The FDA is ramping up oversight of foreign manufacturing sites by expanding its use of unannounced inspections, a move aimed at leveling the playing field between domestic and international drugmakers, according to a May 6 news release from the agency.
Here are five notes:
- FDA Commissioner Martin Makary, MD, said the agency will no longer give advance notice to foreign manufacturers producing essential medicines and medical products.
“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,” he said in the release. “This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.” - The policy builds on the FDA’s Foreign Unannounced Inspection Pilot Program in India and China. The initiative aims to restore comprehensive oversight of foreign drug manufacturing facilities.
- To maintain transparency, the FDA will also revise policies to prohibit investigators from accepting travel accommodations from regulated foreign firms, the release said.
- The FDA conducts approximately 3,000 foreign inspections annually in more than 90 countries. Despite advance notice, the FDA has found serious deficiencies more than twice the rate of domestic facilities, the release said.
- The policy aligns with broader federal efforts to reduce U.S. reliance on foreign drug manufacturing. An executive order President Donald Trump signed May 5 directs the FDA to raise inspection fees on foreign plants and support faster approvals for domestic plants.
