Senators Paul, Hassan, Lee, and Hickenlooper Reintroduce Bill to Lower Prescription Drug Prices by Streamlining Generic Drug Approvals

Washington, D.C. – Today, U.S. Senators Rand Paul (R-KY), Maggie Hassan (D-NH), Mike Lee (R-UT), and John Hickenlooper (D-CO) reintroduced bipartisan legislation to streamline the approval process for generic drugs, which will help expedite generic entrance in the market and lower prescription drug prices for patients. Last Congress, this legislation advanced from the Senate Health, Education, Labor, and Pensions (HELP) Committee with a bipartisan 19-2 vote.

“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.

“Skyrocketing prescription drug prices are forcing too many Granite Staters to choose between their health and their financial security. This commonsense, bipartisan legislation will help address a critical obstacle in the generic drug approval process that keeps affordable alternatives off 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,” said Senator Hassan.

“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.

“More generic drugs means lower health care costs for Americans. Unnecessary and unclear FDA approval processes delay them from reaching the shelves. Our bill speeds up the process to help Americans save more,” said Senator Hickenlooper.

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 identify the specific differences more clearly 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.

You can read it HERE.

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Senators Paul, Hassan, Lee, and Hickenlooper Reintroduce Bill to Lower Prescription Drug Prices by Streamlining Generic Drug Approvals

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