Several FDA centers and offices play key roles in helping to ensure the safety and effectiveness of drugs marketed in the United States: CDER establishes standards for the safety, quality, and effectiveness of and manufacturing processes for over-the-counter and prescription drugs. OIP, which is part of FDA’s Office of Global Regulatory Operations and Policy, leads, manages, and coordinates FDA’s foreign offices’ activities, such as performing inspections in the countries in which the offices reside. OIP also engages with international health and regulatory partners on a variety of issues, including establishing confidentiality agreements with regulatory counterparts for sharing information on regulated products, and collaborates with the staff in FDA’s centers and ORA. ORA inspects establishments and reviews imported products offered for entry into the United States to ensure compliance with applicable laws and regulations, among other things. ORA is also part of FDA’s Office of Global Regulatory Operations and Policy. FDA conducts several types of inspections of drug manufacturing establishments to protect the drug supply. Drugs manufactured overseas must generally meet the same statutory and regulatory requirements as those produced in the United States. CDER and ORA are primarily responsible for the agency’s human drug inspection program. CDER requests ORA to inspect both domestic and foreign establishments to ensure that drugs are produced in conformance with federal statutes and regulations, including CGMP regulations. ORA investigators (based domestically and in the foreign offices) and, as needed, laboratory analysts are responsible for conducting the inspections. Investigators generally conduct three types of drug manufacturing establishment inspections: 1. Preapproval inspections of domestic and foreign establishments may be conducted before FDA approves a new drug to be marketed in the United States. These inspections are triggered by FDA’s receipt of a new drug application or an abbreviated new drug application, and focus on the manufacture of a specific drug. Preapproval inspections are designed to verify the accuracy and authenticity of the data contained in these applications to determine that the establishment is following commitments made in the application. Preapproval inspections also assess whether the establishment can manufacture the product in the application in conformance with CGMPs. FDA’s decision to inspect a particular establishment listed on the application is based on multiple factors, including the establishment’s compliance history—that is, the results of previous inspections, product recalls, and other compliance information—and the attributes of the product being proposed for manufacture. 2. Surveillance inspections are conducted at establishments after drugs are already marketed in the United States and focus on compliance with system-wide controls for ensuring that the manufacturing processes produce high-quality drugs. Establishments are prioritized for surveillance inspections through a process using a risk-based site selection model. Systems examined during these inspections include those related to materials, quality control, production, facilities and equipment, packaging and labeling, and laboratory controls. These systems may be involved in the manufacture of multiple drugs. FDA can use the results of a surveillance inspection to make decisions in the future if the establishment is listed on another application, as the results of a surveillance inspection can often be generalized to all drugs manufactured in a similar manner at a particular establishment. 3. For-cause inspections are conducted to investigate consumer complaints, reports of product quality defects submitted by consumers or health care professionals, or indications of potential manufacturing problems submitted by the manufacturers themselves through field alert reports, among other reasons. Additionally, these inspections may also be conducted as follow-up to warning letters or import alerts issued to manufacturers. While FDA may conduct a preapproval-only inspection or a surveillance- only inspection, FDA may also conduct an inspection that combines both preapproval and surveillance inspection components in a single visit to an establishment. FDA uses multiple databases to select foreign and domestic establishments for surveillance inspections, including The electronic Drug Registration and Listing System (eDRLS) contains information on foreign and domestic drug establishments that have registered with FDA to market their drugs in the United States. Establishments are required to register annually with FDA. Information in eDRLS includes the company’s name, address, and the drugs they manufacture for commercial distribution in the United States, as reported by the establishment. FACTS contains information on domestic and foreign establishments inspected by ORA, the type of inspection conducted, and the outcome of those inspections. Investigators and laboratory analysts enter information into FACTS following completion of an inspection. CDER relies on these and other databases to select establishments for surveillance inspections. CDER primarily uses data from eDRLS, which provides information on all registered establishments at a given point in time, and FACTS, which provides information about additional establishments that may not appear in eDRLS, to annually compile a catalog of establishments that are to be prioritized for inspection. Because the establishments to be prioritized are continuously changing as they begin, stop, or resume marketing products in the United States, FDA does not maintain a single list of them; rather, the annual catalog provides a snapshot in time of such establishments. Based on these databases, as of June 2016, CDER’s catalog consisted of approximately 2,000 domestic and 3,000 foreign drug establishments. Until 2012, requirements governing FDA’s selection of domestic and foreign establishments to inspect differed. Until then, FDA was required to inspect domestic establishments that manufacture drugs marketed in the United States every 2 years, but there was no comparable requirement for inspecting foreign establishments. However, FDASIA eliminated this distinction, instead directing FDA to take a risk-based approach to inspecting both domestic and foreign drug manufacturing establishments, consistent with a recommendation we made to FDA in 2008. To prioritize establishments for surveillance inspections, CDER applies its risk-based site selection model to its catalog of establishments each year to identify those establishments (both domestic and foreign) that, based on the characteristics of the drugs being manufactured, pose the greatest potential public health risk should they experience a manufacturing defect. This model analyzes three major factors—facility score, product score, and time since last inspection—to develop a list of establishments that FDA considers to be a priority for inspection. Establishments may also be selected for surveillance inspections for other reasons, such as FDA’s focus on a particular product. Through this process, CDER develops a priority list of establishments selected for inspection that is then ranked and submitted to ORA. To be efficient with its resources, ORA staff may shift the order of establishments to be inspected on CDER’s prioritized list based on geographic proximity to other planned inspection trips. FDA opened its foreign offices in 2008 to engage with foreign stakeholders to develop information that FDA officials can use to make better decisions about products manufactured in foreign countries for the U.S. market. To accomplish this, the foreign offices focus on the following activities: 1. establishing relationships with U.S. agencies located overseas and foreign stakeholders, including regulatory counterparts and industry, to facilitate collaborations that will streamline and enhance global drug development and regulation; 2. gathering better information locally on product manufacturing and transport to U.S. ports; 3. expanding FDA’s inspectional capacity to include inspections of FDA- regulated commodities, such as drugs, medical devices, and food products, conducted by investigators based in the foreign offices; and 4. providing assistance to strengthen the regulatory systems of FDA’s foreign counterparts to better assure the safety of the products manufactured and exported from their countries to the United States. Currently, FDA has foreign offices in China, Europe, India, and Latin America. Some offices have more than one office location, also known as a post. (See fig. 1.) FDA previously had foreign offices located in Africa and the Middle East, but these offices have since closed and been consolidated under the Office of Regional and Country Affairs, an OIP office based domestically in FDA’s headquarters. For fiscal year 2016, FDA budgeted approximately $35.2 million for the China, Europe, India, and Latin America offices, an increase over the $29.9 million budgeted for them in fiscal year 2009. As of July 2016, FDA had 29 staff