Washington, Feb 7
Two US senators from rival parties introduced legislation this week that would require prescription drug labels to disclose where medicines and their key ingredients are made, a move aimed at increasing transparency in a supply chain heavily reliant on overseas manufacturing.
US Senators Seek Drug Origin Democratic Senator Kirsten Gillibrand and Republican Senator Rick Scott said the proposal would help patients, pharmacists and doctors better understand the origins of the drugs they use every day.
The bill is called the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act, or the CLEAR LABELS Act. It would add new country-of-origin disclosure requirements to prescription drug labels in the United States.
"Americans deserve to know where their prescription drugs are manufactured so they can make informed health care decisions," Gillibrand said. She said the legislation would make manufacturing information readily available and strengthen accountability across the pharmaceutical supply chain.
Gillibrand added that the measure would support access to "safe, effective, lifesaving medications" by giving patients and providers clear and reliable information.
Scott said families are currently left without basic details about where their medicines come from.
"As parents and grandparents, we do everything we can to make informed, safe decisions that keep our families safe and healthy," Scott said. "But right now, families are being kept in the dark about where their drugs are coming from."
Scott said the United States depends heavily on foreign countries for the production of drugs and active pharmaceutical ingredients, or APIs. He cited China and India as major manufacturing hubs and said limited transparency and oversight create risks for patients.
"This broken process leaves patients in the dark about where their drugs come," Scott said. "Families deserve to have confidence that the medicines they take are safe, regulated, and clearly labeled."
Many prescription drugs sold in the United States, along with their APIs, are manufactured overseas. Current federal labeling rules do not require public disclosure of where those ingredients or finished products are produced. As a result, patients, pharmacists and health care providers often lack visibility into the origins of medications.
The CLEAR LABELS Act would require prescription drug labels to identify the original manufacturers of finished drugs and APIs. The information could appear directly on the label or be made available through a link, barcode or QR code connected to a searchable electronic database.
The senators said the goal is to give patients and regulators clear, upfront information about where medicines are made. They argue that transparency is a first step toward identifying weaknesses in the drug supply chain and preventing threats to the availability of safe and effective treatments.
The legislation builds on earlier bipartisan efforts by Gillibrand and Scott. Those include an investigative report and more than a dozen inquiries to federal agencies and pharmaceutical industry leaders seeking details on US reliance on foreign-made generic drugs.
If enacted, the bill would amend the Federal Food, Drug, and Cosmetic Act to expand labeling requirements and increase disclosure across the prescription drug supply chain.
- IANS
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