Research by an Indiana University faculty member 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.
George Ball, an associate professor of operations and decisions technologies and Weimer Faculty Fellow at the IU Kelley School of Business in Bloomington, exposed serious concerns about the quality of generic medications produced abroad in a paper published last year in the journal Production and Operations Management. He was later invited to testify before the U.S. Senate Special Committee on Aging in September related to this paper, as well as to a working paper under review that provides a remedy for this quality problem.
A co-author on that working paper, "Generic Drug Transparency: Testing a Regulatory Policy Proposal" was invited back to testify before the committee on the same topic in January.
Ball's testimony drew upon their research, which found an increase in adverse events resulting from generic drugs made in India compared to equivalently designed generic drugs made in the U.S. His colleague's testimony drew upon the newer paper that provides the transparency solution for this issue of quality.
"The FDA has told the public for decades that consumers can trust a drug if it is FDA-approved," said Ball, who previously served as a principal investigator on a $1.7 million U.S. Food and Drug Administration project to improve the agency's quality management resources when inspecting drug companies' manufacturing operations. "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.
"Most consumers trust their doctors and pharmacists and simply take whatever they are prescribed, but they should be aware that all drugs are not necessarily equivalent."
The committee before which Ball and his co-author testified is chaired by Sen. Rick Scott, R-Fla., and includes Ranking Minority Member Sen. Kirsten Gillibrand, D-N.Y. Scott introduced the newly proposed bipartisan legislation, Senate Bill 3788, dubbed "The CLEAR LABELS Act."
George Ball. Photo courtesy of the IU Kelley School of Business
"Transparency is critical to protecting patient safety, strengthening oversight and reducing America's overreliance on foreign drug production," Scott said in a news release introducing the legislation. "Americans deserve to have confidence that the medicines they take are safe, regulated and clearly labeled."
Ball and his colleague's research 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. The FDA will not release that information through the Freedom of Information Act, but Ball and his colleagues were able to use the Structured Product Labeling dataset to link drugs to the factories where they were produced.
A remedy for the increased offshoring of drug manufacturing - and associated quality risk - that Ball and his co-authors proposed in their upcoming paper is to provide country of origin and a quality rating on the drug's label. This is what the CLEAR LABELS Act would require.
"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," Ball said. "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."
Transparency is the market-driven means to improve product quality and safety, and to move from a cost-only competitive market to a cost- and quality-driven market, he added.
"I sincerely believe that Sens. Scott and Gillibrand were convinced by our testimony and genuinely seek to improve the quality of the drug supply chain," Ball said. "I was happy to see them introduce the CLEAR LABELS Act, and I am grateful for the opportunity to share our research with them and all other members of the Senate Aging Committee."
Before joining academia, Ball spent 11 years in managerial and director roles at two major medical device companies and often was involved with product recall decisions. That professional experience greatly informs his research today, with the goal of improving public health.
Since joining the Indiana University Kelley School of Business faculty in 2015, most of the papers he and his co-authors have published have focused on product quality, recalls, supply chain issues and regulatory policy, particularly for FDA-regulated medical devices and pharmaceuticals.