members assigned to work in the foreign offices, including a director and deputy director in each office. The offices also have international program and policy analysts who analyze the impact of foreign issues on FDA programs and activities, and other staff who are responsible for engaging with foreign stakeholders and gathering information. There are also investigators who conduct inspections of establishments manufacturing food or medical products in the China, India, and Latin America offices. The offices also have locally employed staff, who are non-U.S. citizens employed by the FDA foreign offices. Finally, OIP staff based in its domestic offices assist the foreign offices in addition to performing other duties related to advancing FDA’s global mission. FDA foreign office staff are posted overseas for two-year assignments. In addition, FDA may send staff to the foreign offices to perform temporary duty assignments of up to 120 days. HHS policy requires that its overseas staff commit to assignments of no more than 2 years per tour; however, staff have the option to renew in increments of one or two years, for up to a total of 6 years in one country, subject to strategic goals and management concurrence on performance. Staff can then rotate to a new country, but HHS requires that staff spend no more than 12 consecutive years overseas before returning to the United States for at least 1 year. Since fiscal year 2009, FDA has increased the number of all foreign drug inspections conducted each year. Additionally, the agency has taken steps to improve the accuracy and completeness of its catalog of foreign drug establishments, although FDA still lacks inspection history for 33 percent of this catalog. FDA has also strengthened the management of its process for prioritizing drug establishments for surveillance inspection, in particular its risk-based site selection model. FDA has consistently increased the total number of foreign drug inspections—which include surveillance, preapproval, and for-cause inspections—conducted each year since fiscal year 2009, as shown in figure 2. This is consistent with a recommendation we made in 2008, when we recommended that FDA conduct more inspections to ensure that foreign drug establishments are inspected at a frequency comparable to domestic establishments with similar characteristics. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspections. According to FDA officials, the agency has leveraged multiple staff resources to enable it to increase the number of foreign drug inspections conducted by the agency in recent years. ORA investigators based in FDA’s domestic district offices continue to represent the majority of people participating in FDA’s foreign inspections (approximately 49 percent of the total number of inspections conducted). As we previously reported, though, FDA established a dedicated foreign drug cadre in January 2009. The group of 15 domestically based ORA staff exclusively participate in foreign drug inspections. FDA told us that the agency increased the number of staff assigned to the foreign cadre to 20 in 2012. Currently, the foreign cadre represents the next highest percent of staff participating in foreign inspections (approximately 31 percent of total inspections). Additionally, the Generic Drug User Fee Amendments Act (GDUFA) of 2012 authorized FDA to collect user fees from manufacturers of generic drugs, providing the resources to hire 80 additional investigators focused on inspecting generic drug manufacturers. FDA officials said that these investigators have primarily been assigned to foreign inspections, but during the period we reviewed, they participated in a relatively small percentage of the total number of foreign drug inspections conducted (approximately 8 percent of inspections). Investigators assigned full-time to FDA’s foreign offices have also participated in inspections of foreign drug establishments (approximately 5 percent of inspections). Since fiscal year 2012, the foreign offices have also made use of temporary duty assignments from ORA to assist the foreign offices in completing their work priorities, including inspections. Staff on temporary duty assignments have participated in approximately 2 percent of foreign drug inspections. In addition, there are a variety of other FDA staff who, on occasion, may participate in an inspection if certain subject matter expertise is needed. In addition to using various FDA staff to conduct foreign inspections, the agency has increased funding dedicated to conducting foreign inspections. According to FDA officials, the agency obligated approximately $53 million to foreign inspections in fiscal year 2010. This amount has increased each year since, to $92 million in fiscal year 2015. The average cost of a foreign drug inspection has slightly decreased over the years. FDA had estimated that the average cost of a foreign inspection was between $60,000 and $62,500 for fiscal year 2009; for fiscal year 2015, the average cost was $57,600. The locations where FDA has conducted foreign inspections have largely remained the same from what we previously reported. Specifically, FDA conducted drug inspections in 68 total countries from fiscal year 2010 and June 30, 2016, with 76 percent of these inspections conducted in 10 countries. Establishments in India were the most frequently inspected, followed by ones in China and Germany. (See table 1.) This mirrors what we previously found in 2010. Since 2009, FDA has changed the types of inspections it primarily conducts at foreign drug establishments. Specifically, more than half (55 percent) of all foreign inspections conducted from fiscal year 2010 through June 30, 2016, were surveillance-only inspections rather than preapproval inspections. (See fig. 3.) This is a significant increase since fiscal year 2009, when we found that 17 percent of foreign inspections were surveillance inspections, with the vast majority conducted in response to an application to market a new drug in the United States. FDA officials acknowledged that foreign inspection priorities had previously been driven by pending applications for new drugs. However, this was prior to the enactment of FDASIA, when FDA was required to inspect all domestic establishments every 2 years, and also before an increase in funding available for foreign inspections provided for by generic drug user fees. FDA officials also said the agency eliminated a policy whereby inspections conducted for preapproval purposes often drove the selection of foreign establishments for inspections. As a result, FDA officials said that the selection of foreign establishments for routine surveillance inspections is now entirely driven by the risk-based site selection model. (See app. I for information on the number and types of foreign drug inspections conducted from fiscal year 2010 through June 30, 2016.) Since 2010, FDA has taken steps to improve the accuracy and completeness of its catalog of foreign drug establishments. These steps are intended to address what FDA acknowledged as a challenge as early as 1988, following an internal evaluation that recommended that the agency develop a comprehensive catalog of all foreign establishments shipping drugs to the United States that could be used to improve long- range inspection planning and scheduling. We also highlighted this challenge in our previous reports. Most recently, in 2010, we found that a majority (64 percent) of foreign establishments in FDA’s catalog may never have been inspected by the agency. Since then, FDA officials said that the agency has taken steps to improve the accuracy and completeness of its catalog by Requiring establishments to use a unique, numeric identifier. FDASIA required establishments to provide a unique facility identifier during their annual registration with FDA, and FDA elected to require establishments to use the Dun and Bradstreet Data Universal Numbering System (D-U-N-S®) number. Using this number allows FDA to automatically validate data from every registration submission against the Dun and Bradstreet database to ensure the accuracy of the information. Any mismatch may result in rejection of a registration submission. The D-U-N-S® number also allows FDA to determine whether a firm has gone out of business or relocated. FDA officials said that it has also helped FDA improve the interoperability of the agency’s data systems that collect or use registered facility information, as well as the interoperability of other agencies’ systems. Adding two foreign inventory coordinators in 2013 tasked with incorporating foreign registrations and annual updates into FDA’s master inventory. Additionally, these coordinators are responsible for updating FDA’s inspection data to reflect accurate inventory updates. Establishing a data governance board to define standards, best practices, and policies for inventory data management. According to FDA officials, the governance board, which was created in May 2015, meets biweekly to examine the databases responsible for storing information about drug establishments. Officials said the board has developed guidance for merging