Marshall, Colleagues Introduces Bill to Strengthen Pipeline, Lower Costs for Key Prescription Drugs

(Washington, DC, June 3, 2022) — U.S. Senator Roger Marshall, M.D. (R-KS) joined Senators Tim Kaine (D-VA), Bill Cassidy (R-LA), and Maggie Hassan (D-NH) in introducing the Biologics Market Transparency Act (S. 4302). This bipartisan legislation would give 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.”

“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 Senator 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 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 Senator Cassidy.

Background:

Under current law, prescription drug manufacturers must notify the FDA if they withdraw a drug from the market. The publication, Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, provides important information to generic drug developers and providers. Generic drug developers use the Orange Book to learn when patents and exclusivities expire. Physicians use it to learn about drug substitution and if other equivalent therapeutics could be appropriate for their patients and more.

The Purple Book is intended to be the equivalent resource but for biological which are more complex and are used to treat life-threatening diseases. However, current law does not require biologics applicants to notify the FDA if a biologic or biosimilar is withdrawn from the market. This means that for products like insulin, the FDA and health care providers are not able to determine what products are actively being marketed and available to patients.

The bipartisan Biologics Market Transparency Act would require applicants of biologics and biosimilars to notify FDA of changes related to the status of these medicines. This would increase transparency in the drug market by requiring manufacturers to share information with the FDA regarding when their biologics are coming off the market.

The legislation has been included in the HELP Committee’s bipartisan reauthorization of the FDA user fee programs, the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348). The Committee is expected marked up the package on Wednesday, June 8, 2022.

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