Calls for Quota to Protect U.S. Security and Industry
WASHINGTON, D.C. — The Coalition for a Prosperous America (CPA) commends the Trump administration and U.S. Department of Commerce for recognizing our massive reliance on foreign imports of generic pharmaceuticals and pharmaceutical ingredients, particularly from India. This dependence poses a growing threat to U.S. national security, supply chain resilience, and economic competitiveness. This acknowledgment comes in last week’s United States–India Joint Leaders’ Statement. Unlike the US-EU Joint Statement from August 2025, which promised Europe a 15% ad valorem tariff ceiling in the Pharmaceutical Section 232 action, the US-India Statement promised India only that it would receive a “negotiated outcome.” This is compatible with CPA’s recommendation in the Section 232 Pharmaceutical action that the Administration deploy quotas to limit access to the U.S. market.
CPA believes the goal for essential medicines should be domestic self-reliance, not mutually beneficial trade. Allowing imports to displace U.S. pharmaceuticals risks exacerbating the very vulnerabilities our nation confronted during the COVID-19 pandemic. India remains one of the largest global exporters of generic drugs and active pharmaceutical ingredients (APIs), a market share that today accounts for a significant portion of U.S. generics supply.
U.S. companies are rapidly searching for ways to reduce reliance on foreign suppliers like China and India, who are undercutting American producers and dominating the market for nearly 70-80% of our essential medicines. These Indian and Chinese suppliers also operate at a much lower safety level that is not equivalent with U.S. standards. Indian-made generics are found to have a 54% higher rate of severe adverse events compared to U.S.-made drugs.
“This Interim Agreement framework reflects a long overdue acknowledgment that essential medicine supply chains cannot be left to foreign dominance, particularly by India or an adversary like China,” said Jon Toomey, President of CPA. “For decades, U.S. policymakers and industry have outsourced the production of generic drugs and key inputs to a small number of foreign producers. That has cost American jobs, hollowed out domestic manufacturing capacity, and left patients vulnerable to supply disruptions and foreign producers that have repeatedly failed basic safety standards.”
Since April of last year, CPA has backed the Department of Commerce’s initiation of a Section 232 national security investigation into imports of pharmaceuticals and pharmaceutical ingredients, assessing the effects of import reliance on domestic supply, national security, and public health. Under this 232, the administration is exploring whether additional measures – including tariffs, quotas, or other safeguards – are necessary to protect America’s health industrial base.
CPA has called upon the administration to use the full scope of Section 232 authority to implement a tiered quota on imports of generic pharmaceuticals and key pharmaceutical ingredients that will build U.S. capacity in the long-term and secure safe supply standards in the short-term. Such a quota, calibrated to U.S. production capacity and national security needs, would help rebuild domestic manufacturing, provide reliable access to essential medicines from domestic or trusted, high-standard sources, and reduce strategic dependency on risky and adversarial foreign suppliers.
“Protecting Americans’ access to affordable medicines should not come at the cost of surrendering our capacity to produce those medicines domestically and safely,” said Toomey. “Placing a quota on pharmaceutical imports, one that truly rewards and incentivizes U.S. manufacturing, while protecting against foreign overcapacity, will ultimately strengthen supply chain resilience.” Toomey continued, “Generic drugs today are the backbone of affordable healthcare in the United States, but if we allow that to be underwritten almost entirely by a small number of foreign suppliers, we risk shortages, price shocks, and strategic vulnerability in times of global stress.”
CPA continues to urge the administration, the Bureau of Industry and Security at the Department of Commerce, and the Office of the U.S. Trade Representative to move forward with targeted quota proposals as part of the pharmaceutical Section 232 process. Doing so would signal to India – as well as to China and to others – that the United States is serious about protecting domestic industrial capacity, securing critical supply chains, and putting American workers and patients first.
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