data processes and is working toward defining data metrics to determine whether they have improved on their reporting. The board has also defined data standards for storing key attributes of establishments, such as companies’ names, and continues to examine best practices for sharing establishment data across FDA. As a result of these steps, FDA has reduced its catalog of establishments that may never have had a surveillance inspection. Currently, FDA lacks information on the inspection history of 33 percent of the foreign establishments in its catalog, compared to the 64 percent for which it lacked inspection history in 2010. According to FDA officials, the establishments that are subject to inspections are continuously changing. For example, they said that some of the establishments without an inspection history may be newly registered with the agency, thus accounting for their lack of an inspection history; others could be establishments that are not subject to inspection, such as those that may have gone out of business or that have never shipped products to the United States. Although this may be the case for some—or even many— of these establishments, the fact remains that FDA does not know whether or for how long these establishments have or may have supplied drugs to the U.S. market, and has little other information about them. While the agency has made progress in reducing this knowledge gap, it is important to note that the overall number of foreign establishments with no surveillance inspection history (about 1,000 of the approximately 3,000) remains large. (See app. II for information on the numbers and locations of the establishments for which FDA lacks an inspection history.) To address this persistent concern, the agency plans to inspect all establishments in its catalog with no prior surveillance inspection history over the next 3 years (approximately one-third each year), beginning in fiscal year 2017. FDA will consider these establishments’ risk scores as determined by the agency’s risk-based site selection model to prioritize them for inspection, starting with those establishments having the highest risk scores. Some recent FDA inspections have uncovered significant issues at foreign drug manufacturing establishments, including raw material storage rooms that had never been cleaned and the presence of pests in a controlled processing area, underscoring the importance for FDA to fill this knowledge gap. FDA has strengthened the management of its process for selecting drug establishments (domestic and foreign) for surveillance inspection. First, FDA generated a combined list of foreign and domestic establishments for use with the fiscal year 2016 risk-based sited selection model. Using a combined list of establishments with the risk-based site selection model reflects the agency’s full implementation of the 2012 FDASIA provision that directed FDA to take a risk-based approach to inspecting both foreign and domestic establishments. This is also consistent with a recommendation we made to the agency in 2008. For fiscal year 2016 and beyond, FDA officials said that ORA will only select establishments for surveillance inspection from the combined prioritized list—beginning with those establishments with the highest risk score, regardless of whether they are foreign or domestic—until they have exhausted their surveillance inspection capacity for that year. Prior to fiscal year 2016, foreign and domestic establishments were selected for inspection from separate prioritized lists, and in different manners. As a result, during this time, FDA officials said that a one-for-one match between the lists of foreign establishments prioritized for inspection and the final list of actual inspections conducted would be unlikely. Officials said that the prioritized lists of foreign establishments for fiscal year 2010 through fiscal year 2015 provided a framework for planning surveillance inspections, but that ORA was given discretion as to which specific establishments from the priority list would be inspected each year. Collectively, FDA officials said that the results from the priority list, the needs of the centers, and any unforeseen events dictated the final list of foreign establishments inspected prior to fiscal year 2016, and the final list could differ from the priority list generated by the risk-based site selection model. Second, in 2015, the agency formalized its process for selecting establishments for inspection according to an establishment’s known safety risks, based on certain risk factors specified by FDASIA. These factors are an establishment’s compliance history, recall history, inherent product risk, inspection frequency and history, and whether the establishment has been inspected by a foreign government or agency. FDA officials said that the agency has long considered certain FDASIA factors in selecting establishments to inspect, such as an establishment’s inspection history. However, its risk-based site selection model has become increasingly sophisticated in factoring in specific details about establishments, the products they make, and other elements into the site selection process. Officials acknowledged that FDA cannot yet systematically determine whether an establishment has been subject to inspection by a foreign government or agency, because this requires the agency to negotiate agreements with foreign regulators to obtain meaningful foreign inspection results. Officials stated that FDA is in the process of doing so. However, FDA has been working on pursuing such agreements and determining how they may help the agency to assess the risk of foreign establishments when prioritizing them for almost a decade. As they continue to explore these agreements, FDA officials said the agency does, on a case-by-case basis, review and exchange information with certain foreign regulators, which may result in the agency re-prioritizing its inspection schedule to address emergent issues. Third, in fiscal year 2017, FDA plans for the first time to allow no more than 5 years to elapse between surveillance inspections at a specific establishment. That is, if an establishment included in FDA’s catalog of establishments subject to inspection has not been inspected in 4 years, the establishment is automatically included on the inspection list for the fifth year. According to FDA officials, the agency previously did not include a “hard stop” of a predetermined time in its model. For fiscal year 2017, after FDA inspects one-third of the establishments with no inspection history the agency will prioritize for inspection these establishments that have not had a surveillance inspection within the past 5 years. Once these inspections are completed, FDA plans to inspect establishments that were prioritized by the risk-based site selection model through its annual process. Should FDA complete inspections of all of the establishments prioritized through the risk-based site selection model, the agency plans to conduct additional inspections of as many of the remaining two-thirds of establishments with no inspection history as possible, given remaining inspection resources. Fourth, FDA recently formalized its process for developing, evaluating, and documenting key decisions about its model each year. Prior to this effort, FDA lacked a formal approach to evaluating its model and documenting key decisions. As a result, in some cases, FDA was unable to recall or explain how the model—or the process to update it—had changed over time. Officials said that our prior reviews reinforced the need for a written procedure and a formal governance structure to support the development of the risk-based site selection model. In fiscal year 2016, FDA instituted a formalized process for developing and evaluating its fiscal year 2017 model and documenting key decisions made as a result of this evaluation. As part of this process, FDA created a review board that features multiple levels of input of the model’s design from FDA experts and senior management, and in October 2016 finalized a document that outlines roles and responsibilities related to the model, and that indicates how it is to be annually updated and implemented. FDA also incorporated best practices learned from its first experience using the review board to guide the development of the model. Officials said the document, going forward, will chronicle the decisions officials make regarding which factors were included in the model for a particular year and why. FDA’s formalized process for evaluating and updating its risk- based site selection model may improve the agency’s ability to monitor whether establishments that pose the greatest risk to public health, were they not to comply with CGMPs, are being selected for inspection. FDA is performing monitoring activities through its formalized process by annually updating the factors and weights included in the model through its newly formalized governance structure. This process allows subject matter experts to provide input each year on the relative importance of each factor and whether the factor should be included in the model. FDA