GAO report condemns Food and Drug Administration on foreign inspections

The Food and Drug Administration does not keep accurate records of foreign drug manufacturers and is inspecting those firms at a dismal rate, according to a Government Accountability Office report released Wednesday.

GAO found FDA does not enforce requirements for foreign pharmaceutical businesses to register annually with the agency, so the agency does not know how many firms subject to inspection exist. FDA inspects foreign drugmakers once every 13 years, in contrast to an average rate of 2.7 years for domestic firms, GAO found. GAO and FDA officials alluded to much of this data during House Energy and Commerce Committee hearings on the safety of the drug supply.

GAO also found that FDA issued 15 warning letters to foreign drug establishments citing serious deficiencies between fiscal years 2002 and 2007, and followed up with inspections at four of the plants to ensure compliance as long as five years later. HHS has agreed that FDA needs to increase foreign inspections, but cautioned that is only one component of a comprehensive effort the agency is making to better protect the drug supply.