Dive Brief:
- FDA is postponing inspections of overseas manufacturing plants and facilities supplying regulated medical products 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, FDA said in a Tuesday statement, acknowledging the action "may impact other FDA responsibilities, including product application reviews."
- For now, most inspections will be postponed through April, although the agency said it will resume inspections “as soon as feasible.”
Dive Insight:
In place of inspecting overseas facilities, FDA will rely on border inspections, records requests, information exchange with international governments and, if needed, import restrictions to ensure product 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.
Product reviews 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 Commissioner Stephen Hahn said.
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 more than 100 countries, with the biggest impact so far in China, where the virus has infected more than 80,000 people, according to the World Health Organization.
