On August 3, the Senate passed legislation (H.R.2430) by a vote of 94-1 that extends for five years the FDA’s authority to collect user fees from drug- and medical-device makers for reviewing new products, sending it to President Trump for his signature. The House passed the bill in July.
The bill would reauthorize user fees for prescription drugs, medical devices, generic drugs, and biosimilar products from fiscal 2018 through 2022. They are set to expire on Sept. 30.
The FDA submits recommendations to Congress for each reauthorization cycle based on negotiations with industry over the framework for the fees and performance goals for the agency.