5 Things to Know about PDUFA


When's the last time you brushed up on your health care policy facts? If you're like most Americans, a periodic refresher is in order. For those looking for a deeper understanding of the laws that make our health care system effective, the Prescription Drug User Fee Act (PDUFA) is a great place to start. Haven't heard of it before? Here are five things you should know about this landmark legislation:

  1. It isn't anything new: PDUFA has been around for more than two decades. In fact, Congress will review and likely approve the sixth version of the bill in the fall of 2017. President George H. W. Bush first signed PDUFA into law in 1992. Since that time, Congress has enhanced and reauthorized the legislation five times, occurring once every five years. This consistent review and improvement of the bill ensure its language is updated to reflect contemporary medical advances and suit the needs of all stakeholders, most importantly patients.
  2. It helps regulation keep pace with discovery: Scientists, doctors and researchers are discovering medicines and other new medical treatments at a faster rate than ever seen. Before these crucial discoveries can be made available for those who need them, they must undergo testing and approval. PDUFA gives the Food and Drug Administration (FDA) the resources it needs to keep up with the rapid advancements of today's pharmaceutical industry. In PDUFA VI, I'm hopeful that this progress will expand into previously less-explored areas, such as combination products, where today's testing is often time-consuming.
  3. It gets medicines to patients, faster: Before becoming available for patients, a medicine must clear the full FDA review process. In the past, this process averaged several years--time that many patients couldn't afford to wait for a treatment that could make a huge difference in their recovery or quality of life. Every iteration of PDUFA strengthens the capabilities and efficiency of the FDA, ultimately shortening the time it takes for a treatment to go from the lab to the pharmacy to medicine cabinets across the country.
  4. It ensures patients are heard: Recent PDUFA legislation initiated public forums for the FDA to hear direct feedback as they review the newest scientific options. This presents the opportunity for advocates, caregivers and patients living with a variety of diseases to speak about what's working, and what isn't, to identify how the FDA can help. There has been a strong start, and I'm confident that more will be done to include additional patient advocacy groups in the Patient-Focused Drug Development Initiative and the Benefit/Risk Assessment programs in PDUFA VI.
  5. The next meeting is coming up soon: Before the newest version of the law is approved next year, the FDA will hold several public meetings. The next one will take place on August 15 at the FDA headquarters in Silver Springs, MD. Registration is still open, so you can sign up here if you'd like to attend.

This cornerstone legislation has cleared a path for incredible scientific advances - now it's time again to continue that progress for the next 5 years and beyond. That's exactly what PDUFA I, II, III, IV and V have produced in the last 25 years, and I have no doubt PDUFA VI will do the same.