Feb. 25, 2026
Highlights:
Years of regulatory uncertainty that strains American capital and prolongs pharmaceutical shortages is not acceptable for patients or the economy. While domestic manufacturing is slowed by complex and time-consuming processes, foreign producers step in to meet U.S. demand and capture the associated economic value. This growing dependence on imported pharmaceutical products presents a serious and unsustainable risk to the resilience of the American healthcare system.
The Food and Drug Administration’s (FDA) new PreCheck pilot program provides predictable and timely oversight that allows for a preliminary cohort of companies to move from manufacturing plans to production with speed and confidence. If this system proves successful and scales across the country, President Trump will have cut red tape and effectively dismantled American over-reliance on foreign pharmaceutical manufacturing.
If we want more medicines made in America, we need to make it faster and more predictable to build U.S. facilities. To this end, the FDA has begun accepting participants for its PreCheck pilot program, a new pathway designed to strengthen the domestic pharmaceutical supply chain by reducing regulatory uncertainty for new U.S. drug manufacturing sites. FDA Commissioner Marty Makary noted:
After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.
PreCheck does not skip standards; it sequences engagement so companies can make expensive construction and equipment decisions with confidence. The program follows a two-stage approach, beginning with early engagement to help ensure a facility is ready before it starts operating. That early alignment then supports a smoother application review, with continued interaction to resolve issues efficiently and keep the process moving.
The United States reliance on offshore production is extensive. More than half of finished pharmaceuticals distributed here are manufactured abroad, and just 11% of API manufacturers serving FDA‑approved products are U.S.-based. That concentration amplifies the risk of shortages when a single foreign site falters. PreCheck aims to reduce risk of bottlenecks in the American pharmaceutical sector and create an efficient pathway to surpass major manufacturing powerhouses like China and India through increased domestic production. Reuters reports:
The FDA PreCheck program … aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary regulatory requirements, in line with President Donald Trump’s executive order in May to shift manufacturing of drugs to the United States.
FDA is explicit that PreCheck streamlines process and communication but preserves substantive review and standards. This is the right balance: a faster, clearer route to compliant capacity while maintaining the safety and quality bar patients expect.
PreCheck is a narrowly tailored, pro‑safety, pro‑growth reform that focuses the agency on when engagement occurs, not whether it occurs. Early technical alignment will help manufacturers build plants that are the appropriate size, lock in equipment orders, and build quality systems that meet expectations the first time.
For more information, read the FDA’s announcement on the program here.