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On May 30, the House passed its version of the bipartisan FDA user fee legislation, H.R. 5651, by a vote of 387 to 5, setting up a conference between the House and the Senate to reconcile the differences between the two versions of the legislation. The legislation includes a 5-year reauthorization for FDA programs that help fund the review of medical devices and prescription drugs and also creates user fee programs for generic drugs and generic biologic drugs. The legislation was considered under an expedited procedure known as under suspension of the rules, which requires a two-thirds majority for passage. While this process does not allow amendments, House members did make technical changes to the final bill. The legislation also includes much-needed FDA reforms. The Senate passed its version, S. 3187, by a vote of 96 to 1. The conference committee process is expected to begin in an effort to set up quick votes in both the House and the Senate with the goal of sending the final bill to the President before July 4. While the two bills are similar, some differences do remain in several medical device provisions, as well as in the generic drug pay-fors and drug track and trace language. |
