GAO Recommends Ways to Improve FDA Foreign Inspections

Washington, DC (Oct. 30)-The US Government Accountability Office (GAO) released a report last week that examines and provides recommendations for the US Food and Drug Administration’s foreign inspection process, including the agency’s data management, inspection frequency, and oversight of problems identified during inspections. According to the report, FDA’s databases contain “inaccurate information on foreign establishments subject to inspection.” Specifically, the agency’s list of establishments registered to market drugs in the US totals around 3000 but its list of establishments that shipped drugs to the US totals closer to 6,800, states GAO.

“The accuracy of this information is important in FDA's identification of foreign establishments subject to inspection,” says the report. “FDA inspected 1,479 foreign drug manufacturing establishments from fiscal years 2002 through 2007. Because FDA does not know the number of establishments subject to inspection, the percentage of those inspected cannot be calculated with certainty.”

GAO reviewed another list that FDA used to prioritize foreign inspections in FY 2007 to gain a better sense of how many inspections FDA is carrying out. With that list, GAO estimated that FDA inspects about 8% of foreign establishments in a given year. “At this rate, it would take the agency more than 13 years to inspect these establishments once,” says the report. Compare this with FDA’s domestic inspection frequency of at least one inspection every 2.7 years.

Additional inconsistencies in the agency’s databases are tied to how FDA classifies its inspection results. From FY 2002 to FY 2007, FDA issued 15 warning letters to foreign establishments at which it identified “serious deficiencies,” according to the GAO report. They agency’s subsequent inspections of those 15 establishments only totaled 4, and that was 2 to 5 years later. And of those 4 inspections, FDA verified that corrective actions had been taken but that additional deficiencies were present.

Considering the industry’s current environment, with reports of contamination largely based in manufacturing establishments outside the US, foreign inspections that are efficient and frequent are more critical than ever. In this regard, GAO made the following recommendations for FDA in its report:

• The FDA Commissioner should enforce the requirement that establishments manufacturing drugs for the US market update their registration annually.

• The FDA Commissioner should establish mechanisms for verifying information provided by the establishment at the time of registration.

• The FDA Commissioner should ensure that information on the classification of inspections with serious deficiencies is accurate in all FDA databases.

• The FDA Commissioner should conduct more inspections to ensure that foreign establishments manufacturing drugs currently marketed in the US are inspected at a frequency comparable to domestic establishments with similar characteristics.

• The FDA Commissioner should conduct timely inspections of foreign establishments that have received warning letters to determine continued compliance.

FDA is expected to comment on GAO’s recommendations, at which time GAO will follow-up its report with updated information.

Read the full report.

See a related article, GAO Criticizes FDA’s Foreign-Drug Inspection Process