WASHINGTON – U.S. Senators Maggie Hassan (D-NH) and Rand Paul (R-KY) introduced bipartisan legislation to streamline the approval process for generic drugs, which will help get more generics into the market quicker, helping lower prescription drug prices for consumers. Representative Annie Kuster (NH-02) introduced the House version of the bill earlier this year.
“High prescription drug prices are hurting Americans’ bottom lines and forcing some to make the impossible decision between buying their medications or other necessities,” said Senator Hassan. “This bill will streamline the approval process for more affordable, generic drugs, so that Granite Staters and all Americans can better afford the medications that they need. I will continue working across the aisle to bring down prescription drug costs.”
“No one should have to play a complicated guessing game with the FDA simply to bring a safe, effective, and affordable drug to market. The Increasing Transparency in Generic Drug Applications Act will help low-cost generics get to American consumers faster,” said Dr. Paul.
Currently, the FDA requires certain generic drug manufacturers to demonstrate that they have the same active and inactive ingredients in the same concentration as the reference brand name drug. However, when a generic drug contains the wrong amount of inactive ingredient, the FDA cannot disclose the exact error, forcing manufacturers to engage in an often lengthy guessing game to reach the right balance. This legislation would require the FDA to more clearly identify the specific differences between the generic and brand name drug, thereby streamlining the approval process, helping more generics reach the market faster, and lowering prescription drug prices overall.
Senator Hassan is working to lower health care costs for Granite Staters, including by pushing to allow Medicare to negotiate drug prices. In addition, Senator Hassan led successful, bipartisan efforts with Senator Bill Cassidy (R-LA) to help end the practice of surprise medical billing, which is now in effect. They also successfully passed into law their bipartisan legislation to enhance education about biosimilar drug products in an effort to increase competition and lower drug costs.
To see the bill text, click here.