WASHINGTON, D.C. — Sen. Jim Banks, R-Ind., Oct. 14 sent a letter to Dr. Martin Makary, commissioner of the Food and Drug Administration, urging the agency to strengthen oversight of the U.S. drug supply amid growing concerns about poor-quality foreign manufacturers — particularly in China and India. The FDA’s inspections of drug manufacturing facilities have not yet returned to pre-pandemic levels.
In part, the letter reads:
“The FDA must do more to protect the U.S. drug supply. Unfortunately, shoddy foreign pharmaceutical plants and unscrupulous domestic producers that import from them are nothing new. The public expects the FDA to protect them from impure drugs by identifying them at the source and blocking them from entering the supply chain. The FDA’s import alerts demonstrate the extent of the problem. Among all facilities that were issued import alerts, 39% were located in China and 13% were located in India, versus the 10% average for other regions. In fiscal year 2024, the FDA only inspected 28% of Chinese facilities and 33% of Indian facilities in the Site Catalog (the list of facilities known to manufacture human pharmaceuticals for the U.S.). Of the facilities that were inspected, Indian manufacturers had the highest rate of serious ‘Current Good Manufacturing Practice’ violations, at 13%.”