Josh Bloom, MedCity News July 3, 2012, "Mr. President, sign that user fee bill"
It s not often Congress acts in a genuinely bipartisan fashion. When it does, there s almost certainly a serious national interest at stake.
And genuine bipartisanship was in full effect a few weeks ago when the House of Representatives voted by a stunning 387-to-5 margin to pass a piece of legislation reauthorizing the Prescription Drug User Fee Act, or PDUFA.
Just days before, the Senate passed its version of the bill. In conference, lawmakers ironed out the minor differences between their two bills and now, it heads to the President s desk. Party leaders have said they hope to present President Obama with a final bill by July 4.
It s critical for the President to sign this measure quickly. Doing so will ensure patients continue to have access to top-flight, lifesaving medicines.
PDUFA was first passed back in 1992, when the Food and Drug Administration (FDA) was severely underfunded and understaffed. At the time, even though the agency was supposed to review new medicines within 180 days, it often took two years or more for a drug to make it through the review process.
Lawmakers addressed this issue by requiring drug companies to pay user fees to the FDA when submitting treatments for approval. The fees would help finance FDA review by providing adequate funding for staff and related resources. And it put the financial burden on drug makers, not taxpayers.
This was a smart move.
Shortly after PDUFA passed, the FDA expanded its review staff dramatically. The results have been nothing short of spectacular. The average review time has been cut in half. And patients have benefited from having quicker access to new treatments that can extend and enhance their lives...[Read more].