(Originally published Feb. 6, 2020.)
As the world grapples to contain a troubling new strain of the coronavirus, an early criticism of the U.S. response has come from an influential critic: Dr. Scott Gottlieb, the former head of the Food and Drug Administration.
Gottlieb is alarmed that this country’s capacity to test for the pathogen is lagging as the outbreak spreads from China to 27 other countries. It is imperative that Congress and the Trump administration act on his concerns to ensure the nation has the readiness and resources to contain this new public health threat.
In a long Twitter thread posted Sunday, Gottlieb said swifter, broader screening is needed nationally to detect coronavirus, which has sickened more than 28,000 people in China. The “Catch 22,” as Gottlieb called it, is that so far, only the U.S. Centers for Disease Control (CDC) has been able to run the tests for this virus, creating a bottleneck. For testing to occur elsewhere, leaders of two key federal agencies must sign off to allow the CDC to share technology.
There’s generally a two-part process during outbreaks. The U.S. Department of Health and Human Services first has to determine whether there’s a public health emergency or “significant potential” for one. Once that decision is made, the U.S. Food and Drug Administration (FDA) can issue an emergency authorization allowing testing beyond the CDC. The Department of Health and Human Services finally declared the public health emergency on Jan. 31 — a full month after the outbreak was reported in Wuhan, China.
To their credit, the FDA and the CDC were ready to go. The FDA issued its emergency use authorization on Tuesday. On Thursday, the CDC announced it had begun shipping test kits to “qualified U.S. and international laboratories.” The CDC had also taken previous steps to share information to help commercial firms develop tests. That could expand testing more broadly, potentially allowing hospitals to run them. Clearly, these two agencies grasped the urgency. Gottlieb commended their preparation on Thursday, but he has also raised concerns about removing additional bureaucratic hurdles that could prevent testing at hospitals.
Minnesotans will be glad to know that the state’s world-class health department is expected to be an early recipient of a CDC test kit. The state has not had any confirmed cases of coronavirus. So far, the CDC reports that 12 cases have been reported in six states: Washington, California, Arizona, Illinois, Massachusetts and, most recently, Wisconsin.
An official with the Association of Public Health Laboratories said expanding testing capabilities sooner is always better during an outbreak. The organization’s members had been “anxiously awaiting the declaration, which allows the deployment of test kits” under the FDA’s emergency authorization, said Kelly Wroblewski, the association’s director of infectious disease programs.
Questions are merited about how long it took HHS to set the process in motion. During a previous outbreak of another coronavirus, one called MERS, HHS had made this critical declaration before a case occurred in the U.S. The agency can act when there’s a significant potential for a public health crisis. The agency would not provide an answer when an editorial writer asked why it still took a month for it to act.
On Thursday, an HHS spokesman noted that it took MERS much longer to reach the U.S. than the new coronavirus, “so we had plenty of time to develop a test before the virus got here.” The spokesman referred other questions to the Centers for Medicare and Medicaid Services, headed by Seema Verma, who has been dogged by questions about using taxpayer dollars to hire image consultants.
Tensions between Verma and HHS Sec. Alex Azar have repeatedly made headlines, raising serious questions about how well the agency is running. Verma’s communications staff did not respond to an editorial’s writer’s questions about the declaration’s timing, but transparency is imperative as the outbreak continues. Congress should follow up.