Covid-19 Hurts FDA Foreign Drug Inspections: GAO

Government Accountability Office (GAO) healthcare director Mary Denigan Maculey says that the outbreak of Covid-19 has added “a level of complexity” to an already strained FDA system for inspecting drug manufacturers in foreign countries. Testifying before the Senate Finance Committee, Denigan-Maculey said that over the years since the GAO first examined the issue, “FDA has made significant changes to adapt to the globalization of the pharmaceutical supply chain and has greatly increased the number of inspections it conducts of foreign establishments.”

Still, she said, GAO found in 12/2019 that the agency faced many of the same challenges overseeing foreign establishments that GAO identified over the last two decades. “These included inspector vacancies and unique challenges when inspecting foreign drug establishments that raised questions about the equivalence of those inspections to domestic inspections,” she said.