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Drug Safety: FDA Should Take Additional Steps to Improve Its Foreign Inspection Program

GAO-22-103611 Published: Jan 07, 2022. Publicly Released: Feb 07, 2022.
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Fast Facts

The Food and Drug Administration inspects foreign and domestic drug manufacturers to ensure drug safety and effectiveness. More than 50% of manufacturers supplying the U.S. market are located overseas—many in India and China.

The pandemic postponed almost all foreign inspections for most of 2020. But the number of these inspections had generally been declining since FY 2016—which FDA attributes in part to fewer investigators.

We recommended that FDA, among other things, develop tailored strategies and time frames to recruit and retain investigators for its foreign inspection workforce, which could help address a backlog of inspections.

The 10 countries with the most foreign drug establishments manufacturing drugs for the U.S. market as of June 2021

color-coded map showing the number of manufacturing establishments in other countries

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Highlights

What GAO Found

In fiscal year 2019, the Food and Drug Administration (FDA) began to increase the number of inspections of foreign drug manufacturing establishments after decreases from fiscal years 2016 through 2018. FDA, an agency within the Department of Health and Human Services (HHS), conducts the largest number of foreign inspections in India and China, where more than one-third of foreign establishments supplying the U.S. market are located. However, beginning in March 2020, FDA postponed most inspections because of the COVID-19 pandemic, conducting three foreign inspections from March to October 1, 2020. In comparison, FDA conducted more than 600 foreign inspections over the same time period in each of the 2 prior years. From October 2020 to April 2021 (the most recent period for which data are available), FDA conducted 18 high priority foreign inspections—primarily in China. In November 2021, FDA announced it was developing plans to potentially resume foreign inspections in February 2022.

GAO has reported that FDA faces unique challenges conducting foreign inspections—including that inspections have generally been preannounced and that investigators may rely on the establishment being inspected to provide translation services. While drugs manufactured overseas for the U.S. market must meet the same requirements as those manufactured in the U.S., these unique challenges raise questions about the equivalence of foreign to domestic inspections. FDA plans on implementing pilot programs focused on evaluating the effect of conducting unannounced inspections and using independent translation services. However, these efforts have been delayed by the COVID-19 pandemic and the agency has not yet finalized the pilots' designs.

As FDA moves forward, the agency could benefit from incorporating leading practices for designing a well-developed and documented pilot program—such as developing a methodology that details the information necessary to evaluate the pilot. This would help ensure the pilots provide FDA with the information it needs to assess the value of unannounced inspections and independent translation services, and to decide whether these approaches should be applied more broadly to other foreign inspections.

While FDA has reduced vacancies among its general drug inspection workforce, FDA data showed that the agency still has persistent vacancies among those who specialize in foreign inspections as of November 2021. Specifically:

  • eight of 20 positions were vacant in FDA's cadre of drug investigators that conduct only foreign inspections, and
  • five of 15 drug investigator positions were vacant in its foreign offices located in China and India.

These are longstanding challenges that GAO has previously identified. According to FDA officials, foreign inspection work is challenging, requiring the investigator to work independently in a foreign establishment under constrained time frames. In 2020 and 2021, FDA began to take steps to identify new strategies to recruit and retain this workforce, but the agency has not yet detailed implementation steps and time frames. Fully developing such tailored strategies could help ensure FDA has the workforce needed to meet its global mission.

Why GAO Did This Study

FDA is responsible for ensuring the safety and effectiveness of all drugs marketed in the U.S., regardless of where they are produced. Globalization—and the outbreak of COVID-19—have complicated FDA's oversight of the more than 4,000 establishments manufacturing drugs for the U.S. HHS reported that 73 percent of establishments manufacturing active ingredients, and 52 percent of those manufacturing finished drugs for the U.S., were located overseas as of March 2021.

GAO's concerns about FDA's ability to oversee the increasingly global drug supply chain led it to designate the issue as a high risk area in 2009. GAO was asked to update its work on FDA's foreign drug inspection program. This report (1) describes the number of inspections prior to and during the COVID-19 pandemic, (2) examines steps taken to address challenges related to preannouncing foreign inspections and language barriers, and (3) examines efforts to maintain a sufficient inspection workforce, among other objectives. For this work, GAO examined FDA data and documents and interviewed drug investigators and other FDA officials. GAO also visited FDA foreign offices in China and India in fall 2019.

Recommendations

GAO is making three recommendations: that FDA incorporate leading practices into the design of both its unannounced inspection and translation pilot programs and fully develop tailored strategies to ensure it has a sufficient foreign inspection workforce. HHS agreed with GAO's recommendations.

