Hearings to examine drug safety, supply chains, and the risk to aging Americans.

Special Committee on Aging

2025-09-17

Source: Congress.gov

Summary

This hearing examines the U.S. pharmaceutical supply chain's critical dependence on foreign-made generic drugs, primarily from China and India, and the resulting risks to public health and national security. Witnesses detail how these foreign-manufactured drugs often lack proper oversight, with studies showing higher rates of adverse events and contamination compared to domestically produced equivalents. The testimony reveals that over 75% of essential drugs rely on overseas suppliers, with China producing 90% of global antibiotics and supplying critical active pharmaceutical ingredients to India. Key concerns include the lack of unannounced FDA inspections, the use of shadow facilities to falsify compliance, and the vulnerability of supply chains to geopolitical disruptions. Experts stress that without reforms—such as mandatory country-of-origin labeling, quality transparency, and increased domestic production—millions of Americans, especially seniors, face real risks of medication shortages and safety failures. The hearing underscores the urgent need for bipartisan action to strengthen the supply chain and ensure safe, reliable access to life-saving medications.

Participants

Transcript

Nearly everyone will be prescribed a medication at some point. Whether it be an antibiotic for an infection or a treatment for a chronic condition, people depend on access to safe and high-quality medications. This is especially true for seniors. In 2021, a federal study found that 88.6% of older Americans surveyed reported having been prescribed at least one medication in the past 12 months. 91% of prescriptions filled are for generic drugs. The problem is the United States relies disproportionately on foreign-made generic drugs from communist China and India. The US currently depends on overseas manufacturers for about 75%. of its essential, essential drug supply. Communist China is not our friend. They are the world's largest producers of active pharmaceutical ingredients, and India relies on Communist China for approximately 80% of the active pharmaceutical ingredients they use. A study from Washington University in St. Louis found that 83% of the top 100 generic drugs consumed by U.S. citizens have no U.S.-based active source, U.S.-based source of active ingredients. Not only is the U.S. overdependent on foreign drugs, but these foreign drugs are often lower quality and more dangerous than drugs manufactured in the United States. Earlier this year, a study showed that serious adverse events like hospitalization and death were 54% more likely for foreign generic drugs compared to American-made drugs. Bad drug quality doesn't just mean that a drug is less effective, it can kill. In 2007, 2008, the medication heparin had contaminated ingredients from communist China, killing nearly 100 people.

Deaths from unsafe medications like these contaminated heparin devastated families. Leroy Hubley lost his wife of 48 years, Bonnie, and his son, Randy, just weeks apart. Bonnie and Randy died due to contaminated heparin that they needed for their diagnosis treatment. They were undergoing due to a genetic kidney disease. People who relied on their medication, trusted that it was safe, died. This was an absolute tragedy and must never happen again. But almost 20 years later, we are still seeing many of the same problems and quality issues that existed back then. There is still no routine testing done by the FDA and no incentive for quality. In 2023, contaminated eye drops from India killed four people and caused adverse events in at least 55 patients. Foreign drug manufacturing plants simply aren't subject to the same level of oversight as manufacturing plants here in the United States. That doesn't make sense to any American. Inspections of the drug manufacturing facilities in the United States are unannounced. In communist China and India, many inspections are pre-announced up to weeks in advance, giving manufacturers time to present false conditions or conceal non-sterile and unsafe manufacturing practices. While quality issues present an immediate threat to the lives of seniors and their loved ones, supply chain vulnerabilities presents an existential threat to the country. I know my remarks paint a very dark picture of the reality we face, but it gets much worse. Think about this. If Communist China or India want to shut down the supply of prescription drugs to the United States, they can do so at any moment. And currently, the United States does not have a backup plan. Let me say that again. If the Communist China or India decide to stop supplying the United States with prescription drugs, we will run out of prescription drugs very quickly, and people will die.

Let that sink in. Millions of Americans will not have lifesaving drugs available to them. Americans will get sick. Americans will die. We've seen China place export restrictions on rare earth elements before over trade negotiations. And there's no reason they can't do that for drugs. Additionally, during the COVID-19 pandemic, we saw India block the export of critical ingredients. Many of the disruptions were prompted by supply chain disruptions from Communist China, the birthplace of the COVID-19 pandemic. We simply cannot rely on other countries, especially those who want to destroy us like Communist China, for something as vital as essential medicines. Yet, despite these dangers, we still depend almost entirely on Communist China and India for generic medications, and their grip on the market continues to grow. As of 2021, Communist China and India accounted for 85% of active drug master file submissions, 85%. Applications submitted to the FDA by companies that want to supply drug ingredients to another company. In 2000, they accounted for just 24%. The Administration for Strategic Preparedness and Response

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