has begun to take steps to enhance the agency’s strategic planning for the foreign offices and has developed two performance measures. However, FDA could not readily cite the effectiveness of the offices’ contributions, which began opening in 2008. High vacancy rates in the foreign offices threaten to impede the offices’ efforts to ensure drug safety. FDA has made progress in its strategic planning efforts for its foreign offices since we last reported on them in 2010. For example, FDA has standardized how the foreign offices relay information about their activities. Specifically, each foreign office now completes an annual operational plan—updated quarterly—to ensure their activities are consistently reported and to facilitate tracking the outcomes of their efforts. Foreign office officials said that they worked closely together to align the core activities listed in the operational plans with OIP’s strategic goals to improve officials’ understanding of how each foreign office contributes to fulfilling OIP’s mission of helping protect public health. For example, the plans include examples of activities related to data gathering, analysis, and information sharing, which support one of OIP’s strategic goals of collecting and sharing intelligence and information. Officials said they use the operational plans to track whether the foreign offices’ annual accomplishments are fulfilling OIP’s goals, and noted that having a common operational plan across the offices allows for a common language amongst officials when discussing their efforts. In addition, FDA officials noted they have taken the step of convening the foreign office directors and deputy directors at FDA headquarters at least once a year since 2010 to discuss their ongoing efforts and exchange best practices with each other, with the most recent convening occurring in April 2016. FDA officials also said that communication between the foreign offices and other FDA offices, including CDER and ORA, has increased over the years. For example, officials told us that OIP management and the foreign office directors and deputy directors have been meeting three times per month to ensure that the foreign offices are obtaining the types of information that would be most helpful in ensuring the safety of drugs entering the United States. FDA has begun to take steps in response to two recommendations we previously made to enhance the agency’s strategic planning for the foreign offices. Specifically, we recommended in 2010 that FDA develop (1) performance goals and measures that can be used to demonstrate the offices’ contributions to long-term outcomes related to imported FDA- regulated products; and (2) a strategic workforce plan for the foreign offices to help ensure that the agency is able to recruit and retain staff with the experience and skills necessary for the foreign offices, and to reintegrate returning staff from overseas into FDA’s domestic offices. Since then, OIP has developed two performance measures with established targets—number of inspections conducted by full-time medical product investigators at foreign offices and number of collaborative actions by OIP—that are used to assess the foreign offices’ contributions. According to FDA, the agency met its collective targets for these measures for fiscal year 2015. First, regarding the number of inspections by foreign office staff, FDA set a performance measure in fiscal year 2016 for full-time medical product investigators assigned to the China, India, and Latin America offices for each to conduct 15 medical product inspections. In other words, if there were two medical product investigators assigned to the China office, their target for the year would be 30 medical product inspections. Moreover, according to FDA, this goal applies to not only drugs, but all FDA medical product inspections, including medical devices and bioresearch monitoring inspections. There is not a specific “drug inspection” performance measure, although in practice, foreign office investigators are assigned a specific commodity (for example, food, drugs, or medical devices) to inspect. Depending on the current staffing composition, foreign office investigators could meet their target of 15 medical product inspections by inspecting establishments manufacturing medical products other than drugs. Although FDA opened foreign offices abroad, in part, to help improve FDA’s capacity to conduct foreign inspections, the staff in those offices have conducted relatively few drug inspections since fiscal year 2010. Specifically, of the total number of drug inspections conducted between fiscal year 2010 and June 30, 2016 (4,384), investigators assigned full- time to the foreign offices participated in 241 (5 percent) of these inspections. The total number of drug inspections conducted each year by these full-time investigators ranged from 29 to 52, with the India office investigators conducting about two-thirds of the total number of inspections. See table 2 for more information on the number of drug inspections conducted by the foreign offices in India, China, and Latin America. We previously reported in 2010 that FDA did not have a goal for how many inspections it would like foreign office investigators to conduct— although this has since changed with its inspection targets—but that the agency would like to see overall increases in the number of inspections conducted in both China and India. However, in the case of drug inspections, this goal has not yet been fully realized, as the number of inspections conducted by the India office has decreased since fiscal year 2013 and the number of inspections conducted by the China office has only just reached a new high in fiscal year 2016. We understand and previously reported that the China office had difficulty in obtaining visas from the Chinese government for its staff to deploy overseas for several years, which may have contributed to the low number of inspections conducted by the office during these years. FDA appears to have been able to overcome this particular challenge in 2014, and FDA officials told us there has been an overall increase in the total number of authorized foreign office staff who can perform foreign inspections since we reported in 2010. Specifically, in 2010 there were four investigators in the China office and three in the India office. As of July 2016, there were 11 of 18 authorized investigators in China, 3 of 13 authorized investigators in India, and 1 of 2 authorized investigators in the Latin America office, although these additional investigators may be conducting inspections of establishments that manufacture other FDA-regulated products, such as food. For example, according to FDA, in fiscal year 2015, foreign office investigators conducted 150 inspections of food establishments; 79 medical product inspections; and 8 veterinary medicine inspections; for a total of 237 inspections. FDA has also authorized 18 additional investigators for its foreign offices that the agency has yet to fill and of which at least 9 are intended to be assigned to performing drug inspections. Drug inspections may also be conducted by temporary duty staff who are deployed to the foreign offices for 30-, 60-, 90-, or 120-day assignments to, in part, supplement the number of inspections conducted by the foreign offices. From fiscal year 2012, when staff began serving temporary duty in the foreign offices, through June 30, 2016, these staff participated in an additional 105 foreign drug inspections—bringing the total number of inspections in which full-time and temporary foreign office staff participated to 346. (For more information on the number of foreign drug inspections temporary duty staff have performed by year, see app. III.) Regarding the second measure, collaborative actions, FDA set a target of completing 25 such actions for all of OIP for fiscal year 2016, according to FDA officials. The outcomes of this measure have been tracked internally by OIP since fiscal year 2014, when the measure was first implemented. OIP officials told us they use specific criteria to determine whether an activity qualifies as a collaborative action. For example, activities qualify only if they include collaboration with an external stakeholder or U.S. government agency other than FDA. Similarly, inspections conducted by foreign office investigators are excluded (as these are tracked separately) unless a foreign regulatory counterpart participates in the inspection with FDA staff. In addition, activities are excluded if no tangible deliverable or result was identified. FDA reported exceeding its goal of 25 collaborative actions in fiscal year 2015 by 2, for a total of 27 collaborative actions. We identified shortcomings with using the collaborative action measure to assess the foreign offices’ performances. First, the measure and its target are not unique to the foreign offices. According to FDA officials, this measure applies to all of OIP’s offices—both foreign and domestic. When asked about its decision to expand this target to all of OIP, rather than specifically focusing on the foreign offices, officials said that they