U.S. Senators Bill Cassidy, M.D. (R-LA), Tina Smith (D-MN) and Roger Marshall (R-KS) today introduced the Ensuring Innovation Act, which will help lower prescription drug prices. The legislation will provide clarity for drug exclusivity to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generics from entering the market.
Currently, the FDA grants five years of exclusivity to drug products that are determined to be a New Chemical Entity (NCE). In order to be an NCE, a drug product must contain an “active moiety” that has not been used in a product previously approved by the FDA. This legislation will codify the FDA’s current “active moiety” approach to granting NCE exclusivity.
“We must lower prescription drug costs. We can do this by increasing competition and closing loopholes which prevent generics from reaching the marketplace. This bill does both,” said Dr. Cassidy.
“High prescription drug prices are forcing too many families to choose between the medications they need and other necessities, like groceries or rent,” said Senator Smith. “In this moment, as we navigate the public health and economic crisis of COVID-19, it’s especially important that we stand up for Americans who are struggling to afford life-saving prescription drugs. The bipartisan Ensuring Innovation Act makes clear that true innovation means taking steps to make medications more effective for Minnesotans and all Americans, and focusing on driving down costs for consumers.”
“As a physician, and now policymaker, I believe innovation and competition can have a profound impact on driving down the cost of health care,” said Senator Marshall. “The current regulatory landscape unnecessarily delays patient access to FDA-approved generics. Our bipartisan legislation ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine.”