Federal officials botched plans to prepare the U.S. for an outbreak of the novel coronavirus, and they even misled state public health authorities on the effectiveness of a diagnostic test for SARS-CoV-2, according to a March 27 article in USA Today.
The article claims that officials with the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) "bungled" the effort to develop the first diagnostic tests for SARS-CoV-2 and left local authorities "shackled" as the virus spread around the country.
The newspaper based its story on interviews with scientists, public health authorities, and community leaders. It concluded that with their actions, the CDC and FDA "shirked their responsibility to protect Americans in an emergency like this new coronavirus."
The article claims that the CDC misled local authorities when it stated in a conference call in late February that state labs would be able to send samples to the CDC and receive results in 24 hours. Instead, it took four to five days for results to be returned to labs in the field.
The article also criticized the FDA for putting in place emergency restrictions on diagnostic tests for SARS-CoV-2 that would not have been in place during normal circumstances. And labs with laboratory-developed tests for the novel coronavirus were required to submit applications with 28 pages of documentation to receive emergency use authorization.
The FDA stuck with the "most restrictive approaches possible" with respect to regulation of diagnostic tests for SARS-CoV-2, according to a former FDA official quoted in the story. The agency didn't relax its approach until February 29.
For its part, the CDC shipped tests that initially were flawed and didn't work due to problems with the reagent used in the kits, according to the story.
The article concluded that the actions of both agencies resulted in "lost weeks" in February that could have been spent preparing for the spread of SARS-CoV-2 in the U.S.
