March 14, 2023

WASHINGTON, D.C. – Today, U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts. The bipartisan Increasing Transparency in Generic Drug Applications Act would help get generic medications onto the market faster and lower prescription drug prices for consumers.

“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.

“Expanding access to generic medications is a commonsense way to help families save money,” Senator Hassan said. “Our bipartisan bill will cut unnecessary red tape to help get low-cost generic medications onto the market and into the hands of patients more quickly. I will keep working across the aisle to help lower health care costs and make medications more affordable for families.” 

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.

You can read the Increasing Transparency in Generic Drug Applications Act HERE.


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