House Passes FDA Reform Act of 2012

The U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. The U.S. Senate had already passed its version of the bill. See previous post and here. This House Report explains the bill’s history and includes a section-by-section analysis. Both bills reauthorize and amend old (PDUFA and MDUFA) and establish new (GDUFA and BsUFA) user fee statutes, permanently reauthorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.  Next, a conference committee will reconcile differences between the House and Sentate bills. The Senate bill contains provisions, not included in the House bill, such as provisions on drug track and trace, Risk Evaluation and Mitigation Strategies, and changes to the Controlled Substances Act.  The House bill contains provisions on generic drug 180-day exclusivity forfeiture, citizen petitions, and drug shortages not included in the Senate bill. The Congressional Research Service has a side-by-side comparison of current law, S. 3187 and H.R. 5651. After the committee reaches a compromise on differences in the House and Senate bill, the legislation will be sent to the President for his signature.  This is expected to happen by the end of June or early July.