Every five years, Congress revises the Prescription Drug User Fee Act (PDUFA) to modernize the development, review and delivery of new medicines in the United States. PDUFA provides the FDA with the financial and human resources it needs to more efficiently assess applications for new medicines. Each version of the law builds upon an already-solid foundation, continuing a trend of constant improvement to an essential facet of public policy. As we approach the sixth reauthorization of PDUFA, I think it's a good time to examine the numbers behind this law.
Prior to PDUFA I passing in 1992, the regulatory environment did not favor the quick discovery and development of new medical treatments. Lengthy review times and disjointed processes meant medicines could take a long time to get to patients, or become available in other countries before the U.S. But now, these issues are a thing of the past:
The need for PDUFA stemmed from the considerable amount of time between a medicine's initial discovery and approval and availability to the public. Often spanning many months or even years, it lasted far longer than most patients could bear. In the years preceding PDUFA, the review period for standard (non-priority) products averaged 22 months. However, the new law changed that:
To keep up with the ever changing public health landscape and varying needs of American patients, Congress authored and approved four subsequent iterations of PDUFA. From increased staffing to supplemental funding, each version shaped a new era of pharmaceutical development and oversight. Thanks to PDUFA, we've come a long way since the days of inadequate health outcomes and drawn-out approvals:
PDUFA paves the way for tremendous progress, but it's time to propel the momentum even further and ensure all patients have access to treatments they need. Patients and researchers will always benefit from a more transparent and efficient development and review process. This is what PDUFA has delivered in the past, and what PDUFA promises to deliver in 2017 and beyond.