The current administration continues efforts to boost domestic manufacturing.

One of President Trump’s stated goals across all industry has been a desire to reduce the United State’s dependence on imported goods. While he has targeted a wide swath of industries, he has specifically targeted the pharmaceutical industry.

This is most likely due to this particular issue playing a key role in another of the President’s initiatives, reducing the cost of pharmaceuticals in the United States.

On February 1, FDA announced a new pilot program designed to promote the construction of domestic manufacturing sites, along with increasing regulatory predictability and and streamlining manufacturing facility assessments.¹

What criteria will FDA use when admitting sites into the program?

FDA PreCheck will begin in 2026 and include a group of domestic facilities that the agency says are aligned with national priorities. The criteria used to decide this will be:

• Products to be manufactured
• Phase of facility development
• Timeline to producing products to US market
• Innovation in facility development

Also, any facility developing critical medications for the US market will be considered for the initial group.

In a statement FDA Commissioner Marty Makary, MD, MPH, said, “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."

This is just the latest effort by FDA to promote domestic manufacturing and reduce dependence on imports.

In late January, the agency announced the results of the ImportShield Program, which aims to bring consistent oversight to the import review process across the entire country.² In order to achieve this, the existing five regional teams were restructured into just one centralized team.

According to FDA, this resulted in:

• An increase to processing speed by 66%
• An increase to monthly volume capacity by 33%
• A reduction in staff hours by 20%

In a press release, Makary said, “Whether it's detecting counterfeit medications or identifying contaminated food products, the FDA ImportShield Program and other modernization efforts add a powerful new layer of protection for American families."

Meanwhile, major pharmaceutical companies have been announcing major manufacturing projects within the United States.

The latest example of this is Eli Lilly, who just announced plans to invest $3.5 billion in a manufacturing facility in Lehigh Valley, Pennsylvania.³ The site will focus on injectal medicine and device manufacturing. The site should be operational by 2031.

In a press release, Lilly chair and CEO David A. Ricks said, “"Our mission starts with patients and delivering the medicines they need. To meet increasing demand, we're expanding our U.S. manufacturing network, with Lehigh Valley adding capacity for next‑generation weight-loss medicines. We're creating high‑quality jobs and collaborating across the region—with suppliers, educators, and workforce‑development partners—to make critical medicines in the U.S. That's our commitment—to patients, to our new Pennsylvania home and to our country."

In the same press release, Pennsylvania Governor Josh Shapiro said, “"When we announced our Economic Development Strategy here in the Lehigh Valley two years ago, we set out to win historic, life-changing deals like the one we're announcing with Lilly today. Before I took office, Pennsylvania wasn't even in the conversation for major investments like this, but thanks to our work to cut red tape, invest in site development, and expand our workforce, our Commonwealth is now competing—and winning—on a national scale. Lilly's commitment to the Lehigh Valley and to Pennsylvania will bring billions of dollars of investment and hundreds of good-paying jobs, solidifying our position as a leader in the growing life sciences industry."

Sources

1. FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing. FDA. February 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing
2. FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry. FDA. January 21, 2026. https://www.fda.gov/news-events/press-announcements/fda-importshield-program-delivers-impressive-results-strengthening-fda-oversight-us-ports-entry
3. Lilly selects Pennsylvania as home for its newest injectable medicine and device manufacturing facility. Eli Lilly. January 30, 2026. https://investor.lilly.com/news-releases/news-release-details/lilly-selects-pennsylvania-home-its-newest-injectable-medicine