As May came to a close, the Senate and House both passed legislation that would reauthorize a law that established user fees to help pay for Food and Drug Administration (FDA) reviews of prescription drugs and medical devices. The bills are five-year reauthorizations that allow the FDA to collect user fees from drug and medical device companies and, at the same time, create user fee programs for generic drugs and generic biologic drugs. Provisions in the legislation are also aimed at improving the safety of drug supply chains and encouraging manufacturers to develop and conduct studies on pediatric drugs.
While the two bills are similar, there are some lingering differences that will have to be reconciled. The AVMA’s Governmental Relations Division has been tracking the progress of the legislation and is scrutinizing a provision in the Senate’s legislation that could possibly impact veterinary practitioners who dispense human prescription products. Sections of the bill would give FDA authority to establish a national system to secure the pharmaceutical distribution supply chain.
The Senate passed S. 3187 on May 24 and the House passed H.R. 5651 on May 30. Congressional leaders have set a goal of finalizing a bill by July 4, and the conference committee process in both chambers is underway.
For more information please contact Dr. Ashley Morgan, assistant director, AVMA Governmental Relations Division.