Senator Rick Scott has introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, aiming to improve transparency in the U.S. prescription drug supply chain. The proposed legislation would require prescription drug labels to disclose the original manufacturers of generic drugs and their active pharmaceutical ingredients (APIs).
Currently, many prescription drugs and APIs are produced overseas, particularly in China and India. Existing federal labeling rules do not mandate public disclosure of where these ingredients or finished products originate. This lack of information means that patients, pharmacists, and healthcare providers often do not know where medicines are made.
The CLEAR LABELS Act is designed to address this issue by making it mandatory for drug labeling to include information about the origin of both the drugs and their components. Senator Scott said, “Families want to feel safe; they want to know the drugs they take are safe, and they want to support American companies and American jobs. It is alarming just how many medicines Americans depend on are made overseas, in places like Communist China and India with limited transparency and oversight, leaving patients blindsided about where their drugs come from and unknowingly putting themselves at increased risk of death. My CLEAR LABELS Act takes a commonsense approach to fix that by requiring clear disclosure of the original manufacturers of these drugs and their components, known as APIs. Transparency is critical to protecting patient safety, strengthening oversight, and reducing America’s overreliance on foreign drug production. Americans deserve to have confidence that the medicines they take are safe, regulated, and clearly labeled.”
This legislative effort builds on previous bipartisan work led by Senator Scott during his tenure as chairman of the U.S. Senate Special Committee on Aging. That work included an investigative report as well as more than a dozen inquiries directed at federal agencies and industry leaders regarding reliance on foreign-manufactured generic drugs.
