Marshall, Cassidy, Smith Legislation to Lower Prescription Drug Costs Passes Senate

(Washington, D.C., March 11, 2021) – The U.S. Senate last night passed the Ensuring Innovation Act, which was introduced by U.S. Senators Roger Marshall, M.D., Bill Cassidy, M.D. (R-LA), and Tina Smith (D-MN) last month to 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.

“As a physician, and now a U.S. Senator, 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.”

Background:

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.

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