FDA Conducts Relatively Few Inspections of Foreign Drug Establishments

Although inspections of foreign drug manufacturing establishments— which are intended to assure that the safety and quality of drugs are not  jeopardized by poor manufacturing practices—are an important element  of FDA’s oversight of the supply chain, our previous work has shown that  FDA conducts relatively few inspections of the establishments that it  considers subject to inspection. Specifically, in our 2008 report, we  estimated that FDA inspected 8 percent of such foreign drug  establishments in fiscal year 2007. We estimated that FDA  inspected 11 percent of foreign establishments subject to inspection and  it would take FDA about 9 years to inspect all such establishments at this  rate. FDA’s inspection efforts in fiscal year 2009 represent a   27 percent increase in the number of inspections the agency conducted  when compared to fiscal year 2007—424 and 333 inspections,  respectively. For example, in fiscal year 2009, FDA conducted 1,015  domestic inspections, inspecting approximately 40 percent of domestic  establishments. To address these  discrepancies, we recommended that FDA conduct more inspections to  ensure that foreign establishments manufacturing drugs currently  marketed in the United States are inspected at a frequency comparable to  domestic establishments with similar characteristics. FDA agreed that  the agency should be conducting more foreign inspections, but FDA  officials have since acknowledged that the agency is far from achieving  foreign drug inspection rates comparable to domestic inspection rates  and, without significant increases to its inspectional capacity, the  agency’s ability to close this gap is highly unlikely. In addition to conducting few foreign drug manufacturing inspections, the  types of inspections FDA conducts generally do not include all parts of  the drug supply chain. Specifically, as we identified in our 2008 report on FDA’s foreign  drug inspections, FDA continues to experience challenges related to  limits on the agency’s ability to require foreign establishments to allow the  agency to inspect their facilities. FDA Lacks Complete Information on Foreign Drug Establishments

Our previous reports indicated that FDA has experienced challenges  maintaining complete information on foreign drug manufacturing  establishments. This lack of information, which is critical to understanding  the supply chain, hampers the agency’s ability to inspect foreign  establishments. However, we  found that these databases contained incorrect information about foreign  establishments and did not contain an accurate count of foreign  establishments manufacturing drugs for the U.S. market. Since then, FDA has taken steps to address these deficiencies and  improve the information it receives from both the registration and import  databases, though these efforts have not yet fully addressed the  concerns we raised in 2008. Recent FDA Initiatives to Improve Oversight of the Supply Chain

Given the difficulties that FDA has faced in inspecting and obtaining  information on foreign drug manufacturers, and recognizing that more  inspections alone are not sufficient to meet the challenges posed by  globalization, the agency has begun to explore other initiatives to improve  its oversight of the drug supply chain. We reported that FDA’s overseas  offices had engaged in a variety of activities to help ensure the safety of  imported products. We recommended that FDA enhance  its strategic planning and develop a workforce plan to help recruit and  retain overseas staff and FDA concurred with our recommendations. FDA is also developing initiatives that would assist its oversight of  products at the border. FDA also identified statutory changes that would help improve its  oversight of drugs manufactured in foreign establishments. These include  authority to (1) suspend or cancel drug establishment registrations to  address concerns, including inaccurate or out-of-date information;   (2) require drug establishments to use a unique establishment identifier;  and (3) implement a risk-based inspection process, with flexibility to  determine the frequency with which both foreign and domestic  establishments are inspected, in place of the current requirement that  FDA inspect domestic establishments every 2 years. Concluding Observations

Globalization has fundamentally altered the drug supply chain and  created regulatory challenges for FDA. In light of the growing dependence upon drugs  manufactured abroad and the potential for harm, FDA needs to act  quickly to implement changes across a range of activities in order to  better assure the safety and availability of drugs for the U.S. market. Drug Safety: FDA Has Conducted More Foreign Inspections and Begun  to Improve Its Information on Foreign Establishments, but More Progress  Is Needed. GAO-10-961. Food and Drug Administration: Overseas Offices Have Taken Steps to  Help Ensure Import Safety, but More Long-term Planning Is Needed. GAO-10-960. Medical Devices: FDA Faces Challenges in Conducting Inspections of  Foreign Manufacturing Establishments.
Why GAO Did This Study

