	Background

FDA is responsible for overseeing the safety and effectiveness of human  drugs that are marketed in the United States, whether they are  manufactured in foreign or domestic establishments. Foreign  establishments that market their drugs in the United States must register  with FDA. Through this process, CDER annually prepares a  prioritized list of domestic establishments and a separate, prioritized list of  foreign establishments. FDA relies on multiple databases to manage the foreign drug inspection  program. FDA Lacks Accurate Information to Effectively Manage the Foreign Drug Inspection Program

FDA does not know how many foreign establishments are subject to  inspection; including the number of establishments that are registered and  whose products are currently imported into the United States and  establishments that are not required to register but whose products are  ultimately used in drugs that are marketed here. Instead of maintaining a  list of such establishments, FDA relies on information from several  databases that were not designed for this purpose. According to OASIS, 6,760 foreign establishments  manufactured drugs that were imported into the United States in fiscal  year 2007. Because comparisons of the data and error  identification are done manually, the databases are not conducive to  routine data analysis. FDA officials told us that they have not generated an  accurate count of the establishments whose drugs are imported into the  United States. In addition, although  FDA has implemented a risk-based process in selecting foreign  establishments for GMP surveillance inspections, relatively few such  inspections are conducted. Comparing this average number of inspections with  FDA’s count of 3,249 foreign establishments it used to plan its fiscal year  2007 prioritized GMP surveillance inspections suggests that the agency  inspects about 7 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. The Need to Conduct Preapproval Inspections Associated with NDAs and ANDAs Drives FDA’s Selection of Foreign Establishments

While enforcing GMP compliance through surveillance inspections is  FDA’s most comprehensive program for monitoring the quality of  marketed drugs, FDA’s inspections of most foreign establishments occur  as part of the agency’s review of an NDA or ANDA. In fiscal year 2008, CDER submitted a list of 110 foreign establishments to  ORA, with a negotiated target of at least 50 inspections. To help account for the differences in information available to FDA  between foreign establishments that have and have not been inspected,  the agency categorizes establishments into one of three groups for the  purposes of examining risk scores: (1) those that have received a GMP  surveillance inspection since fiscal year 2000; (2) those that have not  received a GMP surveillance inspection since fiscal year 2000, but have  received another type of inspection in that time (for example, a  preapproval inspection or a veterinary drugs inspection); and (3) those  that may never have received an inspection. These counts do not represent the number of  individuals that actually conduct foreign inspections in a given year. FDA relies on investigators and laboratory analysts to volunteer to  conduct foreign inspections. In addition, FDA  does not have the same flexibility to extend the length of foreign  inspection trips if problems are encountered as it does with domestic  inspections because of the need to maintain the inspection schedule,  which FDA officials told us typically involves inspections of multiple  establishments in the same country. FDA officials also told us that language barriers can make foreign  inspections more difficult to conduct than domestic inspections. The  agency does not generally provide translators in foreign countries, nor  does it require that foreign establishments provide independent  interpreters. Instead, they may have to rely on an English-speaking  representative of the foreign establishment being inspected, who may not  be a translator by training, rather than rely on an independent translator. More than nine years ago we reported that FDA needed to make  improvements in its foreign drug inspection program. We also recognize that FDA has taken  steps to improve its management of the foreign drug inspection program  by enhancing the risk-based process it uses to select establishments for  GMP surveillance inspections.
Why GAO Did This Study

Many drugs marketed in the United States are manufactured in foreign countries and the value of such products entering the country is increasing. The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the United States, whether they are manufactured in foreign or domestic establishments. Foreign establishments that market their drugs in the United States must register with FDA and FDA inspects foreign establishments to ensure that they meet the same standards that are required of domestic ones. GAO reported 9 years ago that FDA needed to improve its foreign drug inspection program (GAO/HEHS-98-21). Questions remain as to whether FDA has improved its management of the foreign drug inspection program. This statement discusses preliminary information on (1) the extent to which FDA has accurate data to manage the foreign drug inspection program, (2) the frequency of foreign inspections and factors influencing the selection of establishments to inspect, and (3) issues unique to conducting foreign inspections. To address these issues GAO interviewed FDA officials; reviewed pertinent statutes, regulations, and guidance; and analyzed information from FDA databases. Because of the preliminary nature of our work, we are not making recommendations at this time.

What GAO Found

FDA's effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its databases. FDA does not know how many foreign establishments are subject to inspection. Instead, FDA relies on databases that were not designed for this purpose. Further, these databases contain inaccuracies that FDA cannot easily reconcile. One database indicates there were about 3,000 foreign establishments registered to market drugs in the United States in fiscal year 2007, while another indicates that about 6,800 foreign establishments actually imported drugs in that year. FDA recognizes these flaws. Further, because the databases cannot exchange information, any comparisons of the data are performed manually, on a case-by-case basis. FDA officials told GAO that they have not generated an accurate count of foreign establishments whose drugs are imported into the United States. FDA inspects relatively few foreign establishments. Data from FDA suggest that the agency may inspect about 7 percent of foreign establishments in a given year. At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection. However, FDA cannot provide an exact number of foreign establishments that have never been inspected. Most of the foreign inspections performed are conducted as part of a review associated with processing an application to market a new drug, rather than inspections for monitoring the quality of marketed drugs. Although FDA uses a risk-based process to develop a prioritized list of foreign establishments for inspections to monitor the quality of marketed drugs, few are completed in a given year. This prioritized list was used to select foreign establishments for inspection in fiscal year 2007. According to FDA, about 30 such inspections were completed in that year and at least 50 are targeted for inspection in fiscal year 2008. The foreign inspection process involves unique circumstances that are not encountered domestically. For example, FDA relies on staff that inspect domestic establishments to volunteer for foreign inspections. Unlike domestic inspections to monitor the quality of a marketed drug, FDA does not arrive unannounced at a foreign establishment. It also lacks the flexibility to easily extend foreign inspections if problems are encountered, due to the need to adhere to an itinerary that typically involves multiple inspections in the same country. Finally, language barriers can make foreign inspections more difficult than domestic ones. FDA does not generally provide translators to its inspection teams. Instead, they may have to rely on an English-speaking representative of the foreign establishment being inspected, rather than an independent translator.