WASHINGTON – U.S. Senators Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Lee (R-UT) reintroduced bipartisan legislation to streamline the approval process for generic drugs, which will help generics enter the market more quickly and lower prescription drug prices for patients. Last Congress, this legislation advanced from Committee with a bipartisan 19-2 vote.
“Skyrocketing prescription drug prices are forcing too many Granite Staters to choose between their health and their financial security,” said Senator Hassan. “This commonsense, bipartisan legislation will help address a critical obstacle in the generic drug approval process that keeps affordable alternatives off of pharmacy shelves. By requiring more transparency from the FDA and streamlining the drug approval process, this bill will help deliver lower-cost medications to Americans faster.”
“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.
“More generic drugs means lower health care costs for Americans. Unnecessary and unclear FDA approval processes delay them from reaching the shelves,” said Senator Hickenlooper. “Our bill speeds up the process to help Americans save more.”
“Generic drugs have made the prescription drug market much more competitive, offering cheaper alternatives to their brand name counterparts. Streamlining the generic drug approval process by eliminating the pointless guessing game manufacturers are forced to play would eliminate red tape and bring down costs for American families,” said Senator Lee.
“S. 1302 expedites generic submission by creating process efficiencies for FDA and Industry. These efficiencies will enhance patient access to lower-cost medicine. When generic medicines become available, they bring immediately lower prices for lifesaving and lifechanging medications. We are thankful for the work done thus far by Senators Hassan, Paul, Hickenlooper, and Lee,” said John Murphy, III, President & CEO for the Association for Accessible Medicines.
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 ingredients, 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 more quickly, and lowering prescription drug prices overall.
This measure is part of Senator Hassan’s ongoing efforts to lower health care costs for Americans. Senator Hassan previously led successful bipartisan efforts to help eliminate surprise medical billing, which has prevented millions of surprise bills. Senator Hassan also helped pass into law three bipartisan measures to increase access to generic and biosimilar medications. Additionally, Senator Hassan successfully pushed to cap insulin costs for those on Medicare as part of the Inflation Reduction Act, which became law in 2022.
###