prefer to adopt a holistic approach to assessing OIP’s contributions. However, in adopting this approach, the measure does not reflect the unique contributions of the foreign offices as they are not distinguished from those made by OIP as a whole. Second, the target of 25 collaborative actions for all OIP does not necessarily target actions that are specific to drug safety-related efforts. FDA officials said the efforts could be focused on any commodity regulated by FDA, such as food and medical devices, meaning that the target could potentially be met without performing a single activity related to enhancing drug safety. Third, the measure is not expressed in terms of an end outcome. End outcomes are the results of programs and activities compared to their intended purpose. In this case, FDA’s collaborative action measure is not expressed in terms of the foreign offices’ purpose of enhancing drug safety. Furthermore, FDA officials—those in the foreign offices who engage in collaborative actions and those at FDA headquarters—acknowledge that it can be difficult to link the results of a foreign office’s actions to enhanced drug safety. Beyond the shortcomings of the collaborative action measure, FDA could not readily cite the overall effectiveness of the offices’ contributions, and it has not completed a thorough assessment of their accomplishments, despite the implementation of the two performance measures within the last six years. Standards for internal control in the federal government call for agencies to have control activities that are designed appropriately to (1) conduct top-level reviews of actual performance, (2) review activities at the activity level, and (3) review performance measures and indicators. While the foreign office staff may be engaged in meaningful activities, the activities cannot be systematically tracked by FDA using the two performance measures currently in place nor, according to officials, does the agency have a process in place to formally assess the offices’ contributions. For example, FDA has not systematically tracked how information obtained from the foreign offices, and subsequently shared with FDA’s centers and offices, contributed to increased drug safety, as such information would only be tracked if obtained in collaboration with foreign stakeholders. Additionally, FDA’s two current performance measures do not capture a range of activities specifically undertaken by the foreign offices that resulted in drug safety related outcomes. Such outcomes could include additional inspections of foreign establishments in their host countries, warning letters to manufacturers in violation of CGMPs, or import alerts for products that appear in violation of FDA regulations. However, we found that the foreign offices were engaging in activities that produced potentially positive outcomes. When asked, FDA officials provided us with the following examples: In 2012, the India office discovered that an Indian establishment had manufactured and distributed API from one of its sites without fulfilling FDA’s registration requirements. The India office shared this information with FDA’s domestic offices and received concurrence to conduct an inspection at the firm’s unregistered establishment, along with the firm’s establishment that was registered with FDA. Inspections at both establishments revealed significant CGMP deficiencies. As a result, FDA issued a warning letter to the firm emphasizing the deficiencies and criticizing, among other things, its lack of oversight. Both establishments are on import alert. In 2013, the India office collected intelligence about an Indian company manufacturing APIs that had been linked to deaths in another country. The company and an affiliate were thought to be manufacturing sub-standard and fraudulent APIs, although FDA could not corroborate this through its own inspections since the U.S. embassy prohibited the agency from doing so due to security concerns. However, the India office followed up with the local government and obtained information about the company’s establishments from the local government inspections. The local government in India had found the company not complying with CGMPs. As a result of the India office’s intelligence gathering, the company and its affiliate were placed on import alert. (See app. IV for examples of activities from each foreign office that may have helped ensure the safety of drugs entering the United States.) However, positive examples such as these are not systematically tracked as they do not meet FDA’s criteria of what constitutes a collaborative action. FDA’s exclusion of activities that may enhance drug safety because they must be performed with a foreign counterpart or other U.S. government agency, for example, is not adequate as it does not include accomplishments made exclusively by foreign office staff, and leaves the agency with no reason to track them. While foreign office investigators have participated in for-cause inspections, for example, FDA officials said there is no tracking of the foreign offices’ actions that led to such inspections in the first place. Therefore, if foreign office staff collect and share intelligence about an establishment in a host country with domestically based FDA staff that results in an action, which spurs a for- cause inspection or detaining a product at the border, this contribution is not assessed by any performance measure. An internal evaluation completed by FDA’s Office of Planning in July 2016 similarly described the need for the foreign offices to make efforts to measure their benefits by recording instances of, for example, shortened recall time, signed FDA-relevant treaties, and other outcome measures. Without tracking how information collected by the foreign offices has resulted in these types of outcomes, FDA does not have reasonable assurance that the foreign offices’ activities have helped ensure the safety of drugs entering the United States. Furthermore, without evidence on the types of outcomes that resulted from information collected by the foreign offices, FDA cannot consider these outcomes and plan accordingly as the agency continues to test new performance measures for the foreign offices. FDA also cannot ensure that it has the correct number of staff deployed with the appropriate skills to perform such activities and enable the foreign offices to help fulfill FDA’s mission overseas. FDA officials explained to us that the foreign offices have not existed for very long and that the changes and progress they have undergone since opening have been “remarkable.” However, the limitations of FDA’s two current performance measures to demonstrate such contributions reinforces the need for FDA to continue exploring new performance measures that will better assess the contributions of the foreign offices. FDA’s July 2016 internal evaluation also described the need for OIP to establish performance measures that are aligned with selected outcomes for each foreign office, and that are tracked on a consistent basis to allow for continuous improvement and management oversight. FDA officials said they are considering using five other measures to assess the performance of its foreign offices that are currently included in the foreign offices’ operational plans. However, these measures have not yet been adopted. FDA considered these measures to be in the testing phase for fiscal year 2016, and said it plans to evaluate them in fiscal year 2017. Persistently high vacancy rates in FDA’s foreign offices threaten to impede the offices’ efforts to ensure drug safety. Our concerns extend back to 2010, when we reported that FDA had experienced challenges in staffing some of the foreign offices. For example, at that time, FDA had 2 vacant staff positions in the Latin America office out of a total of 14 positions (14 percent), and 4 vacancies in the India office out of a total of 15 positions (27 percent). In subsequent years, the number of vacancies in the foreign offices has increased. We later found that these rates were considerably higher—44 percent overall—as of October 2014. This high vacancy rate has persisted. As of July 2016, the foreign offices were authorized to have 54 full-time positions overseas, but 25 of these positions (46 percent) were vacant. The India office has the highest vacancy rate at 68 percent (13 vacancies), followed by the Latin America office at 43 percent (3 vacancies), the Europe office at 33 percent (1 vacancy), and the China office at 32 percent (8 vacancies). (See fig. 4 for an analysis of vacancies by foreign office.) Across all foreign offices, the position with the greatest proportion of vacancies is international program policy analysts, who analyze the impact of foreign issues on FDA programs and activities (6 of 10 authorized positions are vacant), followed by investigators, who conduct inspections (18 of 33 authorized positions are vacant). (See table 3.) Given that one of the reasons for opening the foreign offices was to conduct inspections, the large number of vacant investigators is concerning. FDA officials have stressed that there are significant