A Congressional committee is demanding the U.S. Food and Drug Administration provide detailed information about pharmaceutical plant inspections in China and India, two countries whose significant production of generic drugs and active pharmaceutical ingredients has caused concern about an overreliance on foreign manufacturers.
Chinese and Indian manufacturers receive the largest number of warning letters about quality control issues from the FDA, including carcinogens in medicines, destroyed or falsified data, and sterility problems in manufacturing. But an ongoing crisis over prescription drug shortages is simultaneously prompting the FDA to make compromises when confronting wayward manufacturers.
In a July 18 letter to the FDA, the House Energy & Commerce Committee noted that some companies have a “demonstrated pattern of repeatedly violating FDA safety regulations.” But due to rising shortages, the agency is allowing temporary imports of otherwise unapproved drugs from China and India, which “makes having effective foreign inspection programs in those countries critical.”