Federal Drug Safety Bill Informed by IU Research on Generic Drug Quality

Proposed legislation would require manufacturers and supply chain details on prescription drug labels

Mar. 31, 2026 at 4:00am

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Research by Indiana University professor George Ball linking overseas generic drugs to higher adverse events has helped inspire proposed federal legislation that would amend the Federal Food, Drug and Cosmetic Act. The CLEAR LABELS Act would require original manufacturer and supply chain information on prescription drug labels to improve transparency and drug quality.

Why it matters

Ball's research exposed serious concerns about the quality of generic medications produced abroad, finding an increase in adverse events resulting from generic drugs made in India compared to equivalently designed generic drugs made in the U.S. Providing country of origin and quality ratings on drug labels is seen as a market-driven solution to improve product safety and move from a cost-only to a cost- and quality-driven pharmaceutical market.

The details

Ball, an associate professor at the IU Kelley School of Business, testified before the U.S. Senate Special Committee on Aging about his research linking overseas generic drugs to higher adverse events. His colleague also testified on a proposed remedy of providing country of origin and quality ratings on drug labels. This testimony informed the new bipartisan CLEAR LABELS Act, introduced by Sens. Rick Scott (R-Fla.) and Kirsten Gillibrand (D-N.Y.), which would require this transparency on prescription drug labels.

  • Ball testified before the Senate Aging Committee in September 2025.
  • Ball's colleague testified before the committee in January 2026.
  • The CLEAR LABELS Act was introduced in the Senate in February 2026.

The players

George Ball

An associate professor of operations and decisions technologies and Weimer Faculty Fellow at the IU Kelley School of Business, whose research on the quality of generic drugs produced abroad informed the proposed federal legislation.

Sen. Rick Scott

A Republican senator from Florida who chairs the U.S. Senate Special Committee on Aging and introduced the CLEAR LABELS Act.

Sen. Kirsten Gillibrand

A Democratic senator from New York who is the Ranking Minority Member of the U.S. Senate Special Committee on Aging and co-sponsor of the CLEAR LABELS Act.

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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

“The FDA has told the public for decades that consumers can trust a drug if it is FDA-approved. While that may be true in aggregate, there are plenty of specific cases where a generic drug is produced at uber-low costs in distant locations that the FDA has difficulty accessing.”

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

What’s next

The CLEAR LABELS Act will now move through the Senate committee process and legislative debate, with a goal of passing both chambers of Congress and being signed into law by the president.

The takeaway

This legislation, informed by IU research, aims to improve transparency in the pharmaceutical supply chain and empower consumers to make more informed decisions about the safety and quality of the medications they take, moving the industry away from a cost-driven model toward one that also prioritizes product quality.