House Passes FDA Reform Act of 2012; Next Up – Conference Committee

By Kurt R. Karst –      

After a round of congratulatory speeches, 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.  Unlike the U.S. Senate, which passed its version of the bill last week (see our previous post here), the House did not have to slog through a slew of amendments before passing its bill.  The House bill was passed in relatively short order at 7:00 PM.  Accompanying H.R. 5651 is a House Report deatailing the bill’s history and including 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, and create several new provisions of law, among other things.  (The draft performance goals and procedures for each of the user fee pacts are available here, here, here, and here.)

Now that the House and Senate have passed H.R. 5651 and S. 3187 (the FDA Safety and Innovation Act), respectively, focus will move to a conference committee, which will iron out differences between the bills and reach a compromise.  There are many differences between the Senate and House bills – some major and some minor – although the user fee provisions in both bills are almost identical.  The Senate bill includes provisions on drug track and trace, Risk Evaluation and Mitigation Strategies, and changes to the Controlled Substances Act not included in the House bill.  Meanwhile, the House bill includes provisions on generic drug 180-day exclusivity forfeiture, citizen petitions, and drug shortages not included in the Senate bill.  The Congressional Research Service has put together a handy-dandy side-by-side comparison of current law, S. 3187 (as passed), and H.R. 5651 (suspension document).  The expectation among House and Senate leaders is to have a compromise bill voted on and on the President’s desk by the end of June or early July. 

Meanwhile, on May 31st the House Ways and Means Committee is scheduled to mark up H.R. 436, the Protect Medical Innovation Act of 2011.  The bill would amend the Internal Revenue Code of 1986 to repeal the 2.3% medical device excise tax created by the Affordable Care Act that is schedule to take effect in 2013.  According to a report prepared by the Joint Committee on Taxation, the medical device excise tax repeal is in need of a $29 billion offset.  The excise tax has stirred considerable controversy (see here and here) and has played a factor in election year politics, according to Politico. (UPDATE: The Ways and Means Committee voted 23-11 in favor of the repeal – see here.)

REMINDER:  HP&M is hosting a webinar, Garbage Runs, Fake Identities, and Surprise Home Visits; Strategies to Deal With FDA's Nontraditional Investigative Tools, on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET.  Click here to register.