IU Study Shapes Federal Bill for Drug Label Transparency

New bipartisan legislation would require original manufacturer and supply chain information on prescription drug labels

Mar. 31, 2026 at 3:44am

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Research by an Indiana University faculty member, George Ball, is at the heart of new bipartisan legislation that would amend the Federal Food, Drug and Cosmetic Act to require original manufacturer and supply chain information on prescription drug labels. Ball's research found an increase in adverse events resulting from generic drugs made in India compared to equivalently designed generic drugs made in the U.S., leading to the introduction of the CLEAR LABELS Act.

Why it matters

Ball's research exposed serious concerns about the quality of generic medications produced abroad, highlighting the need for greater transparency in the pharmaceutical supply chain. The proposed legislation aims to provide consumers with more information about where their drugs are made and the quality of those drugs, which could help improve patient safety.

The details

Ball's research, published in the journal Production and Operations Management, found that generic drugs made in India were linked to significantly more "severe adverse events" than equivalent generic drugs produced in the U.S. These adverse events included hospitalization, disability and, in a few cases, death. The study also was the first to link a large sample of generic drugs to the actual plant where they were manufactured. Ball and his co-authors proposed providing country of origin and a quality rating on drug labels as a remedy for the increased offshoring of drug manufacturing and associated quality risk.

  • Ball testified before the U.S. Senate Special Committee on Aging in September 2025 related to his research paper.
  • Ball's colleague testified before the committee in January 2026 on the newer paper that provides the transparency solution.
  • Sen. Rick Scott, R-Fla., introduced the newly proposed bipartisan legislation, Senate Bill 3788, dubbed "The CLEAR LABELS Act" in 2026.

The players

George Ball

An associate professor of operations and decisions technologies and Weimer Faculty Fellow at the IU Kelley School of Business in Bloomington, whose research exposed concerns about the quality of generic medications produced abroad.

Sen. Rick Scott

A Republican senator from Florida who introduced the CLEAR LABELS Act, which aims to improve transparency in the pharmaceutical supply chain.

Sen. Kirsten Gillibrand

The ranking minority member of the U.S. Senate Special Committee on Aging, which held hearings on Ball's research.

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What they’re saying

“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.”

— Sen. Rick Scott, U.S. Senator, Florida

“I believe our research, and particularly our testimony in the Senate, spoke to an important need to improve the transparency of our nation's drug supply chain. Consumers deserve to know where their drugs are made, and the quality of their drug. We expect this level of transparency from the cars we drive, the food we eat and the toys our children play with. We should get it in our pharmaceuticals.”

— George Ball, Associate Professor, IU Kelley School of Business

What’s next

The CLEAR LABELS Act will now proceed through the legislative process, with the Senate committee potentially holding additional hearings or votes on the bill.

The takeaway

This case highlights the importance of supply chain transparency in the pharmaceutical industry, as research has shown that the offshoring of drug manufacturing can lead to quality issues and patient safety concerns. The proposed legislation aims to empower consumers by providing them with more information about the origin and quality of their medications.