Drug Safety: FDA Has Improved Its Foreign Drug Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its Foreign Offices
Fast Facts
Much of the U.S. drug supply is manufactured overseas. FDA inspects drug manufacturing facilities around the world to ensure that their drugs are safe for the U.S. market.
FDA uses a risk-based approach to select which manufacturing establishments to inspect—prioritizing those that make drugs which, if defective, pose the greatest public health risk.
In part to help its inspection efforts, FDA opened offices in China, India, Europe, and Latin America. Yet FDA has not assessed these offices' contributions to drug safety, and nearly half of their authorized positions are unfilled. We made recommendations on how FDA could improve in these areas.
Total Number of FDA Inspections of Domestic and Foreign Drug Establishments, Fiscal Year 2007 through June 30, 2016
Bar chart showing increase in number of FDA foreign drug establishment inspections.
Highlights
What GAO Found
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.
Total Number of Food and Drug Administration (FDA) Inspections of Domestic and Foreign Drug Establishments, Fiscal Year 2007 through June 30, 2016
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.
Why GAO Did This Study
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.
Recommendations
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.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration |
Priority Rec.
To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should 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. |
In a June 2022 written response, FDA described multiple strategic planning efforts it was undertaking to assess the effectiveness of its overseas offices and to track activities that specifically contribute to drug safety outcomes. Of these, FDA provided supporting documentation that it has developed performance measures related to inspections conducted by overseas office staff, which it implemented as of March 2023. Specifically, these measures included targets and assessed the contribution of the overseas offices toward helping FDA follow up on prior inspections that identified deficiencies. FDA indicated that the Office of Global Policy and Strategy (OGPS, formerly the Office of International Programs) selected these performance measures in collaboration with ORA to ensure they are in accordance with ORA's existing performance measures. In addition, FDA described efforts to track outcomes unrelated to inspection activities, which it noted were inherently difficult to measure. Specifically, FDA described the development of focal areas of work, such as drug safety. Within each area, the office developed indicators and measures toward long-term goals, and noted that the effort was a collaboration between OGPS and the subject matter experts in the product centers. FDA also described its plans to track these measures each year and consider the need for revisions. In a June 2023 written response, FDA indicated that OGPS's strategic plan expanded to include several "focal areas" of work: drug safety, food safety, good regulatory practices, and medical devices. Within each focal area, the office had identified "desired future states," which are long-term desired goals. In October 2023, FDA provided drafts of these focal areas that included proposed measures, which indicated that they still needed to be discussed with the centers to ensure alignment. As of February 2024, FDA indicated that this work was continuing. In May 2024, FDA indicated in a written response that the final measures are expected to be completed by end of fiscal year 2024. While the development of these measures is a positive step, GAO will leave this recommendation open until FDA fully aligns these measures with the centers and finalizes them.
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| Food and Drug Administration | To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its OIP strategic workforce plan, the Commissioner of FDA should 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. |
In June and July 2018 FDA described its recent efforts to achieve the appropriate staffing level for its foreign offices. FDA reported it has separated foreign office vacancies from the OIP-wide vacancy rate and also set staffing goals by position type, as we recommended. FDA has also developed and implemented a strategic workforce plan to improve strategies for the recruitment, retention, and reintegration of staff; instituted pay incentives to retain foreign office staff as well as locality pay for those deployed overseas; tracked average deployment times; created two recruitment videos; and temporarily assigned staff to short-term rotations in the foreign offices. It is also notable that the vacancy rate in FDA's foreign offices has declined substantially from an overall rate of 46 percent in July 2016 to 15 percent in July 2018.
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