Prescription Drug User Fee Act (PDUFA)

PDUFA will expire in September 2017!

This fight is for all of us.

In recent decades, the U.S. has made incredible progress in the fight against autoimmune diseases. But we still have a long way to go: today, more than 50 million people in our country are living with at least one autoimmune disease, and the prevalence is rising.

Autoimmune diseases occur when the immune system attacks the body’s own organs, tissues, and cells. They were first recorded by researchers in the early 1900s, and since then more than 80 different types have been identified, including diabetes, lupus, rheumatoid arthritis, MS, and celiac disease. These diseases are chronic and often life-threatening. Beyond the autoimmune connection, many of them have unknown causes, and cures have yet to be discovered.

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to supplement Congressional funding in order to ensure the timely review of new medicines. With these additional resources, the FDA was able to enhance the drug review process, ultimately enabling innovative, safe, and effective drugs to reach patients more quickly.

For nearly 25 years, the Prescription Drug User Fee Act (PDUFA) has helped increase the number of treatments available to autoimmune disease patients while researchers and scientists search for cures. And with more than 300 medicines in the pipeline for autoimmune diseases, it will be critical that FDA is equipped to keep up with the rapid pace of treatment innovation.

Every five years, PDUFA must be reviewed and reauthorized by Congress. PDUFA will expire in September 2017.

For the millions of Americans like Kim, Stacey, Katie, and Jim, who are living with autoimmune diseases, the reauthorization of PDUFA this year may mean the availability of new and innovative treatments. In addition, PDUFA reauthorization could mean the difference between life and death for millions of other patients with life-threatening diseases such as HIV/AIDS and cancer.

With the help of PDUFA VI, the United States continues to be a global leader in the discovery and delivery of innovative, safe, and effective medicines. This year, Congress must reauthorize PDUFA to ensure progress continues in the pursuit of cures. Now is the time to act.