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2 years ago-Biopharma Group

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

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The Food and Drug Administration is postponing inspections of overseas manufacturing plants and facilities supplying drugs to the U.S. except for those deemed “mission critical.” The decision was based on travel restrictions and advisories put in place by the federal government in response to the global spread of the new coronavirus.”Alternative tools and methods” will be used to maintain oversight of foreign manufacturers and products, the FDA said in Tuesday statement. The regulator acknowledged the move could affect its reviews of experimental drugs, however. For now, inspections will be postponed through April, though the FDA says it will resume inspections “as soon as feasible.”

In place of inspecting overseas facilities, the FDA will rely on border inspections, records requests, information exchange with international governments and, if needed, import restrictions to ensure drug safety.

The agency has already been using these methods to oversee goods imported from China following a decision to postpone inspections in that country last month. “Mission critical” inspections may still continue, but will be evaluated on a case-by-case basis.

The decision came after FDA leaders reviewed State Department travel advisories, Centers for Disease Control and Prevention recommendations, guidelines from the Office of Personnel Management and restrictions on entry imposed by foreign governments.

Reviews of experimental drugs could be delayed if overseas facilities can’t be inspected, the agency said. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government,” a statement from FDA head Stephen Hahn said.

The FDA inspected 110 overseas facilities manufacturing human drugs in the 12 months ended September 2019.

Pausing inspections could raise further questions about the security of the global drug supply chain. The agency 12 days ago reported its first drug shortage related to outbreak, and there are concerns that supplies of pharmaceutical ingredients manufactured in China could run short thanks to the massive quarantining and social distancing measures taken there.

The virus, SARS-CoV-2, causes a respiratory illness called COVID-19. As of late March 10, there were more than 110,000 confirmed cases and over 4,000 deaths across 100 countries, with the biggest impact so far in China, where the virus has infected nearly 81,000 people, according to the World Health Organization.

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