House Passes FDA User Fee Bill; Congress on Track to Pass Reconciled Bill by Beginning of July

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On May 30, 2012, the U.S. House of Representatives passed the Food and Drug Administration Reform Act of 2012—the chamber’s FDA user fee authorization bill—by a 387–5 margin. With regard to user fees, the bill is very similar to the Food and Drug Administration Safety and Innovation Act (S. 3187), which was approved by the Senate a few days earlier, on May 24, 2012. However, there are substantive differences between the House and Senate bills with regard to provisions that address the FDA’s review and oversight of drugs, medical devices and biologicals. In this newsletter, we provide an overview of some of the major aspects of both bills, and identify similarities and differences between the two pieces of legislation as the two chambers enter the reconciliation process to finalize the legislation for presentation to President Obama.

On May 30, 2012, the U.S. House of Representatives (House) easily passed the Food and Drug Administration Reform Act of 2012 (H.R. 5651), a bill that would reauthorize the Food and Drug Administration (FDA) to assess user fees to support the agency’s review of marketing applications for drugs (including biologicals) and medical devices, and, for the first time, authorize the FDA to collect user fees on generic drugs and biosimilars for five years, beginning October 1, 2012. With regard to user fees, the bill is very similar to the Food and Drug Administration Safety and Innovation Act (S. 3187), which was approved by the Senate last week. (See Senate Easily Passes FDA User Fee Bill, Reconciliation with House Version Looms for more information.)

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