The FDA will be reviewing the effectiveness of its FDA ImportShield Program (FISP)—an initiative that was unveiled in August 2025—which is intended to streamline how the FDA reviews imported products.¹

Since that time, FISP has reportedly boosted processing speed by 66% and monthly volume capacity by 33%. Staff hours have also decreased by 20%, with monthly time savings of 3,388 hours.

"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," noted FDA Commissioner Marty Makary, MD, MPH, in a press release.¹

What operational changes power the FDA ImportShield Program?

Previously known as the Nationalized Entry Review Program, FISP modernizes the agency’s import review process by consolidating five regional teams into a single, centralized procedure. This unified approach provides consistent oversight across all US ports of entry while also leveraging round-the-clock time-zone coverage and specialized commodity expertise under one management framework. As a result, the program bolsters accountability, consistency, and efficiency, when it comes to import decision-making.

How does ImportShield enable real-time risk mitigation?

This centralized model even allows for real-time risk mitigation via nationwide alerts. During situations when the FDA identifies high-risk products—including counterfeit drugs—at one port, alerts are quickly shared across all ports to prevent similar products from entering the supply chain. The approach not only strengthens uniform enforcement of FDA regulations, but closes any gaps that bad actors might be able to exploit between regional teams.

“The FDA's import review workload has grown substantially, with admissibility decisions increasing from 58 million lines in 2024 to 75 million lines in 2025, ”Elizabeth Miller, PharmD, FDA’s associate commissioner for inspections and investigations. “The FDA ImportShield Program helps the agency tackle this volume increase more efficiently.”

Aside from FISP, the agency is looking to undergo a full tech modernization process, headlined by an advanced review platform system with capabilities to incorporate a variety of tools and databases, which maintaining current Customs and Border Protection system connectivity.

The FDA has also had its hands full with staying on top of the Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the review and approval of novel products that are essentially to tackling national priorities, such as increasing accessibility and affordability.

How do National Priority Vouchers Fit into the FDA’s broader strategy?

In that vein, the agency recently awarded two National Priority Vouchers to Merck² for two potential blockbusters: enlicitide decanoate, an oral cholesterol-lowering pill, and sacituzumab tirumotecan, a targeted cancer therapy. Enlicitide decanoate is an oral PCSK9 inhibitor that has proven to significantly reduce LDL-C in hypercholesterolemia and HeFH patients, while sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, improves progression-free and overall survival in EGFR-mutated NSCLC patients resistant to EGFR-TKI therapy.

“High healthcare costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” added Makary in a separate news release.² “We’re pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of health care in America.”

References

1. FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at US Ports of Entry. US Food & Drug Administration. January 21, 2026. Accessed January 22, 2026. https://www.fda.gov/news-events/press-announcements/fda-importshield-program-delivers-impressive-results-strengthening-fda-oversight-us-ports-entry

2. Halpern L. FDA Grants National Priority Vouchers to Enlicitide Decanoate, Sacituzumab Tirumotecan. Pharmacy Times. January 7, 2026. Accessed January 22, 2026. https://www.pharmacytimes.com/view/fda-grants-national-priority-vouchers-to-enlicitide-decanoate-sacituzumab-tirumotecan