	Background

FDA is responsible for overseeing the safety and effectiveness of human  drugs marketed in the United States, whether they are manufactured in  foreign or domestic establishments. See figure 1 for a description of this  process. 2). FDA’s Drug Registration Database Contains Inaccuracies and Planned Changes Will Not Ensure the Availability of Accurate Information on Foreign Establishments

DRLS provides FDA with some information that the agency uses to select  establishments for inspection, but contains inaccuracies and does not  provide a complete count of establishments subject to inspection. FDA  officials told us that the agency does not routinely verify the information  provided by establishments to ensure that it is accurate. To create a list of foreign establishments subject to  inspection, the agency relies on information from databases that were not  designed for that purpose and contain divergent estimates—about 3,000  and 6,760 from DRLS and OASIS, respectively. FDA Inspects Relatively Few Foreign Establishments to Assess the Manufacture of Drugs Currently Marketed in the United States

FDA inspects few foreign establishments, relative to domestic  establishments, each year to assess the manufacture of drugs currently  marketed in the United States. The percentage of such foreign  establishments that have been inspected cannot be calculated with  certainty because FDA does not know how many foreign establishments  manufacture drugs for the U.S. market and are thus actually subject to  inspection. Comparing this average number of inspections with  FDA’s count of 3,249 foreign establishments that it used to prioritize its  fiscal year 2007 surveillance inspections suggests that the agency inspects  about 8 percent of foreign establishments in a given year. At this rate it  would take FDA more than 13 years to inspect this group of  establishments once, assuming that no additional establishments are  subject to inspection. They told us that  the agency inspects these domestic establishments about once every   2.7 years. From  fiscal years 2002 through 2007, the number of foreign establishment  inspections FDA conducted varied from year to year, but increased overall  from 220 in fiscal year 2002 to 332 in fiscal year 2007. While FDA has recently made progress in conducting more foreign  inspections, it still inspects relatively few such establishments. FDA Selects Few Foreign Establishments to Inspect the Manufacturing of Drugs Currently Marketed in the United States, in Contrast to Its Inspections of Domestic Establishments

FDA selected few foreign establishments for inspection in order to  examine the manufacturing of drugs currently marketed in the United  States. FDA’s Identification of Serious Deficiencies Has Led Establishments to Take Corrective Actions, but Subsequent Inspections Were Not Always Timely

Though FDA oversight resulted in foreign establishments taking actions to  address serious deficiencies identified during inspections, FDA’s  subsequent inspections of these establishments were not always timely. Although FDA verified  these corrective actions during subsequent inspections, FDA inspections  to determine establishments’ continued compliance were not always  timely and identified additional deficiencies. Determining the number of inspections during which FDA identified  serious deficiencies is hindered by inconsistencies in databases used by  FDA to track inspections. FDA Issued Warning Letters to Establishments, Most of which Had Previous Deficiencies

FDA issued warning letters to establishments at which it identified serious  deficiencies. 4.) For 3 establishments, FDA had  previously determined the adequacy of their corrective actions by  reviewing information provided by the establishment. Therefore, it is important that FDA inspect  foreign and domestic establishments with similar characteristics at  comparable frequencies. Ensure that information on the classification of inspections with serious  deficiencies is accurate in all FDA databases. To examine the extent to which FDA has accurate data on the number of  foreign manufacturing establishments subject to inspection, we obtained  information from FDA databases on establishments whose drugs have  been imported into the United States. Food and Drug Administration: Improvements Needed in the Foreign  Drug Inspection Program.
Why GAO Did This Study

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees the safety and effectiveness of human drugs marketed in the United States, including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection, (2) the frequency of foreign inspections, and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. GAO analyzed information from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials.

What GAO Found

FDA databases contain inaccurate information on foreign establishments subject to inspection. FDA uses information from a database of establishments registered to market drugs in the United States and a database of establishments that shipped drugs to the United States to compile a list of establishments subject to inspection, but these databases contain divergent estimates--about 3,000 and 6,800, respectively. FDA's registration database contains information about establishments not subject to FDA inspection. Although annual reregistration is required, FDA does not deactivate in its database establishments that do not fulfill this requirement. The agency also does not routinely verify that a registered establishment manufactures a drug for the U.S. market. The accuracy of this information is important in FDA's identification of foreign establishments subject to inspection. FDA inspects relatively few foreign establishments each year to assess the manufacturing of drugs currently marketed in the United States. 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. However, using a list FDA developed to prioritize foreign establishments for inspection in fiscal year 2007, GAO estimated that FDA may inspect about 8 percent of foreign establishments in a given year. At this rate, it would take the agency more than 13 years to inspect these establishments once. In contrast, FDA estimates that it inspects domestic establishments about once every 2.7 years. Unlike domestic establishments, foreign establishments were generally only inspected if they were named in an application for a new drug. While FDA made progress in fiscal year 2007 in conducting more foreign inspections, GAO estimated it still inspected less than 11 percent of such establishments. As FDA plans additional inspections, it is important that it ensure that foreign and domestic establishments with similar characteristics are inspected at a similar frequency. FDA's identification of serious deficiencies has led foreign establishments to take corrective actions, but inspections to determine continued compliance are not always timely. FDA identified deficiencies during most foreign inspections, but determining how the agency classified the results of a specific inspection is hindered by inconsistencies in its databases, particularly on the classification of inspections with serious deficiencies. From fiscal years 2002 through 2007, FDA issued 15 warning letters to foreign establishments at which it identified serious deficiencies. FDA generally determined the adequacy of actions taken in response to these letters by reviewing information provided by the establishments. FDA's subsequent inspections to determine establishments' continued compliance were not always timely. Of establishments named in the 15 warning letters, FDA subsequently inspected 4 establishments 2 to 5 years later, generally because these establishments were named in a new drug application. At 3 of these 4 inspections, FDA verified that corrective actions had been taken but identified additional deficiencies.