Strengthening the FDA’s Approval Process and Boosting Transparency in Drug Market Would Lower Costs, Increase Competition, and Expand Treatment Options
WASHINGTON —U.S. Senator Maggie Hassan, who serves on the Senate Health, Education, Labor, and Pensions Committee, is teaming up with a bipartisan group of colleagues to introduce two pieces of legislation to strengthen the FDA approval process pipeline and increase transparency for critical medicines, which would lower costs and increase availability of key medications.
“While Big Pharma makes record profits, it is everyday Americans who foot the bill,” said Senator Hassan. “We must increase transparency as part of our broader efforts to stand up to Big Pharma and bring down prescription drug prices across the board. These bipartisan bills will take commonsense steps to help increase access to affordable medication and prevent price spikes -- I urge my colleagues on both sides of the aisle to move forward on these bills.”
The Interchangeable Biologics Clarity Act, which Senator Hassan introduced with Senators Tim Kaine (D-VA) and Susan Collins (R-ME), would more efficiently usher drugs to the market by making key improvements to the Food and Drug Administration’s (FDA) review process for interchangeable biosimilars. Interchangeable biosimilars are drugs that can be substituted for an existing biologic and are prescribed to treat a wide variety of diseases and conditions such as diabetes, arthritis, and cancer. The legislation would provide the FDA with clarity around exclusivity periods for interchangeable biologic products, allowing products that can easily be substituted to treat the same condition to enter the market faster.
The Biologics Market Transparency Act, which Senator Hassan introduced with Senators Tim Kaine (D-VA), Roger Marshall, M.D. (R-KS), and Bill Cassidy (R-LA), would increase transparency in the drug market by requiring manufacturers to share information with the FDA regarding when their biologic drugs are coming off the market—giving physicians and patients critical information they need to make treatment decisions that are best for them, including helping plan for potential drug shortages.
Senator Hassan is working across the aisle to stand up to Big Pharma and lower health care costs for Granite Staters. Senator Hassan has pushed 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. Senators Hassan and Cassidy 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.
Full text of the Interchangeable Biologics Clarity Act is available here. Full text of the Biologics Market Transparency Act is available here.
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