The United States is amid a dangerous drug shortage that endangers patients, undermines our health care system and exposes a deep vulnerability to national security. America’s overwhelming reliance on foreign manufacturers for generic drugs is at the center of it.
For decades, countries such as India and China have flooded the U.S. market with low-cost generics, which are backed by heavy government subsidies and lax regulatory oversight. India’s Production Linked Incentives scheme alone has pumped billions of dollars into subsidizing India’s pharmaceutical exports. This uneven playing field has eroded the U.S. industrial base and left us dangerously dependent on opaque, overseas supply chains.
The consequences are not just economic; they’re personal and sometimes fatal.
A groundbreaking new study published in Production and Operations Management reveals that patients taking generic drugs made in India are 54.3% more likely to suffer serious adverse health events than patients taking equivalent drugs made in advanced economies such as the U.S. and Europe. The researchers — hailing from Ohio State University, Indiana University and Brigham Young University — compared drugs using equivalency standards defined by the Food and Drug Administration and controlled for variables such as drug volume and manufacturer size. Their conclusion was clear: Not all generics are created equal, and where a drug is made matters.
This is especially true for mature generic drugs, which have been on the market for years and are most vulnerable to cost-cutting. The study found that operations and supply chain decisions abroad compromise drug quality and patient safety in these cases.
We need to reverse course. That means investing in a stronger, safer and more resilient domestic generic drug manufacturing industry.
The good news is that the capacity and expertise already exist. High-quality manufacturers in the United States and Europe could expand or relocate production to America, especially with the right incentives.
A smart policy like the PILLS Act, introduced by Rep. Claudia Tenney, New York Republican, would offer long-term procurement contracts and prioritize domestic production of essential generics. It’s precisely the market signal needed to attract serious investment and rebuild the industry at home.
President Trump has also rightly identified the generic drug crisis as “not just a public health crisis; it’s a national security crisis.” To address this issue, the president has said he will “phase in tariffs and import restrictions to bring back production of all essential medicines to the United States of America.” Implementing a strategic, sector-based tariff through Section 232 of U.S. trade law, in combination with the PILLS Act, would be a powerful solution to reshore this essential industry.
We should also encourage our allies in the European Union — home to many proven, high-standard pharmaceutical firms — to invest and manufacture in the United States. Doing so increases production capacity and aligns with our shared values of transparency, safety and high-quality production.
This isn’t about shutting out global trade. It’s about ending a dangerous overreliance on suppliers that do not meet consistent safety or quality standards. It’s about building a modern generic drug ecosystem in America that’s secure, diversified and worthy of public trust.
The moment demands leadership from Congress, the administration and the private sector. The tools are on the table: targeted investment, long-term contracts, strong enforcement and carefully considered trade actions. It’s time to step up and lead. America’s patients are depending on it.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
America’s Generic Drug Crisis Demands Investment, Not Dependence
by JON TOOMEY
We need to 'reshore' this essential industry
The United States is amid a dangerous drug shortage that endangers patients, undermines our health care system and exposes a deep vulnerability to national security. America’s overwhelming reliance on foreign manufacturers for generic drugs is at the center of it.
For decades, countries such as India and China have flooded the U.S. market with low-cost generics, which are backed by heavy government subsidies and lax regulatory oversight. India’s Production Linked Incentives scheme alone has pumped billions of dollars into subsidizing India’s pharmaceutical exports. This uneven playing field has eroded the U.S. industrial base and left us dangerously dependent on opaque, overseas supply chains.
The consequences are not just economic; they’re personal and sometimes fatal.
A groundbreaking new study published in Production and Operations Management reveals that patients taking generic drugs made in India are 54.3% more likely to suffer serious adverse health events than patients taking equivalent drugs made in advanced economies such as the U.S. and Europe. The researchers — hailing from Ohio State University, Indiana University and Brigham Young University — compared drugs using equivalency standards defined by the Food and Drug Administration and controlled for variables such as drug volume and manufacturer size. Their conclusion was clear: Not all generics are created equal, and where a drug is made matters.
We need to reverse course. That means investing in a stronger, safer and more resilient domestic generic drug manufacturing industry.
The good news is that the capacity and expertise already exist. High-quality manufacturers in the United States and Europe could expand or relocate production to America, especially with the right incentives.
A smart policy like the PILLS Act, introduced by Rep. Claudia Tenney, New York Republican, would offer long-term procurement contracts and prioritize domestic production of essential generics. It’s precisely the market signal needed to attract serious investment and rebuild the industry at home.
This isn’t about shutting out global trade. It’s about ending a dangerous overreliance on suppliers that do not meet consistent safety or quality standards. It’s about building a modern generic drug ecosystem in America that’s secure, diversified and worthy of public trust.
The moment demands leadership from Congress, the administration and the private sector. The tools are on the table: targeted investment, long-term contracts, strong enforcement and carefully considered trade actions. It’s time to step up and lead. America’s patients are depending on it.
Jon Toomey is President of the Coalition for a Prosperous America. To view this op-ed where it first appeared at Washington Times, click here.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
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