Why it Matters

Congress is examining how to strengthen U.S. generic drug manufacturing as the country remains heavily dependent on foreign pharmaceutical ingredients and policymakers consider faster FDA reviews and inspections to encourage more domestic production.

An estimated 70 Percent to 80 Percent of active pharmaceutical ingredients used in U.S. medicines originate abroad, and China and India are described as dominant suppliers. The policy stakes include FDA programs that offer priority review for certain generic drug applications involving domestic manufacturing and a proposal for faster facility inspections before an application is submitted.

The Senate Special Committee on Aging has scheduled “Hearings To Examine Leveling The Playing Field, Focusing On Restoring America's Edge In Generic Drug Manufacturing” for Sept. 23 under Chair Sen. Rick Scott (R-FL) and Ranking Member Sen. Kirsten Gillibrand (D-NY).

Broader Context

IBISWorld reported that the U.S. generic pharmaceutical manufacturing industry's market size declined at a compound annual growth rate of 7.8 Percent between 2021 and 2026. The industry’s U.S. market size was reported at $28.5 billion in 2026, with 461 generic pharmaceutical manufacturing businesses listed that year. Lobbying records show that Hikma Pharmaceuticals USA Inc. addressed health and pharmaceutical policies, domestic pharmaceutical manufacturing supply-chain issues, drug shortages and trade policies affecting domestic generic pharmaceutical manufacturing in filings covering the fourth quarter of 2025 through the second quarter. Legis1 puts Hikma’s reported lobbying expenditures across that period at $130,000, including $40,000 in the fourth quarter of 2025, $30,000 in the first quarter and $60,000 in the second quarter.

The Bottom Line

FDA held a public meeting concerning generic drug policy on Sept. 17. The current GDUFA authorization expires in September 2027. The record also identifies a potential policy path through application prioritization and faster inspections, while the committee’s hearing title centers the question of how to restore U.S. manufacturing capacity.

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