PDUFA V: Road to Implementation

Speeding safe and effective medicines to patients begins with smart policy. Over the last 20 years, the Prescription Drug User Fee Act (PDUFA) has played a key role in ensuring that the FDA reviews potential treatments quickly and efficiently so that people across the country can benefit from new breakthroughs. In 2012, President Obama signed the fifth reauthorization of PDUFA into law as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Now that the FDA has spent over a year and a half implementing its PDUFA V goals, take a look at our interactive timeline to view the progress made so far.

As you can see, each element of PDUFA plays an important role in the development of patient-centered medicine. For example, a renewed focus on benefit-risk assessment enables FDA to gather patient viewpoints on the benefits and risks of potential new medicines, and to integrate those perspectives into its review process and decisions. PDUFA V also bolsters the FDA's rare disease expertise, ensuring that it has the resources needed to streamline the review of new treatments for rare disease patients.

So far FDA has made substantial progress, but there's still work to be done. For example, although the FDA has gathered a lot of meaningful information during its six meetings on disease states so far, it is still unclear how the FDA plans to utilize this data and incorporate it into agency decision-making. We eagerly anticipate the FDA's proposal on how it will incorporate these perspectives into its decision-making process. Additionally, the FDA should give patient groups a clear perspective on what types of data it might find useful during the review of new medicines and treatments. Incorporating patient feedback can help better inform the FDA's decisions on current and future review decisions for all diseases.

With these efforts, PDUFA V encourages a more effective, patient-centered process and promotes timelier access to medicines that can help people lead longer, healthier lives. We look forward to seeing how the FDA continues to implement this important program.