	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. FDA uses multiple databases to manage its foreign drug inspection  program. DRLS contains information on foreign and domestic drug establishments  that have registered with FDA to market their drugs in the United States. In November 2007, we testified on preliminary findings that identified  weaknesses in FDA’s program for inspecting foreign establishments  manufacturing drugs for the U.S. market. We also testified that FDA inspected relatively few foreign  establishments. However, FDA could not provide an exact number of foreign  establishments that had never been inspected. We also testified that FDA’s foreign inspection process involves unique  circumstances that are not encountered domestically. Recent Initiatives May Help FDA Select Foreign Establishments for Inspection, but Weaknesses in Its Foreign Drug Inspection Program Are Not Fully Addressed

FDA has initiated several recent changes to its foreign drug inspection  program, but the changes do not fully address the weaknesses that we  previously identified. FDA is also  pursuing initiatives that could address some of the challenges that we  identified as being unique to foreign inspections, but implementation  details and timeframes associated with these initiatives are unclear. FDA Initiatives Could Improve Its Data, but Will Not Ensure an Accurate Count of Foreign Establishments Subject to Inspection

FDA has initiatives underway to reduce inaccuracies in its databases, but  actions taken thus far will not ensure that the agency has an accurate  count of establishments subject to inspection. In addition to changes to improve DRLS, FDA has supported a proposal  that has the potential to address weaknesses in OASIS, but FDA does not  control the implementation of this change. FDA Initiatives to Obtain Information on Foreign Establishments May Have Limited Impact on Its Selection of Establishments to Inspect

FDA has taken steps to help it select establishments for inspection by  obtaining information on foreign establishments from regulatory bodies in  other countries, despite encountering difficulties in fully utilizing these  arrangements in the past. FDA officials stated that,  in the past, they encountered difficulties using inspection reports from  other countries that were not readily available in English. However, the agency still inspected less than   11 percent of the foreign establishments on the prioritized list that it used  to plan its fiscal year 2007 GMP surveillance inspections. FDA officials  estimated that the agency conducted about 30 such inspections in fiscal  year 2007 and plans to conduct at least 50 in fiscal year 2008. In fiscal  year 2007, FDA dedicated about $10 million to inspections of foreign  establishments. Initially, FDA plans to establish a foreign office in China with  three locations—Beijing, Shanghai, and Guangzhou—comprised of a total  of eight FDA employees and five Chinese nationals. While the establishment of  both a foreign inspection cadre and offices overseas have the potential for  improving FDA’s oversight of foreign establishments and providing the  agency with better data on foreign establishments, it is too early to tell  whether these steps will be effective or will increase the number of foreign  drug inspections. Agreements with foreign governments, such as one recently reached with  China’s State Food and Drug Administration, may help the agency address  certain logistical issues unique to conducting inspections of foreign  establishments. Given the growth in foreign drug manufacturing for the U.S. market and  the current large gaps in FDA’s foreign drug inspections, FDA will need to  devote considerable resources to this area if it is to increase the rate of  inspections.
Why GAO Did This Study

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. FDA inspects foreign establishments to ensure that they meet the same standards required of domestic establishments. Ongoing concerns regarding FDA's foreign drug inspection program recently were heightened when FDA learned that contaminated doses of a common blood thinner had been manufactured at a Chinese establishment that the agency had never inspected. FDA has announced initiatives to improve its foreign drug inspection program. In November 2007, GAO testified on weaknesses in FDA's foreign drug inspection program (GAO-08-224T). This statement presents preliminary findings on how FDA's initiatives address the weaknesses GAO identified. GAO interviewed FDA officials and analyzed FDA's initiatives. GAO examined reports and proposals prepared by the agency, as well as its plans to improve databases it uses to manage its foreign drug inspection program.

What GAO Found

Recent FDA initiatives--some of which have been implemented and others proposed--could strengthen FDA's foreign drug inspection program, but these initiatives do not fully address the weaknesses that GAO previously identified. GAO testified in November 2007 that FDA's databases do not provide an accurate count of foreign establishments subject to inspection and do provide widely divergent counts. Through one recent initiative, FDA has taken steps to improve its database intended to include foreign establishments registered to market drugs in the United States. This initiative may reduce inaccuracies in FDA's count of foreign establishments. However, these steps will not prevent foreign establishments that do not manufacture drugs for the U.S. market from erroneously registering with FDA. Further, to reduce duplication in its import database, FDA has supported a proposal that would change the data it receives on products entering the United States. However, the implementation of this proposal is not certain and would require action from multiple federal agencies, in addition to FDA. Efforts to integrate these databases have the potential to provide FDA with a more accurate count of establishments subject to inspection, but it is too early to tell. GAO testified that gaps in information weaken FDA's processes for prioritizing the inspection of foreign establishments that pose the greatest risk to public health. While FDA recently expressed interest in obtaining useful information from foreign regulatory bodies that could help it prioritize foreign establishments for inspections, the agency has faced difficulties fully utilizing these arrangements in the past. For example, FDA had difficulties in determining whether the scope of other countries' inspection reports met its needs and these reports were not always readily available in English. GAO also testified that FDA inspected relatively few foreign establishments each year. FDA made progress in inspecting more foreign establishments in fiscal year 2007, but the agency still inspects far fewer of them than domestic establishments. FDA dedicated about $10 million to foreign drug inspections in fiscal year 2007 and plans to dedicate about $11 million to such inspections in fiscal year 2008. Finally, GAO testified that FDA faced certain logistical and staffing challenges unique to conducting foreign inspections. FDA is pursuing initiatives that could address some of the challenges that we identified as being unique to foreign inspections, such as volunteer inspection staff and lack of translators. FDA has proposed establishing a dedicated cadre of staff to conduct foreign inspections, but the timeframe associated with this initiative is unclear. FDA plans to open an office in China and is considering establishing offices in other countries, but the impact that this will have on the foreign drug inspection program is unknown.