SEATTLE _ In late April 2009, Dr. Joshua Sharfstein, then the Food and Drug Administration's principal deputy commissioner, received an urgent weekend phone call from the director of the Centers for Disease Control and Prevention.
Dr. Rich Besser told Sharfstein that the CDC _ and by, extension, public health departments nationwide _ faced a serious problem.
Less than two weeks earlier, the CDC had identified a virulent new strain of swine flu in a 10-year-old patient in California. Within days, the novel strain cropped up in another California child, two patients in Texas, a cluster in Mexico and an outbreak at a New York high school. Dubbed H1N1, the virus was spreading fast, with all signs pointing toward a pandemic.
Widespread diagnostic testing was needed immediately to understand the scope of the nation's outbreak, Sharfstein recalled Besser telling him. But there was one big catch.
"He said the test was going to take at least six months to review, but we couldn't wait that long," Sharfstein, now a vice dean of public health at Johns Hopkins University, told The Seattle Times.
Within 48 hours, Sharfstein and a team of FDA lawyers found a way to get tests out quickly through an existing FDA process called "Emergency Use Authorization." The novel use of the "EUA," a process typically aimed to give the FDA some oversight over unapproved medical devices needed for emergencies, marked the first time it was tapped for a public health diagnostic test.
That regulatory innovation, which allowed the swine flu test to bypass typical FDA trials that can take more than a year, has since served as a national model for pandemics, including responses to Ebola, Zika and other emerging viruses.
But past successes with the emergency authorization process also set the stage for what would be its biggest failure: Quickly getting reliable diagnostic tests for the novel coronavirus into labs nationwide last month, before the fast-spreading infection that had savaged countries around the world could do so in the U.S.
With the CDC always serving as the emergency authorization applicant and test distributor on behalf of scores of domestic public health labs, a key weakness was overlooked: If something went wrong with the CDC's tests, the labs that relied on them would be rendered helpless and without immediate testing alternatives.
"We had only needed to use the EUA process a few times before, and it really had worked," said Scott Becker, executive director of the Association of Public Health Laboratories, which represents 120 public health labs nationwide. "But in all the previous responses, we've never had the test fail right out of the gate."
Many public health labs, after receiving the first batch of CDC diagnostic panels in early February, started reporting problems with validating test results. The labs were hamstrung while they waited for the CDC to fix the problem.
The process took nearly three weeks, a lag time during which labs couldn't try other testing options that hadn't won the FDA's clearance. Meantime, commercial labs without emergency authorizations were sidelined.
"We didn't see a benefit for individual labs going through that (EUA) process because the CDC always had them covered," Becker said. "I do think in the future, we're going to look very carefully at having multiple tests available to us because we don't want to be where we were, which was a single point of failure."
The testing shortage hurt initial efforts to track and contain coronavirus outbreaks in Washington and other states, public health officials have acknowledged.
The CDC, in a statement this week, said: "This process has not gone as smoothly as we would have liked, but there is currently no backlog for testing at CDC and since Friday, February 28, 2020, more and more state labs are coming online."
But once the nation fell behind in testing, the problems have only persisted. A rapid scale-up of testing capacity to catch up to the coronavirus has strained health care systems and depleted stockpiles of lab materials. People across the nation, including seriously ill patients, high-risk nursing home residents, even medical professionals exposed to the sick, continue to complain they can't get tested.
Some experts now say the authorization process that worked when responding to past pandemics became a bottleneck of restrictions for coronavirus testing, when it didn't need to be.
The FDA disputes that.
"Laboratories always have had the ability to develop tests from day one," FDA spokeswoman Stephanie Caccomo said in an email late Wednesday, adding the agency has worked with manufacturers and labs since January.
"We have encountered examples where labs did not understand the FDA process and mistakenly believed there was more work involved, or just did not even realize that they could develop a test in the first place," she added.
