuticals for Children program, which fosters the development of safe prescription drugs for children.
The legislation would incorporate a provision of the Heart Disease Education, Analysis, Research, and Treatment for Women Act (H.R. 3526/S. 438). The provision would require the FDA to report to Congress on, and publish on its website, the extent to which clinical trial data on demographic subgroups, such as sex, age, race, and ethnicity, is included in drug and medical device applications made to the FDA.