Washington, Jan 30 (IANS) US lawmakers renewed a push to require country-of-origin labeling on prescription drugs, citing temporary restrictions on pharmaceutical exports during the Covid-19 pandemic by India as evidence that America’s drug supply remains vulnerable to foreign disruptions.
The call came during a hearing of the Senate Special Committee on Aging titled “Truth in Labeling: Americans Deserve to Know Where Their Drugs Come From.”
Committee Chairman Rick Scott announced his CLEAR LABELS Act, legislation that would require prescription drugs sold in the United States to disclose where they and their key ingredients are made.
“What we uncovered during this investigation will shock you,” Scott said.
He said 91 per cent of prescriptions in the United States are for generic drugs. Of those, “almost 94 per cent use APIs produced and processed overseas and factories predominantly in Communist China and India.”
Scott said the lack of transparency leaves patients, doctors, and pharmacists without basic information about the medicines they use. He argued that overseas manufacturing also complicates federal oversight.
When US regulators inspect foreign drug plants, Scott said, they often give advance notice. That allows facilities time to prepare before inspectors arrive. “That’s crazy,” he said, citing reports of unsanitary conditions found even after warnings.
Scott framed the issue as both a health and security concern.
“We face not just a serious public health risk, but a massive national security risk as well,” he said. If foreign suppliers cut off exports, he warned, the United States has “absolutely no plan” to ensure access to life-saving medicines.
He pointed to recent history. “During the Covid pandemic, India blocked the export of critical pharmaceutical ingredients,” Scott said. “So it can happen again.”
Sen. Ashley Moody, who presided over part of the hearing, said consumers have little ability to determine where their medicines come from. She said FDA import alerts have cited problems at foreign facilities, including “carcinogenic impurities, falsified batch records and non-sterile conditions.”
She said seniors are particularly affected because they rely heavily on generic medicines and often have no alternatives.
Witnesses broadly supported greater transparency but warned that labeling alone would not fix deeper problems in the generic drug market.
John Gray, a professor at Ohio State University, said he “strongly supports giving consumers, doctors, pharmacists, and other stakeholders access to basic drug information, including country of origin and some valid assessment of drug quality risk.”
He said the long-standing assumption that all generic drugs are interchangeable “is no longer a defensible assumption,” especially as manufacturing has shifted overseas and inspections are often announced in advance.
Gray recommended placing QR codes on drug packaging. The codes would link to searchable information showing where finished drugs and active ingredients are made. He said quality data should also be made public so manufacturers can compete on more than price.
Michael Ganio of the American Society of Health-System Pharmacists said, “Every American has a right to know where their prescription drugs are manufactured.” He noted that country-of-origin information is currently voluntary.
Ganio said greater transparency could help counter what he described as a “race to the bottom” in generic drug pricing. He urged Congress to also strengthen incentives for domestic manufacturing and oversight.
He said research showed patients and pharmacy purchasers prefer drugs made in the United States or Canada over those from India or China when origin information is disclosed. But he cautioned that “country of origin alone is not a reliable proxy for drug product quality.”
Stephen W. Schondelmeyer, a professor at the University of Minnesota, described India as a critical but complex part of the supply chain.
“India is our major supplier of generic pharmaceuticals,” he said. “There are good quality products that come out of India, not all of them, but some of them.”
He said uneven regulation and limited public visibility into manufacturing locations make it difficult to assess quality and supply risks. He called it “unconscionable” that the United States requires origin labels for food and clothing but not for “the critical drugs that save people’s lives.”
Schondelmeyer pointed to New Zealand’s public drug database as a model for transparency.
Steven Colville of the Duke-Margolis Institute for Health Policy said the drug supply chain faces overlapping challenges. These include chronic shortages, quality concerns, geopolitical risks and efforts to expand domestic manufacturing.
Colville supported better information for consumers but said “labeling reforms alone are likely to have a limited impact.” He noted that patients often have little control over which generic drugs hospitals and pharmacies stock.
The committee said the hearing record will remain open until next week as lawmakers review draft legislation.
US officials have warned for years that dependence on overseas manufacturing leaves the health system exposed to shortages and quality lapses. The Covid-19 pandemic, when several countries restricted exports of medical goods and drug ingredients, intensified bipartisan scrutiny.
–IANS
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