WASHINGTON – Today, the president signed into law bipartisan legislation, the Ensuring Innovation Act, introduced by U.S. Senators Bill Cassidy, M.D. (R-LA), Tina Smith (D-MN), and Roger Marshall, M.D. (R-KS) 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.
“Listening to patients and people back home, I hear the need to lower the price of prescriptions and that’s the goal. This bill saves money for both patients and taxpayers. We’re closing a loophole so now generics can enter the market, drug prices can fall and it benefits the patient’s pocketbook as she’s taking medication to benefit her health,” said Dr. Cassidy.
“We need to stand up for Americans who are being hurt by the skyrocketing costs of prescription drugs,” said Senator Smith. “Far too often I hear from families who are being forced to make the impossible decision of choosing between life-saving prescription drugs and other necessities like groceries or rent. That’s why I teamed up with Sen. Cassidy to introduce the bipartisan Ensuring Innovation Act, which will stop big pharma from keeping drug costs high by unfairly extending monopolies. I’m glad that President Biden signed this legislation into law today and I’ll keep fighting to drive down prescription drug costs for consumers.”
“As a physician, 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. I’m pleased my first bill as a U.S. Senator to be signed into law ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine.”
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.
If a company invents an innovative new drug, they are rewarded with exclusive right to sell that drug for a period of time. However, companies have found loopholes to claim new innovations on the same drug, that aren’t really innovations, to extend their exclusivity and prevent cheaper generics from coming to market. The Ensuring Innovation Act would close loopholes to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generics from entering the market.
Introduced in February, the Ensuring Innovation Act passed the Senate on March 10, 2021 by unanimous consent. It passed the House of Representatives on April 14, 2021 by voice vote.
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