benefits to having investigators stationed overseas. For example, officials noted that foreign office investigators can remain at an inspection site longer, if necessary, as they are not limited by travel arrangements to return to the United States. They can also initiate for-cause inspections more quickly than their domestic counterparts, as they are already in country. Former foreign office staff that we spoke with noted that the ability of foreign office investigators to conduct inspections quickly in response to emergencies is a great advantage of having FDA offices overseas. Former foreign office staff also said that it was valuable for investigators to be able to focus on their host country’s manufacturers, and to better understand how they satisfy CGMPs or their difficulties with doing so. FDA acknowledged that recruiting and hiring staff for OIP, especially for the foreign offices, can be challenging, but that it is critical for achieving FDA’s global mission. FDA’s Office of Planning recently proposed a process for selecting foreign office locations and determining the correct mix of staffing and position types for them. However, the Office of Planning’s proposal did not contain suggestions for overcoming high vacancy rates in the foreign offices. OIP has yet to implement this proposed process. OIP officials based in the United States and in the foreign offices cited several factors contributing to the foreign offices’ persistently high vacancy rate. Although some of these factors may be beyond the agency’s ability to resolve, others are issues we cited in our 2010 and 2015 reports that continue to challenge FDA. Specifically, FDA officials said the following factors contribute to FDA’s difficulty in filling its full-time positions overseas: Length of time to be cleared for deployment: Officials estimated that it takes approximately 9 to 12 months to complete the overseas deployment process, which includes, among other things, obtaining the appropriate security clearance for the employee, as well as medical clearances for the employee and any dependents who will be accompanying the employee overseas. Former foreign office staff that we spoke with confirmed that the deployment process could be quite lengthy, and two former staff specifically mentioned experiencing challenges navigating the process. We reported on these challenges in both 2010 and 2015. FDA officials explained that there is little they can do to expedite this timeframe given the length of time involved to obtain necessary security and medical clearances required to work abroad. Furthermore, the process involves other government stakeholders, such as the Department of State, which is responsible for the medical clearances, limiting FDA’s ability to control the deployment timeframe. Reintegration into FDA’s domestic offices: Our discussions with former foreign office staff who have since returned to FDA’s domestic offices or left the agency following their time spent overseas confirm that challenges reintegrating into FDA persist. For example, some former foreign office staff reported having to find a job in a domestic office on their own, or who faced considerable uncertainty about what their new role in the agency would be. Several also noted that the skills they developed abroad were not being leveraged, and indicated that there was no effort by FDA management or OIP to debrief them upon their return. For example, a former policy analyst said he developed a unique set of skills for working with foreign regulators on potential drug safety issues that were no longer being leveraged by the agency once he returned to a domestic position. A former investigator, meanwhile, said he had developed a unique set of skills for determining whether establishments were falsifying their records, but it was unclear how he could best share these skills with other investigators upon his return to the United States. We reported on concerns about such challenges in both 2010 and 2015, and recommended in 2010 that FDA develop a strategic workforce plan to, in part, help ensure that the agency was able to reintegrate returning foreign office staff into FDA’s domestic offices. FDA developed and finalized such a plan in 2016, and prior to this implemented a formal reintegration policy in 2015. However, FDA officials have not been formally debriefing returning foreign office staff. Of the 13 former foreign office staff we interviewed, only 3 of them reported being debriefed by OIP. When asked why OIP has not debriefed with returning foreign office staff, FDA officials said that they are developing a formal exit interview process for returning staff to be implemented in fiscal year 2017. However, officials also said that the offices are still “young and evolving,” despite having been in operation for eight years. These challenges may discourage FDA officials from applying for a foreign office position and thus contribute to the foreign offices’ vacancies. Financial concerns: Our discussions with former foreign office staff also show that financial concerns with working overseas persist. For example, FDA staff posted overseas do not receive locality pay, so staff may have a reduction in their purchasing power when they are assigned to a foreign office. However, staff at certain locations may receive hardship pay, a cost of living adjustment, and other benefits. We reported on this challenge in 2010. Additionally, staff may experience an increase in pay when they move overseas and may receive a promotion while abroad, but such pay increases and promotions are considered temporary and staff must return to their original salaries and roles when they return to the United States. Some former foreign office staff said that these temporary promotions were disincentives to working overseas. When asked about this issue, FDA officials said they are considering how the agency might be able to make the promotions permanent by taking into account experience gained while working overseas. Environmental and security concerns: FDA has noted that some of FDA’s foreign offices are in countries that make recruitment difficult due to environmental concerns (such as poor air quality) or security concerns (such as dangerous locations). Although hardship pay accompanies some of these places, staff may still be hesitant to live in these locations for extended periods of time. We reported on this challenge in 2010. Personal reasons: Officials said that personal reasons affect the willingness of staff to spend time living overseas, such as whether spouses will be able to find a job abroad and concerns about the educational opportunities available for their children. Unfamiliarity with FDA’s global mission: According to FDA officials, some FDA staff do not fully understand FDA’s global mission and the importance of FDA’s presence overseas. Over the years, FDA has been transforming from a domestically focused agency operating in a globalized economy to an agency operating in a regulatory environment that functions across borders. FDA noted that some agencies, such as the Centers for Disease Control and Prevention, have a longstanding foreign presence. In contrast, FDA’s foreign posts are still relatively new, which presents a number of challenges, the agency noted. FDA officials described some of their recruitment efforts aimed at educating staff about its increasingly global mission. For example, the foreign offices have published blog postings highlighting the activities of their offices overseas and how they contribute to FDA’s mission. FDA officials also told us they have met with selected FDA staff located across the country to advocate foreign offices as career considerations. Another step FDA has taken to help reduce its vacancy rates in its foreign offices is to encourage staff to apply for a temporary duty rotation of 30-, 60-, 90-, or 120-days. In addition to helping the offices fulfill their mission, according to FDA, these rotations are a recruitment mechanism that allows staff to experience working overseas in the hope that they will eventually apply for a full-time position in a foreign office. Since 2011, 37 FDA staff have completed at least one drug-related temporary rotation in an FDA foreign office—some of these people completed more than one rotation. Of these 37 staff, 9 (24 percent) went on to work in a full-time position overseas. In addition, to address these challenges, OIP finalized its strategic workforce plan in March 2016. The plan offers a strategic and long-term view of the challenges OIP faces, and addresses the agency’s plan to recruit, hire, retain, and develop employees with the skills and abilities to fulfill the agency’s global mission, consistent with a recommendation we made in 2010. We previously recommended that FDA develop a strategic workforce plan to help ensure that the agency was able to recruit and retain staff with the experience and skills necessary for the foreign offices, and to reintegrate returning foreign office staff into FDA’s domestic offices. The plan outlines OIP’s activities, performance measures, and timeline for addressing its workforce planning