Policymakers have been aware of US vulnerability to Chinese supply chain dominance for decades and have considered the possibility that Beijing could strengthen its control by restricting exports to the United States. Last summer, Chinese President Xi Jinping did the same. Relying on an adversary’s good graces in national health and security leads to disaster. But critical minerals are just one weakness. Washington also relies on Beijing for the country’s pharmaceutical products. It should be unbearable.
In 2000, America imported approximately 100,000 tons of pharmaceutical products. By 2024, that figure had risen above 800,000 tons. Last year, the United States imported roughly 90% of the raw materials for prescription drugs. About half of these drugs come from India, but India sources 70% to 80% of its active pharmaceutical ingredients (APIs) from China.
America’s medical dependence on the Chinese Communist Party (CCP) does not end there. Chinese companies are now beginning to surpass American competitors in drug discovery, and not just in drug manufacturing. Consider this warning from the National Security Commission on Emerging Biotechnology: “In just three years, China’s biopharmaceutical industry has risen from virtual irrelevance to dominance.”
What does that mean practically? According to the commission’s findings, “This overall innovation trend will accelerate, with Chinese medicines expected to account for 35% of new drug approvals by 2040.”
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The United States has become dangerously dependent on China for prescription drugs. (iStock)
Americans are witnessing the outsourcing of our drug supply chains to a foreign adversary that has already exploited its control over crucial minerals. The CCP has threatened to do the same with drugs. During the early days of the COVID-19 pandemic in March 2020, China’s state media service Xinhua published commentary threatening to impose export controls on pharmaceutical products to the United States, plunging America into a “sea of coronavirus.”
America’s healthcare infrastructure depends on a country with a history of weak intellectual property enforcement, state-sponsored chemical exports, and hostile trade behavior. The next pandemic or health crisis could be purposefully weaponized through our own medicine cabinets. The threat is worrying, but the risks are not hypothetical. Beijing’s lack of quality health standards has caused significant harm to Americans over the past thirty years.
In 1996, an internal Food and Drug Administration (FDA) memo issued a stark warning: “We literally have no control over bulk pharmaceuticals entering the US.” The following year, Congress took steps to address this threat by requiring foreign pharmaceutical companies to register with the FDA. However, ten years later the government had not enforced this requirement. The results were deadly. In 2008, hundreds of Americans were injured or killed by contaminated heparin, a blood thinner used in dialysis, surgery and care to prevent blood clots.
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Once again, Congress took action and provided FDA authorities with funding for foreign inspections by passing the Food and Drug Administration Safety and Innovation Act of 2012. What has often emerged, however, is a cat-and-mouse game with Chinese manufacturers delaying inspections and hiding potentially affected products, while Beijing delays granting visas to FDA inspectors.
This history underscores the twin crises of China’s dominance over American pharmaceuticals. On the one hand, poor regulation, cost-cutting measures, and avoidant behavior have endangered, harmed, and in some cases killed Americans who rely on life-saving medications.
On the other hand, the United States has no alternative suppliers to turn to. At this point, we are stuck in the unacceptable position of hoping the CCP will not exploit this vulnerability as it has done with critical minerals. In their 2021 book “China Rx,” authors Rosemary Gibson and Janardan Prasad Singh underscore this threat: “A poorly made drug can be the difference between life and death for those who use it. With medicine there is no room for error. And it better be available when we need it.” For these reasons, they warn that “the global dependence on a single country for life-saving medicines is breathtaking.”
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Breathtaking, yet these concerns persist. In January, Illinois Democratic Rep. Raja Krishnamoorthi sent letters to multiple Chinese companies over concerns about mislabeled and counterfeit GLP-1 drugs. Shortly thereafter, Republican Senator Rick Scott of Florida introduced bipartisan legislation with New York Democratic Senator Kirsten Gillibrand to establish country of origin labeling requirements for drugs and APIs. Awareness is growing, but Americans need their governing institutions to take action.
Most urgently, President Donald Trump should revise an executive order from his first administration that required the U.S. government to prioritize domestic pharmaceutical manufacturers in government procurement, with particular attention to antibiotics. Second, the government should fully enforce the Drug Supply Chain Security Act and ensure real-time digital tracking of pharmaceutical products from the point of production to the point of sale.
What has often occurred, however, is a cat-and-mouse game in which Chinese manufacturers delay inspections and hide potentially affected products, while Beijing delays granting visas to FDA inspectors.
In the meantime, Congress should pass legislation requiring all APIs used in sterile injectable medications to be sourced only from FDA-registered suppliers, with mandatory independent testing prior to compounding. Congress should also require the FDA and DHS to permanently blacklist foreign entities caught shipping misbranded APIs and punish U.S. companies that continue to buy from these sources.
This must be accompanied by diplomatic pressure on the Chinese government to take tough action against illegal exporters of active pharmaceutical ingredients. It should also include diplomatic initiatives with allies and partners to help track Chinese composite producer exports to the US through other markets.
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Washington also needs a strategy for foreign dependence on pharmaceuticals, aimed at reducing API production and boosting domestic production. This could include tax credits, direct federal contracts, and accelerated regulations for companies willing to invest in U.S. API factories. This would not necessarily aim at full autonomy, but rather at greater capacity for domestic production, making us less susceptible to shocks from foreign sources.
Congress should also increase criminal penalties for domestic distributors and compounding companies that knowingly use noncompliant APIs, especially in products labeled for injection. Sanctions should be imposed on PRC entities involved in the export of counterfeit APIs. Patient safety should be treated not just as a medical issue, but as a national defense priority.
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Finally, and perhaps most obviously, Congress should enact a blanket ban on composite imports from China within a reasonable timeframe. This should be accompanied by increased resources for customs and border protection to adequately inspect de minimis imports from China.
The pharmaceutical market should not be an afterthought to regulation. The integrity of our drug supply is vulnerable to the whims of strategic rivals. Washington must act now to ensure the integrity and independence of our health care system. Our health and sovereignty depend on it.
Michael Sobolik is a senior fellow at the Hudson Institute, specializing in U.S.-China relations.
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