PDUFA Final Legislation: House Pays For Senate’s GAIN
This article was originally published in The Pink Sheet Daily
Executive Summary
Resolution of issues in conference committee largely favors the brand industry, and swift passage will allow the legislation to avoid becoming a political football after the Supreme Court’s ruling on health care reform.
The brand pharmaceutical industry has won most of the battles fought during the conference committee on the user fee bill and now seems poised to achieve its highest legislative priority for the year – a smooth, early reauthorization of PDUFA.
House and Senate negotiators released the final text of the legislation the evening of June 18, and are hoping that both chambers pass the bill – which will reauthorized the prescription and medical device user fee programs and create programs for generic drugs and biosimilars – within the week. That timetable would prevent the bill from becoming a political football after the Supreme Court’s ruling on health care reform, which is not expected before June 25.
The legislation had moved remarkably smoothly through each chamber, but the process left a number of issues to be hatched out in conference (Also see "User Fee Conference Cmte. Could Be Relatively Messy After Clean Floor Votes" - Pink Sheet, 4 Jun, 2012.). In the only true disappointment for the brand pharmaceutical industry, one of them remained unresolved, and drug distribution language was left out of the bill after a compromise could not be reached (Also see "Track-And-Trace Will Not Hitch A Ride On The User Fee Train" - Pink Sheet, 18 Jun, 2012.).
The only other area where the brand pharmaceutical industry did not appear to prevail in conference was antibiotic exclusivity, where the Senate’s less expansive language carried the day. But the creation of an additional five-year exclusivity for a therapeutic category, even if not as broadly defined as it could have been, can hardly be considered a legislative defeat.
Brand pharma unquestionably won the highest profile fight of the conference committee, how to pay for the legislation. The House language – which would speed review of citizen petitions that might block approvals of generics and biosimilars – was adopted in favor of the Senate language, which would have ensured generic access to REMS products for testing and development of ANDAs and 351(k) applications (Also see "PDUFA Negotiations: REMS Mud-Slinging, Supply Chain Compromising, GAIN Diminishing?" - Pink Sheet, 18 Jun, 2012.).
Another area that was subject to public letter-writing campaigns during the conference negotiations was language in the Senate bill that would tighten the scheduling of pain medicine hydrocodone. The effort was opposed by pharmacy and generic groups, and as expected, the section was dropped in favor of instructions that FDA convene a meeting to consider the issue (Also see "Hydrocodone Gets Advisory Committee Review, Offering Congress A Scheduling Out" - Pink Sheet, 7 Jun, 2012.).
On one final crucial question of the legislation, the Senate prevailed: The bill will become known as the FDA Safety and Innovation Act of 2012, with the Senate’s six-letter acronym, FDASIA, besting the House’s five-letter entry FDARA, which stood for the FDA Reform Act.