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Review of the Food and Drug Administration's Foreign Drug Inspection Process

The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States. However, FDA's oversight of the nation's drug supply chain has become increasingly complicated because many drugs used in the U.S. are manufactured overseas. FDA estimates that nearly 40 percent of finished drugs and approximately 80 percent of active pharmaceutical ingredients are manufactured in registered establishments in more than 150 countries. To ensure that drugs are manufactured in compliance with current good manufacturing practice regulations, FDA conducts inspections of foreign facilities that manufacture drugs for the U.S. market. At the end of an inspection, observations are made and a determination of whether any condition or practice violates Federal requirements. FDA may take additional actions to ensure that the violations are corrected. In May 2017, FDA began implementing major programmatic changes to enhance its ability to protect public health. FDA's major programmatic changes included a structural realignment of its Office of Regulatory Affairs (ORA) and an agreement between FDA's Center for Drug Evaluation and Research and ORA that aligns and coordinates FDA's field professionals who conduct inspections and its review staff who evaluate drug products. Recently, Congress raised concerns about the safety of certain drugs manufactured overseas and the challenges that FDA faces with its foreign drug inspection process. Our review will determine whether recent programmatic changes have improved FDA's foreign drug inspection process.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
June 2019 Food and Drug Administration Review of the Food and Drug Administration's Foreign Drug Inspection Process Office of Audit Services W-00-19-50000 2020