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House passes bill to access generic user fees

September 21, 2012 12:29 AM UTC

The U.S. House of Representatives voted unanimously to pass a bill (H.R. 6433) that would allow FDA to collect newly enacted generic drug user fees. The bill does not include a provision that would allow FDA to collect new biosimilar user fees.

Last week, the House of Representatives passed a continuing resolution that would extend funding at current levels for government operations but omitted technical language that would have allowed FDA to benefit from an increase in drug and medical device user fees and to spend the newly enacted user fees for biosimilars and generics. The Senate is expected to vote on the continuing resolution, H.J. Res. 117, either late Thursday or this weekend. ...