Types of Drug Inspections

FDA conducts several types of inspections of drug manufacturing  establishments to protect the drug supply. 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. FDA Has Increased Its Foreign Drug Inspections and Enhanced Its Ability to Prioritize Drug Establishments for Inspection

Since fiscal year 2009, FDA has increased the number of all foreign drug  inspections conducted each year. Beginning in  fiscal year 2015, FDA conducted more foreign than domestic inspections. FDA Has Improved Information on Its Catalog of Foreign Drug Establishments, but Lacks Inspection History on One- Third of Them

Since 2010, FDA has taken steps to improve the accuracy and  completeness of its catalog of foreign drug establishments. 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. 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. This is also consistent with a  recommendation we made to the agency in 2008. FDA Has Not Yet Assessed Its Foreign Offices’ Contributions to Drug Safety, and Their Efforts are Impeded by High Vacancy Rates

FDA has begun to take steps to enhance the agency’s strategic planning  for the foreign offices and has developed two performance measures. 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. FDA reported exceeding its goal of 25 collaborative  actions in fiscal year 2015 by 2, for a total of 27 collaborative actions. According to FDA officials, this  measure applies to all of OIP’s offices—both foreign and domestic. 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. 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. Appendix I: Types of Foreign Drug Establishment Inspections Conducted, Fiscal Year 2010 through June 30, 2016

Appendix II: Drug Establishments that the Food and Drug Administration May Never Have Inspected

Appendix III: Number of Foreign Drug Inspections in which Temporary Duty Staff Participated

Appendix IV: Efforts by the Food and Drug Administration’s Foreign Offices to Enhance Drug Safety

The Food and Drug Administration’s (FDA) foreign offices have helped  ensure drug safety by collaborating with foreign counterparts in their host  countries.
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.

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.
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.

What GAO Recommends

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.