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Kaine, Colleagues Introduce Bills to Strengthen Pipeline, Lower Costs for Key Prescription Drugs

Strengthening the FDA’s approval process, boosting transparency in drug market would lower costs, increase competition, expand treatment options

WASHINGTON, D.C. — Today, U.S. Senator Tim Kaine (D-VA), who serves on the Senate Health, Education, Labor, and Pensions Committee, teamed up with bipartisan groups of colleagues to introduce two pieces of legislation to strengthen the pipeline and increase transparency for critical medicines, which would lower costs and make it easier for physicians and patients to plan for the future.

“Virginians with serious medical conditions should be focused on their well-being, not worrying about whether they’re going to be able to pay for their medicine,” said Kaine. “Strengthening the FDA’s approval processes will help make as many safe, effective treatment options available for patients as possible, while increasing transparency regarding drugs that leave the market will give folks the information they need to plan ahead. I look forward to working with my colleagues to get these bipartisan bills across the finish line and lower costs for Virginia families.”

The Interchangeable Biologics Clarity Act, which Senator Kaine introduced with Senators Susan Collins (R-ME) and Maggie Hassan (D-NH), 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.

“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.”

“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 Biologics Market Transparency Act, which Kaine introduced with Senators Roger Marshall, M.D. (R-KS), Maggie Hassan (D-NH), 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.

“As a physician, I can attest to the importance of having up-to-date information on available medicine before my patient and I decide on a treatment course,” said Senator Marshall. “Physicians and other health care providers have up-to-date information on available prescription brand name drugs and generics. However, we don’t have that for biologics and biosimilars – medicines which are incredibly more complex and are used for treating debilitating and life-threatening diseases. Our commonsense, bipartisan legislation fixes that knowledge gap so health care providers will always know about all available options to help pick a treatment that works best.”

“The United States has the greatest drug development and innovation capabilities in the world. While encouraging investment in lifesaving drugs, we must also support competition and help bring low-cost options to market. Our bill ensures FDA has information to improve the system and promotes low-cost drugs for patients,” said Dr. Cassidy.

Full text of the Interchangeable Biologics Clarity Act is available here. Full text of the Biologics Market Transparency Act is available here.