Globalization has placed increasing demands on the Food and Drug Administration (FDA) in ensuring the safety and effectiveness of drugs marketed in the United States. The pharmaceutical industry has increasingly relied on global supply chains in which each manufacturing step may be outsourced to foreign establishments. As part of its efforts, FDA may conduct inspections of foreign drug manufacturing establishments, but there are concerns that the complexity of the drug manufacturing supply chain and the volume of imported drugs has created regulatory challenges for FDA. FDA has begun taking steps to address some of these concerns, such as the establishment of overseas offices. This statement discusses (1) FDA's inspection of foreign drug manufacturing establishments, (2) the information FDA has on these establishments, and (3) recent FDA initiatives to improve its oversight of the supply chain. The statement presents findings based primarily on GAO reports since 2008 related to FDA's oversight of the supply chain. These reports include Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed ( GAO-10-960 , Sept. 30, 2010) and Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed ( GAO-10-961 , Sept. 30, 2010). GAO supplemented this prior work with updated information obtained from FDA in August and September 2011.

What GAO Found

Inspections of foreign drug manufacturers are an important element of FDA's oversight of the supply chain, but GAO's prior work showed that FDA conducts relatively few such inspections. In 2008, GAO reported that in fiscal year 2007 FDA inspected 8 percent of foreign establishments subject to inspection and estimated that, at that rate, it would take FDA about 13 years to inspect all such establishments. GAO recommended that FDA increase the number of foreign inspections it conducts at a frequency comparable to domestic establishments with similar characteristics. FDA subsequently increased the number of foreign establishment inspections. FDA's inspection efforts in fiscal year 2009 represent a 27 percent increase in the number of inspections it conducted, when compared to fiscal year 2007--424 and 333 inspections, respectively. However, FDA officials acknowledged that FDA is far from achieving foreign drug inspection rates comparable to domestic inspection rates--the agency inspected 1,015 domestic establishments in fiscal year 2009. Also, the types of inspections FDA conducts generally do not include all parts of the drug supply chain. Conducting inspections abroad also continues to pose unique challenges for the agency. For example, FDA faces limits on its ability to require foreign establishments to allow it to inspect their facilities. Furthermore, logistical issues preclude FDA from conducting unannounced inspections, as it does for domestic establishments. GAO previously reported that FDA lacked complete and accurate information on foreign drug manufacturing establishments--information critical to understanding the supply chain. In 2008, GAO reported that FDA databases contained incorrect information about foreign establishments and did not contain an accurate count of foreign establishments manufacturing drugs for the U.S. market. FDA's lack of information hampers its ability to inspect foreign establishments. GAO recommended that FDA address these deficiencies. FDA has taken steps to do so, but has not yet fully addressed GAO's concerns. Given the difficulties that FDA has faced in inspecting and obtaining information on foreign drug manufacturers, and recognizing that more inspections alone are not sufficient to meet the challenges posed by globalization, the agency has begun to implement other initiatives to improve its oversight of the drug supply chain. FDA's overseas offices have engaged in a variety of activities to help ensure the safety of imported products, such as training foreign stakeholders to help enhance their understanding of FDA regulations. GAO recommended that FDA enhance its strategic and workforce planning, which FDA agreed it would do. FDA has also taken other positive steps, such as developing initiatives that would assist its oversight of products at the border, although these are not yet fully implemented. Finally, FDA officials identified statutory changes that FDA believes it needs to help improve its oversight of drugs manufactured in foreign establishments. For example, in place of the current requirement that FDA inspect domestic establishments every 2 years, officials indicated the agency would benefit from a risk-based inspection process with flexibility to determine the frequency with which both foreign and domestic establishments are inspected. In light of the growing dependence upon drugs manufactured abroad and the potential for harm, FDA needs to act quickly to implement changes across a range of activities in order to better assure the safety and availability of drugs for the U.S. market.