FDA’s emergency use authorization process for monkeypox tests is more streamlined than it was for COVID-19 test EUAs in the early days of the coronavirus pandemic, experts say, but at the same time the agency has lagged behind on developing and disseminating guidance about the EUA process to monkeypox test developers.
Joel White, executive director of the Health Innovation Alliance, acknowledges the agency has put out clearer guidance for monkeypox test developers, but maintains the agency has moved much slower than it did with COVID-19, lagging behind on drafting and releasing guidance.
“The thing that’s baffling to me is that we went through this COVID thing, and we wanted to scale up rapidly to have 340 million tests available very quickly — we’re talking about 80,000 tests for monkeypox,” White said. “The population is different, obviously, but it’s almost like we didn’t learn anything from COVID.”