FDA User Fees Bill Voted Out of Senate Committee

The Senate Health, Education, Labor & Pensions Committee 5/11 voted 21-2 to advance S. 934, the FDA Reauthorization Act of 2017, that would reauthorize FDA’s user fee programs for another five years beginning 10/1. The measure includes new sections on pediatric drugs/devices, improvements related to drugs, and device inspection and regulatory improvements, among other provisions (see earlier story).

In moving the bill out of committee and onto the Senate floor for debate, lawmakers adopted two amendments on investigational drug expanded access and expediting review and approval of generic drug applications when there is no or limited competition in the marketplace. Another amendment offered by Sen. Bernie Sanders (D-VT) to allow Americans to import certain drugs from Canada was tabled by the committee and may be discussed during floor debate.