Senate/House Conference On FDA/PDUFA Bill

The US House and Senate versions of the Food and Drug Administrationreform/Prescription Drug User Fee Act reauthorization bill differ with respect to the PDUFA trigger, as well as in other areas, sources have told the Marketletter, but these will be resolved in the joint conference committee.

The White House is still unhappy with Senate requirements for the entire FDA budget to rise annually, indexed to inflation, before it can collect user fees, saying this would undercut the bipartisan budget agreement by requiring FDA budget growth not envisioned by the BBA and interfere with Health and Human Services' ability to allocate resources appropriately, reports Health New Daily. The Office of Management and Budget is reportedly seeing if a proposal is acceptable to tie only the Centers for Drug Evaluation and Research and for Biologics Evaluation and Research funding to inflation, thus eliminating the need to raise funding for the whole agency. House Commerce Committee Ranking Minority Member John Dingell feels these objections are easily resolvable, saying the bill has carefully protected the monies that go into FDA operations from manufacturers and others, so that they are not diverted.

The House bill's antibiotic exclusivity provisions will also be worked out in conference. Representative Peter Deutsche says any extra exclusivity must be limited very narrowly to the challenge of resistant strains. He introduced an amendment at subcommittee and full committee mark-up of HR 1411 to limit the application of market exclusivity provisions for antibiotics and insulin products by excluding products for which the largest clinical trial had commenced at the bill's enactment, reports Health News Daily. The bill's summary says the issue was not resolved and promises another look in conference.