This week, U.S. Senators Kirsten Gillibrand (D-NY) and Rick Scott introduced legislation—the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act—to add country of origin labeling requirements to the U.S.’s prescription drug supply chain.
“Americans deserve to know where their prescription drugs are manufactured so they can make informed health care decisions,” said Senator Gillibrand. “The CLEAR LABELS Act would shine a light on pharmaceutical manufacturing by making this information readily accessible to patients, pharmacists, and providers while strengthening accountability across the supply chain. As the top Democrat on the Senate Aging Committee, I will keep fighting to make sure every American has access to safe, effective, lifesaving medications and the clear, reliable information they need.”
“As parents and grandparents, we do everything we can to make informed, safe decisions that keep our families safe and healthy,” said Senator Rick Scott. “But right now, families are being kept in the dark about where their drugs are coming from. America’s drug supply is dependent on our enemies like China and countries such as India to manufacture our drugs and ingredients, often with limited transparency and oversight. This broken process leaves patients in the dark about where their drugs come. Families deserve to have confidence that the medicines they take are safe, regulated, and clearly labeled. That’s why I’m leading the bipartisan CLEAR LABELS Act with Ranking Member Gillibrand to add country of origin labels to your medicines and help ensure every American can feel comfortable knowing what’s in their medicine cabinet.”
Many prescription drugs, and their active pharmaceutical ingredients (APIs), are manufactured overseas, particularly in China and India. However, current federal labeling requirements do not require public disclosure of where those ingredients or finished products are made. As a result, patients, pharmacists, and health care providers lack visibility into the origins of their medications. Transparency is the first step in determining vulnerabilities in the drug supply chain to prevent threats to the availability of safe and effective medications for American patients.
The CLEAR LABELS Act would require prescription drug labels to disclose the original manufacturers of prescription drugs and APIs to ensure patients, providers, and regulators have clear, upfront information about where the drugs they rely on day after day are made.
This legislation builds on bipartisan efforts led by Chairman Scott and Ranking Member Gillibrand, including an investigative report and more than a dozen inquiries to federal agencies and industry leaders requesting information on the U.S.’s dangerous overreliance on foreign-manufactured generic drugs.
The full text of the CLEAR LABELS Act can be found here.
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