02:04 PM EDT, 05/06/2025 (MT Newswires) -- The US Food and Drug Administration said Tuesday it plans to expand its use of surprise inspections at foreign facilities that make food, essential medicines, and other medical products for US consumers.

Building on a pilot program conducted in India and China, the move aims to ensure foreign manufacturers face the same level of regulatory scrutiny as domestic ones, the regulator said.

The FDA said it also plans to review and improve its policies for foreign inspections "to ensure that the FDA is the gold standard for regulatory oversight." That includes clarifying guidelines prohibiting FDA investigators from accepting travel accommodations from regulated companies.

Each year, the FDA conducts about 12,000 inspections in the US and 3,000 overseas across more than 90 countries. While US companies often face unannounced inspections, foreign manufacturers have typically been given advance notice, the regulator said.

"For too long, foreign companies have enjoyed a double standard-given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today," FDA Commissioner Martin A. Makary said.

Shares of Merck ( MRK ) were down nearly 5% and Pfizer ( PFE ) declined 3.2% in recent trading.

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