challenges. The activities are categorized by specific focus areas and include, for example, developing a hiring strategy, ensuring that employees separating from the agency participate in exit surveys to determine actions for improving retention, establishing a succession plan for anticipated vacancies, and working to maximize a returning foreign office employee’s new skill set from his or her deployment. FDA’s workforce plan also addresses reintegration challenges and determining how the agency can better leverage the skills staff develop while working abroad, which reflects concerns expressed to us by former foreign office staff. For example, one activity in the workforce plan is to evaluate FDA’s new reintegration policy, which the agency issued in 2015, to determine whether it can be made more strategic and career enhancing for overseas deployment. Given that this plan has been recently developed, FDA has yet to evaluate it, but plans to do so in fiscal year 2017, and, if necessary, revise the activities or performance measures specified in the plan. We reviewed OIP’s workforce plan and identified concerns with some of the six performance measures OIP developed for the focus areas it plans to assess first. For example, the recruitment and hiring performance measure calls for OIP to reduce its vacancy rate by 5 percent—taking it from 32 percent (its vacancy rate at the conclusion of fiscal year 2015) to 27 percent at the beginning of fiscal year 2017. However, this goal is not targeted to the vacancy rates in the foreign offices. Instead, the measure targets the OIP-wide vacancy rate. As of July 2016, OIP’s domestic offices had a vacancy rate of 34 percent, in contrast to the foreign offices’ collective vacancy rate of 46 percent. Because the 5 percent reduction to OIP’s vacancy rate is a combined goal for both domestic and foreign offices, OIP could theoretically hire 8 new staff members in its domestic offices and achieve its goal without reducing any vacancies in the foreign offices. Meanwhile, the development of a concept paper on how FDA can better leverage the skills of employees returning from overseas, intended as the reintegration performance measure, is a positive step, but it does not constitute a performance measure. It may serve as a guide, but it does not measure FDA’s outcomes in this area. Some of the other performance measures identified by FDA also do not measure outcomes. For example, the implementation of a new employee orientation program may help new foreign office staff better acclimate to their new positions, but such a program does not measure outcomes in this area. A final concern with the workforce plan is that it does not take into account the recommendations of the 2016 internal evaluation of the foreign offices or the summaries of the operating states and workforce compositions of the China, Europe, India, and Latin American offices that were completed in 2014. For example, the workforce plan does not reflect the recommended foreign office staffing and position types specified in the 2016 evaluation, or address how these specifications might be achieved. We have previously reported on the importance of workforce planning, which is utilized by agencies to align their workforce with current and emerging mission and program goals, and develop long-term strategies for acquiring, developing, and retaining staff. Workforce planning helps agencies think strategically about how to put the right people with the right skills in the right places at the right time. We have previously identified key approaches for effective strategic workforce planning. These approaches may vary with each agency’s particular needs and mission, but should share certain principles, such as identifying skills and competencies to fill critical workforce gaps and the strategies needed to recruit them; developing specific strategies that are tailored to address gaps in number, deployment, and alignment of human capital; and monitoring and evaluating the agency’s progress toward its human capital goals. Similarly, federal internal control standards require agencies to establish and operate monitoring activities, evaluate results, and remediate deficiencies on a timely basis—which could be done when staff are returning from overseas deployments. Without a specific focus on reducing the number and types of foreign office vacancies, OIP may find it difficult for the foreign offices to fulfill their mission. Furthermore, by not focusing specifically on the foreign offices’ vacancies by position type FDA may be missing an opportunity to determine why particular positions are more difficult to fill than others and take appropriate action in response. The United States’ increasing dependence on global markets has been challenging for FDA. The rapid pace of globalization has complicated the agency’s efforts to ensure the safety of our drug supply. Our concerns with FDA’s response to globalization go back two decades. In that time we have made multiple recommendations to help the agency tackle this challenge. The enactment of FDASIA also provided the agency with new flexibility to help FDA cope with the growth of drug manufacturing overseas. To its credit, FDA has made important strides. It has implemented some of our 2008 and 2010 recommendations and is taking steps to address others. FDASIA has further enhanced the agency’s efforts. To date, FDA has increased the number of foreign drug inspections, improved information on foreign establishments manufacturing drugs for the U.S. market, and opened offices overseas. While FDA has made progress on some fronts, it has been incremental on others. FDA is now using a single risk-based model to select domestic and foreign establishments to inspect so that those that pose the greatest risk are prioritized for inspection, but the agency still lacks inspection history on approximately 33 percent of foreign establishments. While FDA has a plan to fill this knowledge gap over the next few years, this is an issue it has been aware of since at least 1988. Given the longevity of this issue, it will be important for the agency to fully execute its plan to inspect those remaining establishments for which it has no inspection history over the next three years. FDA has also made progress in its strategic planning for the foreign offices, but despite these efforts, the agency has yet to determine whether the foreign offices meaningfully contribute to drug safety, because FDA has no formal process for assessing the offices’ contributions. In 2008, the agency determined that opening foreign offices was an instrumental part of its response to globalization. Our recommendation that FDA develop performance goals and measures for these offices followed in 2010, two years after the first office was opened. We believe this recommendation has not been fully implemented. The two performance measures currently used to assess the foreign offices do not fully capture the specific contributions these offices have made. While FDA officials shared examples of the foreign offices’ accomplishments, they do not systematically track such information, nor have they fully assessed the extent to which the offices are helping to ensure drug safety. We believe it is important for FDA to track these types of results-oriented outcomes, and for the agency to determine how their performance measures—whether the existing ones or those currently being tested—can be used to demonstrate such results. Having performance measures that demonstrate results-oriented outcomes will better enable FDA to meaningfully assess the foreign offices’ contributions to ensuring drug safety. FDA should also consider including an examination of the appropriate staffing levels for its current foreign offices in its assessment of them. FDA’s internal evaluation proposed a process for determining the correct mix of staffing and position types for the foreign offices, but as OIP has yet to implement and apply the process to the foreign offices, such an examination has not yet been completed. While the agency’s progress overseas may be aggravated by the difficulties it faces in decreasing their vacancy rates, the agency must determine what outcomes it is working to achieve through these offices and then consider the appropriate staffing to reach those goals. Regardless, the current overall foreign office vacancy rate of 46 percent could easily undermine even the best strategic plan and precludes the offices from being as effective as possible. As we also recommended in 2010, FDA has now completed a strategic workforce plan for the foreign offices to help ensure that the agency is able to recruit and retain staff with the necessary experience. We recognize the value of the completion of this plan. However, FDA has not fully addressed our recommendation, because some of the reasons for the high vacancy rates in the foreign offices are not addressed. While FDA may not be able to address some of these reasons, such as time to deployment, it is all the more important that it addresses those within its span of control, such as addressing the financial concerns raised by staff