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Senators Hassan, Paul Introduce Bipartisan Bill to Lower Health Care Costs by Streamlining Generic Medication Approval Process

WASHINGTON – U.S. Senators Maggie Hassan (D-NH) and Rand Paul (R-KY), 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. Representative Annie Kuster (NH-02), a senior Member of the Energy and Commerce Committee, leads this legislation in the House.

“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.”

“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 leading efforts in the Senate to expand access to low-costs generic medications. The most recent government funding bill, which is now law, included three bipartisan measures back by Senator Hassan to increase access to generic and biosimilar medications. Senator Hassan also recently introduced bipartisan legislation to close loopholes that Big Pharma can exploit to block competition from better alternative drugs, including generic drugs, and keep drug prices high. And Senator Hassan led successful bipartisan efforts to help eliminate surprise medical billing, which has prevented at least 9 million surprise bills. 

To see the bill text, click here.