This year's progress, to date, of reauthorization of the Prescription Drug User Fee Act is a testament to the resounding success of the PDUFA program. By providing the Food and Drug Administratio with needed resources, PDUFA has helped FDA operate in a more efficient way, dropping the median review time from 29 months in 1991 to approximately 13 months in fiscal 2010. At the same time, since PDUFA was first passed in 1992, roughly 1,500 new medicines have been brought to the patients who need them.

We all know – or will know – family members, friends, and colleagues who need new, cutting-edge medicines to improve or save their lives. Ensuring that patients have timely access to the latest therapies isn’t a partisan goal, it’s a personal goal and a public health goal. Hence the bipartisan support for this critical legislation.

In fact, this year also calls for the reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) – programs that have encouraged increased research into the use of medicines in children, helping us make significant advances in the care that children receive. This year, there is strong bipartisan support not just for reauthorization of BPCA/PREA, but for permanent reauthorization of these patient-focused programs.

It's also important to recognize that this PDUFA cycle has been facilitated by the strong foundation of the FDA performance goals letter. By conducting the most collaborative, transparent negotiations in history, and by including input from a wide variety of stakeholders, the FDA laid the groundwork for legislation that is constructive and that merits bipartisan support.

This year faces the same strict deadlines as previous cycles. The program sunsets at the end of September, which means it must be reauthorized or it will expire. More importantly, if reauthorization isn't completed by July, the FDA may have to send layoff notices to many hundreds - if not more - of employees. But unlike other PDUFA cycles, this cycle has the added pressure of being in an election year.

Clearly, the emphasis on timeliness from leaders on both sides of the aisle demonstrates that PDUFA isn't only viewed as must-pass - it is viewed as must-pass soon.

The following entry comes from Sen. Michael Bennet, D-Colo.:

From my perspective, someone who’s only been here a few years, this process can be a model for making Washington work.

The conversation we’re having in Washington is too often decoupled from the conversations in my town hall meetings and across the country about the challenges we need to address – the gap is miles apart.

Chairman Harkin and Ranking Member Enzi have run a very good process that has enabled me to be responsive to what Coloradans say they want: a modern FDA, improved patient safety and innovation. We’ve also had committee members interested in rolling up their sleeves and doing hard work together, including working through a mark-up with virtually no partisanship. It has been a singularly and uniquely good process, which has give great momentum toward a full extension. In what I’ve called the land of flickering lights, it’s gratifying to work on something that isn’t a 3 month extension.

This bill still has a ways to go before it becomes law, but to this point it has been a rewarding bipartisan process. I hope we see similar bills follow suit.