The House Energy and Commerce Committee Wednesday approved legislation that would authorize a user-fee program for Food and Drug Administration reviews of animal medications.
The Animal Drug User Fee Act (H.R. 1260), which passed by voice vote, without amendment, is similar to the Prescription Drug User Fee Act that was enacted in 1992. In this case, applications for FDA review of new animal drugs would have to be accompanied by payment of a substantial fee to help pay for and expedite the review process. The bill sets the user fee for an application at $1.25 million for fiscal year 2004, $2 million for fiscal 2005, and $2.5 million for fiscal 2006, 2007, and 2008.
The bipartisan bill received no significant criticism from Democrats, although Rep. Henry Waxman, D-Calif., asserted that user fees alone are not sufficient to support the FDA review process, which he said "has been underfunded for several years." Congress must appropriate the full amount needed to supplement the money generated by the fees, Waxman said.
Committee Chairman W.J. "Billy" Tauzin, R-La., informed Waxman that he had spoken to House Speaker Dennis Hastert, R-Ill., and assured Waxman that he had "the Speaker's word" that appropriators would be able to make up the difference needed to cover the costs of the review process.