At a time of soaring drug prices and volatile world trade policies, the federal government is looking for ways to bring stability to both costs and supply. The U.S. Food and Drug Administration announced this week that it soon will begin accepting applications for the PreCheck Pilot Program, which is designed to increase the domestic supply chain.
The goal of the program, according to the agency, is to increase regulatory predictability, facilitate the construction of manufacturing sites in the United States and streamline aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application. The FDA will begin accepting applications on February 1, select an initial group of new manufacturing facilities and begin conducting PreCheck activities later this year. Selection criteria include:
- Overall alignment with national priorities, such as products to be manufactured;
- Phase of facility development;
- Timeline to producing pharmaceutical products for the U.S. market; and
- Innovation in facility development.
Stakeholder feedback was positive during the Federal Register comment period, with the industry requesting early engagement during facility development phases. This and other feedback will be incorporated into program design. "FDA will create a more predictable regulatory pathway, accelerate domestic pharmaceutical manufacturing and protect patient safety through the implementation of the PreCheck Program," the agency said in a news release.
This program is part of a broader strategy to reduce drug shortages and safeguard public health by improving supply chain resilience. Health care costs in general – and drug prices in particular – are a top priority for consumers, political leader and government agencies. Health care costs for a typical family of four have increased to $35,119, according to the Milliman Medical Index. Costs for the average person increased by 6.7% to $7,871 in 2025, led by a 9.7% hike in pharmacy expenses and an 8.5% rise in outpatient facility care costs.
A recent KFF Health Tracking Poll found that prescription drug costs remain a problem for many Americans. About one in four adults say they or someone living with them have had problems paying for prescription drugs in the past 12 months. This number rises to 41% among uninsured adults and about one-third among Hispanic and Black adults and those with annual household incomes of less than $40,000.
Charles Wessner, a senior policy advisor for the Renewing American Innovation program at the Center for Strategic and International Studies, encourages a long-term approach to ensuring the reliability of the drug supply chain.
"Despite very real challenges, the United States retains a major lead in the discovery, development and commercialization of life-enhancing pharmaceutical products," he said. "The U.S. pharmaceutical ecosystem is complex, and unvetted policy changes risk being disruptive and counterproductive. What is needed a patient, long-term effort of investment and support for companies and workforce development that could achieve the goal of greater reshoring while providing significant health benefits both for the United States and the rest of the world."
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