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.
By law, PDUFA must be reauthorized every five years. And it’s no less important today than it was in 1992. As the sponsors of the most recent version of the bill, Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.), have pointedly put it: “This bill can literally save lives by ensuring that Americans have access to crucial medicines and medical devices.”
If PDUFA reauthorization is delayed, tens of millions of dollars in FDA financing would evaporate. Hundreds of staffers would be laid off. The approval process would take substantially longer. And patients would have to suffer through punishing new lag times before accessing needed drugs.
Unfortunately, there are some anti-PDUFA forces. They’re convinced the FDA is just an extension of the pharmaceutical industry and that this bill further cements that unholy alliance.
But there’s zero evidence that such a relationship exists. If PDUFA was just a means of the drug industry bribing FDA for approval of sub-par products, there would have been a steady rise in approval rates since PDUFA first passed.
In fact, the opposite has happened. In 1992, 78 percent of late-stage drugs were approved. By 2006, the figure had fallen to 57 percent. Today, it stands at 45 percent.
The FDA has gotten more — not less — rigorous since user fees were established. These resources are helping to speed up the decision-making process. The agency is moving much quicker — without any compromises in patient safety.
There are an estimated 300 high-tech pharmaceutical treatments currently being developed by the American drug industry. They’re aimed at a host of conditions, including asthma, cancer, herpes, malaria and Alzheimer’s disease.
If private firms finish one of these new drugs — and it’s indeed effective and safe — the FDA needs to quickly approve it and get it patients. PDUFA ensures federal officials have the resources they need to do just that.
Congress has already acted in a exceptionally bipartisan fashion to pass this bill. Now, the President needs to sign it.