Strengthening the FDA’s Approval Process and Boosting Transparency in Drug Market Would Lower Costs, Increase Competition, and Expand Treatment Options
Washington, D.C. – U.S. Senator Susan Collins (R-ME), a member of the Senate Health Committee, joined Senators Tim Kaine (D-VA) and Maggie Hassan (D-NH) in introducing legislation to strengthen the FDA approval process pipeline and increase transparency for critical medicines, which would lower costs and increase availability of key medications.
“Millions of Americans are struggling with the high cost of prescription drugs, making it more and more difficult for them to access the treatments they require. This problem particularly affects our seniors, 90 percent of whom take at least one prescription drug,” said Senator Collins. “By streamlining the FDA’s approval process for interchangeable biosimilars, our bipartisan legislation would make it easier for pharmaceutical manufacturers to enter the market and offer low-cost competitors. This ultimately will help to strengthen the drug supply chain, increase transparency, and reduce the cost of lifesaving medications.”
The Interchangeable Biologics Clarity Act 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.
Click HERE to read the bill text.
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