Congress Had a Chance to Make Your Drugs Traceable. They Didn’t Follow Through

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<p>If you want to know where in the world your prescription drug is made, good luck.  Currently, prescription drug labeling requirements are so insufficient that even industry veterans can’t figure out where the medicines they take come from or the names of the companies that made them. </p>
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<p>To increase transparency, Sens. Rick Scott (R-Fla.) and Kirsten Gillibrand (D-N.Y.) introduced the bipartisan Clear Labels Act in the Senate on February 5, 2026. The aim was to provide more information on where drugs — and their all-important active ingredients — are produced. When it was introduced, the bill required that package labels include the FDA’s <a href="https://www.aging.senate.gov/press-releases/chairman-scott-ranking-member-gillibrand-introduce-clear-labels-act-to-protect-american-patients-through-drug-origin-transparency-and-stronger-supply-chain-oversight">unique identification number for each factory involved.</a> This would allow consumers to trace each pill and active ingredient to the exact facility where it was made.  </p>
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<p>Why is this important? Amid growing concerns about generic drug quality, doctors, patients, and consumers want manufacturers to be accountable for their products. If consumers taking a generic drug believe it isn't working as expected or experience adverse effects, the original Clear Labels Act could have let them find out where it came from. Companies would no longer be able to hide from their customers.</p>
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<p>But when the bipartisan Senate Health, Education, Labor, and Pensions (HELP) Committee considered and amended the bill on July 22, 2026, t<a href="https://www.help.senate.gov/hearings/the-following-agenda-to-be-considered-07-22-2026">he unique facility identifier provision was removed</a>, making it much harder to determine where life-saving medicines are made. Under the revised bill, the label would include only the manufacturer's name and place of business. This might sound reasonable, but the information is unhelpful if the “place of business” is a domestic importer, for example, when the medicine or active ingredients were produced in a completely different country. </p>
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<h2 class="wp-block-heading">Drug Transparency Has Been a Problem for Decades</h2>
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<p>This is not a new fight. As early as twenty years ago, Congress tried to pass similar transparency measures. In 2008, industry lobbyists quickly scuttled <a href="https://www.govinfo.gov/app/details/BILLS-110s3633is">a bill requiring country-of-origin labeling</a> on drug packages. An industry insider familiar with the labeling bill told me that generic drug companies felt it wouldn't be good for business if Americans knew their medicines were made in overseas facilities rather than in domestic labs subject to stricter FDA regulation. </p>
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<p>While working on my book <em>China Rx (</em>first published in 2018<em>)</em>, I uncovered an internal FDA memo from 1996 written by a dedicated agency employee to then-FDA Commissioner Dr. David Kessler. “We have no control over bulk drugs that enter the U.S….and these can reach anyone, including the President,” it said. In fact, long before that memo, U.S.-based companies were buying critical inputs for generics from factories in China and elsewhere that were hard to trace. Why were they buying them? Because they were cheap.</p>
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<p>Despite the warnings in that government memo, a former senior FDA official told me Washington acts only when there is “a quantifiable, tangible body count” (<em>China Rx</em>, p. 41). </p>
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<p>Outside of actual “body counts” from faulty or tainted drugs — such as the case in 2008 when contaminated vials of the blood thinner <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa0806450">heparin were associated with hundreds of deaths</a> — the potential harm from problematic manufacturers is real. Studies conducted decades ago were already identifying concerns that remain today with certain generic drugs, including <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC10257977/pdf/nihms-1906165.pdf">anti-rejection medications for heart transplant patients</a>, <a href="https://journals.sagepub.com/doi/10.1177/17562864241300047">treatments for multiple sclerosis</a>, and <a href="https://www.neurology.org/doi/10.1212/wnl.0b013e3181df091b">epilepsy medications</a>,</p>
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<h2 class="wp-block-heading">The FDA Can’t Catch Every Drug Quality Problem</h2>
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<p>The FDA is charged with protecting the public from faulty generics, but that duty has been challenging to carry out for decades. </p>
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<p>In a moment of unusual candor for the agency, then-Commissioner Robert Califf, M.D., <a href="https://www.congress.gov/118/chrg/CHRG-118hhrg55847/CHRG-118hhrg55847.pdf">testified before Congress</a> in 2023 and said the agency is hampered in its ability to conduct inspections of manufacturing plants in Asia. (Approximately <a href="https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025">69% of generic drug products</a> are manufactured outside the United States). In his testimony, Dr. Califf expressed serious concern that some companies are not transparent with the agency, particularly about where active ingredients were produced, and that the agency needs that information to assess pharmaceutical quality. </p>
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<p>As legal and regulatory actions to protect the public remain strained, transparency on generic drug quality is essential. The Department of Defense is conducting a pilot program through the <a href="https://chsr.usuhs.edu/pharmaceutical-supply-chain">Uniformed Services University in Bethesda, Maryland</a>, to assess the security and quality of the U.S. military pharmaceutical supply chain. The initiative includes <a href="https://www.govinfo.gov/content/pkg/CREC-2026-07-21/pdf/CREC-2026-07-21-pt1-PgH4736.pdf">quality testing of generic drugs</a> conducted in partnership with Valisure, an independent laboratory that chemically tests medications for quality, potency, and contaminants.</p>
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<p>As of June 2026, Valisure had tested 25 generics from more than 350 suppliers — including all manufacturers' and repackagers’ products for each generic. Fifteen percent received a “red rating,” indicating concerns about toxins and carcinogens or failure to dissolve properly.</p>
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<h2 class="wp-block-heading">When a Generic Drug Fails, Consumers Have Few Options</h2>
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<p>Meanwhile, if consumers believe their generic drug isn't working as it should, they have woefully few options. If a pharmacy substitutes a product from a different manufacturer, the consumer may find out the hard way that it does not work as well for them. In some cases, this can result in serious adverse health consequences, such as with the medication tacrolimus, which prevents organ rejection. Switching back to the version that worked earlier may not be possible if the pharmacy no longer stocks that product. And buying the brand version of the drug may be prohibitively expensive.</p>
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<p>At a March 2026 hearing on pharmaceutical quality and U.S. dependence on foreign drug manufacturers held by the <a href="https://www.aging.senate.gov/hearings/foreign-dependence-how-china-captured-americas-drug-supply">Senate Committee on Aging</a>, former U.S. Representative Ted Yoho of Florida said companies should be held accountable if they introduce a tainted drug. Another witness, Gordon G. Chang, an author and commentator on U.S.-China relations, suggested using product-liability measures, asking, “…why don't we make drug makers strictly liable for the damages caused by pharmaceuticals that are manufactured abroad and imported into the United States?”</p>
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<p>When I testified at the same hearing, I used the example of product liability laws and vehicle tires. If a tire blows out because of a manufacturing defect, the retailer who sold the tire would face reputational risk and be held accountable, as would the manufacturer.</p>
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<p>Similarly, holding generic manufacturers accountable will send a loud signal that poor-quality generics have no place in the marketplace, wherever in the world they are made. </p>
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