Witnesses at last month’s hearing of the House Energy and Commerce Subcommittee on Oversight and Investigations detailed the FDA’s insufficient policies for assuring the quality of foreign-manufactured drugs and active pharmaceutical ingredients (APIs). According to the GAO, 80% of APIs and 40% of all finished drugs sold in the US are imported. The GAO said that the FDA only inspected 295 of the more than 6,000 foreign manufacturers that export to the US, including only 13 of the 714 Chinese firms. A former FDA official explained that the FDA’s current border inspection policies for drugs are based on the organization’s food inspection policies, which do not cover drugs adequately; furthermore, only 1% of imported drugs are inspected at the border. According to a member of the European API industry, the European drug industry also imports about 80% of its APIs and its regulatory policies regarding imported drugs are as weak as those of the US.

Source: C&EN