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should ensure that the agency incorporates leading practices we identified for designing a well-developed and documented pilot program as it finalizes its plans for implementing a pilot program to evaluate the effectiveness and efficiency of unannounced foreign inspections. (Recommendation 1)
Open – Partially Addressed
HHS concurred with this recommendation. In a July 2022 response, FDA officials described steps the agency had taken to incorporate leading practices into the design and documentation of its unannounced foreign inspection pilot program. Specifically, officials told us they had developed a pilot plan with clear and measurable objectives; created a thorough assessment methodology based on a literature review; created multiple evaluative resources to analyze pilot implementation; put processes in place to allow FDA to assess pilot scalability; and engaged stakeholders through monthly briefings with eight FDA offices. In a June 2023 response, FDA officials reported that the first phase of this pilot, which focused on unannounced inspections, was launched in India in March 2022 and completed in December 2022. In Fall 2023, FDA provided the assessment methodology for the pilot as a whole, as well as an evaluation of Phase I of the pilot. At that time, FDA officials told us that the first phase of the pilot had commenced in China and that they hoped to initiate the second phase of the pilot (primarily focused on pre-announced inspections to serve as a control group) in India in Spring 2024. To fully implement this recommendation, FDA needs to provide additional supporting documentation outlining how FDA has incorporated the remaining leading practices into the design of its pilot, including the establishment of measurable objectives and stakeholder communication efforts. Doing so could help ensure FDA is collecting the information it needs to evaluate the pilot program and ensure agency time and resources are being used effectively.
Food and Drug Administration The Commissioner of FDA should ensure that the agency incorporates leading practices we identified for designing a well-developed and documented pilot program as it finalizes its plans for implementing a pilot program to evaluate the costs and effects of using different types of translation services during foreign inspections. (Recommendation 2)
Open
HHS concurred with this recommendation. In a July 2022 response, FDA officials said the agency had initiated steps to conduct this pilot program to evaluate using different types of translation services during foreign inspections. For example, officials said FDA had assigned a project manager to assist in the development of goals and metrics in alignment with leading practices for designing pilot programs. Officials said the agency was also establishing a project team and reviewing data points to facilitate the development of an overall project framework. To fully implement this recommendation, FDA needs to provide documentation of the pilot program's: objectives; assessment methodology; evaluation strategy; assessment of scalability; and communications with stakeholders in order to allow GAO to assess the extent to which the actions FDA described in its July 2022 response address the recommendation. Implementing this recommendation could help ensure FDA is collecting the information it needs to evaluate the pilot program and ensure agency time and resources are being used effectively.
Food and Drug Administration The Commissioner of FDA should ensure the agency fully develops tailored strategies—including detailing implementation steps and time frames—focused on recruiting new and developing and retaining current investigators to specialize in conducting foreign drug inspections. (Recommendation 3)
Open
HHS concurred with this recommendation. In July 2022 and January and March 2023 responses FDA officials described six tailored strategies the agency had developed focused on recruitment, development, and retention of drug investigators who perform inspections overseas, which were developed by the newly formed GAO Recruitment and Retention Action Plan Work Group. First, FDA officials said they continued to use alternative hiring authorities and compensation methods to recruit new and retain current investigators specializing in foreign drug inspections. Second, FDA officials said they undertook a number of specialized recruitment efforts. For example, FDA officials said they recruited four bilingual drug investigators (two Hindi/English and two Mandarin/English speakers) for which language testing was underway as of March 2023. Third, FDA officials described a number of changes to investigator training, including standardizing the process for new investigators to travel internationally with seasoned investigators. Fourth, FDA officials described a number of efforts to maximize retention incentives, such as increasing the cash incentive investigators receive for the completion of each 3-week foreign trip. Fifth, FDA officials described travel process improvements, such as the development of a training on foreign travel processes that was launched in June 2022. Finally, FDA officials provided updates on two proposals we had described in our January 2022 report as being in the early stages: offering 6-month details to the foreign drug cadre and developing a career pathway for newly hired investigators to directly convert to one of the foreign drug inspection specialist groups after initial training. As of March 2023, five drug investigators had been selected for 6-month details to the cadre and two drug investigators had been selected for 4-month details, according to FDA officials. In terms of the career pathway, officials told us that a concept paper for this pathway was developed, and the proposal was presented to FDA leadership in June 2022. To fully implement this recommendation, FDA needs to provide documentation of the six tailored strategies and their implementation timelines in order to allow GAO to assess the extent to which the actions FDA described in its July 2022 and January and March 2023 responses address the recommendation. By implementing this recommendation FDA would be better able to ensure that it is recruiting investigators with an interest in foreign work and providing a pathway to cultivate its current investigators to gain the skills necessary to join the foreign cadre or foreign offices.

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Topics

Active pharmaceutical ingredientCompliance oversightDrug safetyDrugsForeign drug inspectionGeneric drugsHealth careManufacturingpandemicsPrescription drugs