Dangerous Overreliance on Foreign Generic Drugs Poses Clear Threat to U.S. National Security
WASHINGTON — The Coalition for a Prosperous America (CPA) today publicly released comments submitted to the Department of Commerce for its Section 232 National Security Investigation of Pharmaceutical Imports. As the leading organization advocating for reshoring the generic drug industry, CPA’s submission documents how extreme overreliance on foreign pharmaceutical supplies—especially active pharmaceutical ingredients (APIs) and critical injectable drugs from China and India—poses an urgent threat to U.S. national security and patient safety.
Last year, CPA documented how the drug shortage crisis is the result of decades of offshoring our nation’s drug manufacturing capacity, massive failures by the U.S. Food and Drug Administration (FDA) to properly regulate and oversee foreign drug manufacturers, and a massive system of subsidies used by foreign governments to shift generic drug production away from the United States.
The U.S. Department of Defense (DoD) and healthcare system depend on 60 core medicines, many of which rely heavily or exclusively on APIs sourced from China or India. Roughly 20% of these critical drugs have APIs available exclusively from China, creating dangerous single points of failure. Any geopolitical tension, export restriction, or factory disruption in these countries could rapidly cripple America’s supply of essential medications. In 2024, the United States imported over 828 thousand metric tons of pharmaceuticals, representing more than seven times the import volume from 2000, and resulting in a massive $118.3 billion pharmaceutical trade deficit.
"Unlike other industry associations that are conflicted due to their members manufacturing abroad, CPA is proud to be the leading voice addressing this critical national security threat,” said Jon Toomey, President of CPA. "America’s dependence on foreign-made pharmaceuticals directly contributes to the persistent drug-shortage crisis. From antibiotics and blood-pressure medications to essential cancer treatments, the overwhelming majority of generic drugs consumed in the U.S. are manufactured overseas — primarily in China and India. This reliance jeopardizes patient safety, undermines our health security, and weakens the broader U.S. economy."
Quality and Safety Concerns from Low-Quality Imports
CPA’s submission highlights severe quality and safety risks from imported generic drugs, particularly from India and China. A recent medical study demonstrated that patients taking generic drugs produced in India were 54% more likely to experience serious adverse events than those taking equivalent U.S.-manufactured generics. Further, FDA investigations uncovered criminal violations of Good Manufacturing Practices at Indian pharmaceutical plants, including falsified safety data and dangerous contamination issues. Similarly, China has a troubling history of safety scandals, notably the deadly 2008 heparin contamination that killed dozens of Americans.
The FDA has documented criminal violations of Good Manufacturing Practice (CGMP) regulations for pharmaceuticals in India, including falsifying safety data and test results. These quality breaches are beyond just being a potential risk: one FDA investigation linked poor practices at Indian facilities to at least eight patient deaths in the U.S. and an outsized share of drug recalls. Similarly, China has a history of safety scandals (for example, the 2008 heparin contamination from China that killed dozens of Americans. Relying on foreign suppliers with spotty safety records heightens the risk that U.S. patients could use ineffective or dangerous medications and cedes extensive U.S. regulatory oversight. This is a security issue as much as a public health issue.
CPA’s comments advocate for comprehensive and strategic Section 232 tariffs and quotas to protect and revive domestic pharmaceutical production. They recommend targeted actions to reduce import dependency, particularly from adversarial nations, and incentives to expand domestic manufacturing. Specifically, CPA calls for gradual and strategic implementation of import quotas to incentivize U.S.-based pharmaceutical manufacturing, supported by federal policies such as tax credits, advanced purchase agreements, and strategic stockpiling of critical pharmaceutical ingredients.
The quotas should be carefully structured to prevent immediate shortages by prioritizing “Ally-Shoring”—diversifying short-term pharmaceutical supply towards trusted nations with compatible regulatory standards, such as European manufacturers that have a documented history of complying with CGMP. This approach reduces supply risks and reliance on single countries as the U.S. rebuilds its own domestic production.
"Tariffs and quotas are crucial policy tools to incentivize domestic pharmaceutical manufacturing and reduce America’s dependence on unreliable and unsafe imports," added Toomey. "America’s hospitals, consumers, and military deserve secure and safe supplies of medicines. Achieving this requires a clear national strategy to decouple critical pharmaceutical supply chains from China and India and reestablish America’s pharmaceutical manufacturing leadership."
Key Recommendations from CPA’s Comments:
- Implement Section 232 tariffs and quotas on pharmaceutical imports, targeting APIs and finished drugs to ensure national security and health sovereignty.
- Establish strategic stockpiles of critical APIs and drugs to safeguard against short-term disruptions.
- Utilize federal procurement policies (DoD, VA, HHS) to create guaranteed demand for American-made pharmaceuticals.
- Incentivize domestic pharmaceutical production through advanced manufacturing tax credits, grants, and public-private partnerships modeled after successful federal initiatives like the CHIPS Act.
CPA urges the Department of Commerce to conclude this Section 232 investigation by recommending strong measures to rebuild America’s pharmaceutical manufacturing capacity and end the dangerous overreliance on foreign sources that threaten our health security and national sovereignty.
Read CPA’s full submission here.
The national security and public health implications require a priority on stable and safe pharmaceutical supply. A smart policy like the PILLS Act, introduced by Rep. Claudia Tenney (R-NY), would prioritize domestic production of essential generics by incentivizing the strategic reshoring of US production of generic medicines, to cover all materials, testing, and packaging involved at every step of the manufacturing process. This includes upstream inputs such as API, and downstream materials and services such as packaging and quality testing.
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