PDUFA: Seeking a more efficient drug review process

The US Congress must reauthorize PDUFA by September.

Sarah Kliff of the Washington Post has an instructive story up about the Prescription Drug User Fee Act – also known as PDUFA – and why it is important.

Kliff writes:

Right now, there’s a big health policy battle brewing on the Hill. It’s not about Obamacare. It has nothing to do with repeal — and everything to do with PDUFA, a very important law with a very funny name.

Try and get past the quirky acronym, which sounds more like a children’s cartoon character than a crucial piece of health policy. Because PDUFA is actually quite serious. It stands for the Prescription Drug User Fee Act. It generates the vast majority of the federal government’s budget for reviewing new medications. And so it plays a huge role in determining how safe our health-care system is, and how quickly we get access to new drugs.

PDUFA was first enacted in 1992 and authorizes the US Food and Drug Administration to collect fees from biopharmaceutical companies to help pay for the regulatory review process of medicines and biological products.

It was renewed in 1997, 2002 and 2007. The law paid for $573 million in drug review costs in fiscal year 2010. That accounts for 62 percent of the review costs for that year, according to the FDA’s most recent PDUFA financial report.

The law, however, is set to expire and must be reauthorized by September. More from Kliff:

Among all the players on PDUFA, there’s pretty widespread agreement that this is a fee that pharmaceuticals should be paying. It’s a law that nearly everyone, from Republicans to Democrats to industry, thinks is working. PhRMA’s David Wheadon describes it as a “great success for patients.”

The question, now, is whether Congress can keep the law working. PDUFA doesn’t make many headlines. But it’s the one piece of must-pass health policy legislation in 2012. Legislators have about five months, and a lot of details to sort out.

Because AstraZeneca stands for a strong, well-funded and well-managed FDA, we support a timely reauthorization of PDUFA that provides much needed resources to the agency.

We hope that the resulting legislation will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.

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