Last night, the Senate voted to pass the Food and Drug Administration Safety and Innovation Act (S. 3187), reauthorizing the Prescription Drug and User Fee Act (PDUFA) for a fifth time. As I have said before, PDUFA is an important piece of legislation, designed to improve the speed, safety, and efficacy of the drug review process at the FDA, ultimately bringing new medicines to patients faster.
In a statement released yesterday, John C. Lechleiter, our chairman and CEO, highlighted the impact of PDUFA:
"Since its inception in 1992, PDUFA has enabled the FDA to shorten review time from new drug applications by 60 percent. As a result, patients in the U.S. have had speedier access to more than 1,500 new medicines to treat medical conditions such as cancer, diabetes, cardiovascular disease, and neurological disorders."
Along with making the review process more timely, balanced, and efficient, the latest reauthorization of PDUFA will also strengthen framework for evaluating the benefits and risks of new treatments. This update to current law will greatly improve the ability to deliver the most effective treatments for patients.
With this vote, the Senate joined the House in showing broad bipartisan support and reaffirming the value of PDUFA for the future of medical innovation. Here at Lilly, we look forward to the President's signature on this vital piece of legislation. As Dr. Lechleiter said, "PDUFA will keep our nation at the forefront of medical innovation and allow us to continue delivering new medicines that help patients live longer, healthier, and more productive lives."