New effort to bring drug production back to the US gains steam

By HPN Staff

The Trump Administration is moving to speed generic drug approvals and bring more drug manufacturing back to U.S. soil — an effort to cut red tape, lower prices and reduce reliance on China and India.

This move comes just as the administration announced progress in bringing “Most-Favored-Nation Pricing” to Americans to lower prescription drug prices. The federal government has reached agreements with pharmaceutical manufacturers Eli Lilly and Novo Nordisk to reduce the price Americans pay for drugs that treat obesity, migraines and diabetes.

This is the first time the federal government has negotiated drug prices rather than mandating them.

In a separate action, the FDA is targeting two areas in particular: encouraging domestic production and making complex biologic drugs more competitive. A pilot program accelerates approvals for generic drugs manufactured and tested entirely in the U.S., rewarding companies that invest in American facilities and strengthening the nation’s supply chain. 

Why it matters

U.S. drug production is heavily dependent on foreign suppliers, leaving the supply chain vulnerable and costs high. Only about 9% of active pharmaceutical ingredient manufacturers are based domestically, compared with 22% in China and 44% in India.

“Over-reliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production," said George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research.

The FDA’s domestic pilot program is designed to reverse that imbalance by prioritizing drugs made entirely in the U.S. 

The big picture

In recent weeks, lawmakers have highlighted the risks of America’s reliance on foreign-made drugs, particularly for seniors and national security. A bipartisan Senate Committee on Aging report found that nearly 90% of older adults take at least one prescription medication, yet the U.S. relies almost entirely on China and India for generics.

The Senate findings, combined with FDA initiatives to accelerate domestic generics and streamline biosimilar approvals, signal a broader effort to reclaim control of the U.S. drug supply. Lawmakers frame the issue as both a public-health and national-security priority, while the Trump Administration emphasizes an “America First” approach: deregulation, domestic production, and market-based solutions to reduce costs.