House Passes User Fee Act

Yesterday, by a vote of 387-5, the House approved its version of the Food and Drug Administration (FDA) User Fee Act (H.R. 5651). Representatives Amash (R-MI-3), Hinchey (D-NY-22), Labrador (R-ID-1), McClintock (R-CA-4), and Paul (R-TX-14) voted against the legislation.

The legislation will reauthorize the Prescription Drug User Fee Act and Medical Device User Fee Act, as well as authorize the Generic Drug and Biosimilar User Fee Acts. In addition, the legislation reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Equity Act; contains certain FDA administrative reforms; provides for changes in the regulation of medical devices and prescription drugs; and, provides for additional reporting and other provisions which attempt to address the problem of prescription drug...

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