and discussed in our 2010 report, as doing so may contribute to a decrease in its foreign office vacancy rate. It is also imperative that FDA fully implement its new reintegration program as outlined in the plan. The difficulties staff have experienced upon their return to domestic positions is one that former foreign office staff repeatedly shared with us when we prepared this and our 2010 reports. While the workforce plan contains goals and measures, the plan circumvents the high foreign office vacancy rate, rather than directly tackling it, by targeting a 5 percent reduction in OIP vacancies overall, rather than applying this goal exclusively to the foreign offices. The plan also does not target vacancies by specific position types. In essence, the current goal targeting OIP vacancies overall obscures the underlying challenges the agency faces of staffing people overseas and for particular positions. Without targeting the foreign offices specifically or the types of positions most likely to have vacancies, FDA will not have a meaningful measure reflecting its true staffing position overseas. FDA’s response has been, in part, that the offices are still new and evolving, and it is too soon to expect more than it has already accomplished. We believe sufficient time has elapsed for the agency to address its remaining challenges. Otherwise, given their significance, FDA may not know the extent to which its foreign offices are actually assisting the agency it in its efforts to ensure drug safety. To help ensure that FDA’s foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, we recommend that the Commissioner of FDA take the following two actions as the agency continues to test performance measures and evaluate its OIP strategic workforce plan: 1. Assess the effectiveness of the foreign offices’ contributions by systematically tracking information to measure whether the offices’ activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters. 2. Establish goals to achieve the appropriate staffing level for its foreign offices, which would include separating foreign office vacancies from the OIP-wide vacancy rate, and setting goals by position type. We provided a draft of this report to HHS for comment. In its written comments, reproduced in appendix V, HHS concurred with our two recommendations and said it is taking immediate steps to address them. For example, starting in fiscal year 2017, FDA plans to conduct internal reviews of its foreign offices’ performances annually, review the offices’ programs and efforts at the activity level, and review performance indicators. To accomplish this, HHS said that OIP has recently hired two designated full-time employees to work on strategic planning, operational plans, and performance measures. HHS also said that OIP plans to, among other things, adjust its performance measures to track the foreign offices’ measures separately from its domestic offices, and characterize the offices’ contributions by type of commodity, including drugs. Additionally, HHS said that OIP’s strategic workforce plan will be updated to reflect the disaggregation of performance measures that track foreign office vacancy rates and targets by position type. Furthermore, FDA said it is developing recruitment, hiring, retention, and reintegration strategies to enable the agency to utilize the unique experiences that foreign office employees develop overseas. HHS also provided technical comments, which we incorporated as appropriate. As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the Secretary of Health and Human Services and the appropriate congressional committees. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix VI. The Food and Drug Administration’s (FDA) foreign offices have helped ensure drug safety by collaborating with foreign counterparts in their host countries. According to FDA officials, each foreign office had examples of collaborative activities with their respective foreign counterparts that may have increased drug safety. For example, FDA’s China and India offices both conducted workshops on the importance of data integrity for industry representatives and foreign regulators, while the Latin America office sponsored a training session for Mexican regulators on current good manufacturing practices and inspections. See table 7 for examples of activities from each foreign office provided by FDA officials that may have helped ensure the safety of drugs entering the United States. In addition to the contact named above, Geri Redican-Bigott (Assistant Director), Kaitlin Coffey (Analyst in Charge), Nick Bartine, George Bogart, Zhi Boon, Muriel Brown, Drew Long, and Michael Rose made key contributions to this report. High-Risk Series: An Update. GAO-15-290. Washington, D.C.: February 2015. High-Risk Series: An Update. GAO-13-283. Washington, D.C.: February 2013. High-Risk Series: An Update. GAO-11-278. Washington, D.C.: February 2011. High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January 2009. Food Safety: Additional Actions Needed to Help FDA’s Foreign Offices Ensure Safety of Imported Food. GAO-15-183. Washington, D.C.: January 30, 2015. 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. Washington, D.C.: September 30, 2010. Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-term Planning Is Needed. GAO-10-960. Washington, D.C.: September 30, 2010. Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA’s Foreign Drug Inspection Program. GAO-08-970. Washington, D.C.: September 22, 2008. Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program. GAO-08-701T. Washington, D.C.: April 22, 2008. Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s Program for Inspecting Foreign Drug Manufacturers. GAO-08-224T. Washington, D.C.: November 1, 2007. Human Capital: Key Principles for Effective Strategic Workforce Planning, GAO-04-39. Washington, D.C.: December 11, 2003. Food and Drug Administration: Improvements Needed in the Foreign Drug Inspection Program. GAO/HEHS-98-21. Washington, D.C.: March 17, 1998.

Summary: Globalization has complicated FDA's oversight of drugs marketed in the United States. FDA reports that more than 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients are produced overseas. FDA inspects drug manufacturing establishments to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices. Beginning in 2008, FDA established foreign offices to obtain better information on products coming from overseas and perform inspections, among other things. In 2008 and 2010, GAO examined FDA's foreign drug inspection program and recommended it conduct more foreign inspections. In another 2010 report, GAO recommended the agency develop strategic and workforce plans for its foreign offices. GAO was asked to update its work with a focus on FDA's oversight of foreign drug establishments. This study examines (1) enhancements FDA has made to its foreign drug inspection program; and (2) FDA's assessment of its foreign offices, and the challenges they face in ensuring drug safety. GAO analyzed FDA's inspection data from fiscal year 2007 through June 30, 2016; reviewed agency planning documents; and interviewed FDA officials, including former foreign office employees. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection. The number of foreign inspections has consistently increased each year since fiscal year 2009. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspections. FDA has also improved the accuracy and completeness of information on its catalog of drug establishments subject to inspection. It has also reduced its catalog of drug establishments with no inspection history to 33 percent of foreign establishments, compared to 64 percent in 2010. However, the number of such establishments remains large, at almost 1,000 of the approximately 3,000 foreign establishments. FDA plans to inspect all of these establishments over the next 3 years. FDA has not yet assessed its foreign offices' contributions to drug safety. FDA has made progress in its strategic planning for its offices in China, Europe, India, and Latin America, but the lack of an assessment is inconsistent with federal standards for internal controls. Though FDA uses two performance measures to assess the foreign offices—number of medical product inspections and number of collaborative actions—the collaborative action measure does not capture the offices' unique contributions to drug safety. Moreover, the foreign offices face persistently high vacancy rates. As of July 2016, 46 percent of the foreign offices' authorized positions were vacant. Although FDA recently finalized a workforce plan, GAO identified several weaknesses with it. For example, the plan sets a workforce target that applies to both foreign and domestic international program offices, making it difficult to ascertain whether its goal of reducing foreign office staff vacancies is being met. GAO recommends that FDA assess the contributions of the foreign offices, and set a goal that distinguishes between the vacancy rates of staff in its foreign offices and those in its domestic international program office. HHS agreed with GAO's recommendations.