WASHINGTON— U.S. Senators Bill Cassidy, M.D. (R-LA), Pat Roberts (R-KS), and Tina Smith (D-MN) today introduced the Ensuring Innovation Act, which will help lower prescription drug prices. The legislation will provide clarity for drug exclusivity to prevent awarding exclusivity to products which do not represent a true innovation and unduly delaying cheaper generics from entering the market.
Currently, the FDA grants five years of exclusivity to drug products that are determined to be New Chemical Entities (NCEs). 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.
“No matter where I go in Louisiana, people are always mentioning the high cost of prescription drugs,” said Dr. Cassidy.“To lower the cost of drugs we need to increase competition and get rid of legal loopholes that prevent getting generics to market faster.”
“This is commonsense legislation that will help keep drug prices down, by making sure exclusivity is only granted to medications that are truly innovative. This will ensure that generic prescriptions are available when they should be,” said Senator Roberts.
“Our bipartisan bill is about standing up for Americans who are struggling to afford life-saving medicine by making it easier for lower-cost generics to come to market,” said Senator Smith.“The Ensuring Innovation Actmakes clear that true innovation means taking steps to make prescription drugs more effective for Minnesotans and all Americans, and focusing on driving down costs for consumers.”