The FDA's Perpetual Process Machine
It might be time to review the massive damage that the FDA is doing by restricting the supply and use of tests for the SARS-CoV-2 virus.
Massive? With enough tests, the US could have avoided the enormous cost that this virus is imposing – at least 200,000 excess deaths and $8 trillion in lost output.
Here I’ll provide a recap with links about how the FDA responded to just a couple of issues since the start of the pandemic.
Approving a Virus Test That Worked
Many accounts have noted how the failure of the virus test developed by the CDC delayed the US response to the virus. The fact that has not gotten as much attention is that although the FDA promptly approved the broken test from the CDC, it took an excruciatingly long time to approve tests that actually worked.
On February 4, the FDA promptly approved the test that the CDC developed. Within hours of receiving it on February 8, a laboratory in New York discovered that it did not work. (Washington Post)
After private laboratories developed their own tests, they struggle with the process of getting them approved. “The Mayo Clinic created its first-ever rapid response team. A third of the 15 members were devoted solely to the FDA’s data and paperwork demands. Like others on the team, they worked 15-hour days for three weeks.” (Washington Post)
Alex Greninger and his colleagues at the University of Washington “spent almost a hundred hours filling out a baroque, thirty-page form, filing the authorization request on February 19th. Still no dice: he had e-mailed the material, and the F.D.A. insisted that he print it out and mail a hard copy, along with the digital file in physical form, such as a thumb drive or a CD, to a separate ‘documentation’ office.” (New Yorker)
On February 24, a coalition of public health laboratories writes to the FDA asking for an expedited process for approving the tests that they are developing. Two days later, on February 26, the commissioner of the FDA writes back denying their request saying that “In past experiences with these rolling reviews, the FDA has been able to authorize tests for public health emergencies within as little as 1 day upon receipt of the complete validation.” (Washington Post)
Using Virus Tests
The other fact that is not widely recognized is that the FDA has aggressively pursued people who have “mis-used” tests, for example, by telling public health authorities what the test results were from an unapproved test.
On February 25th, Dr. Helen Chu, who is part of the Seattle Flu Study at the University of Washington, starts running tests for coronavirus without FDA approval and soon finds the first case of community transmission in the United States. Although the FDA approval for the Flu study does not allow her to do so, she alerts public health authorities, who retest the patient the next day. (New York Times)
On February 26, “the investigators and Seattle health officials gathered with representatives of the C.D.C. and the F.D.A. to discuss what happened. The message from the federal government was blunt. ‘What they said on that phone call very clearly was cease and desist to Helen Chu,’ Dr. Lindquist remembered. ‘Stop testing.’ (New York Times)
“On February 28th, Greninger and colleagues sent a letter to Congress, noting, `No test manufacturer or clinical laboratory has successfully navigated the E.U.A. process for sars-CoV-2 to date.’ " (New Yorker)
On February 29, the FDA backs down and says that it will change the process for approving tests developed by clinical labs.
On March 9, local health authorities told the team at the University of Washington to stop testing “until they could finish getting certified as a clinical laboratory, a process that could take many weeks.” (New York Times)
On May 12, the FDA shut down another attempt by the team behind the Seattle Flu Study to work with public health officials to identify the virus in the community:
The SCAN program — which was spun out of the Seattle Flu Study — is a joint effort between researchers and Seattle and King County’s public health department to capture the spread of the virus across the community.
The SCAN effort received emergency clearance for its work from Washington state in March, and was processing test results at certified clinical labs.
The researchers also appear to have misinterpreted the FDA’s guidance on home testing, which has shifted throughout the pandemic. The agency has sought to clamp down on such tests for months, at times sowing confusion in the market among startups. Many of the companies aimed to offer the tests as a partial solution to the nationwide testing shortage but ultimately pulled them from the market after the agency said in March it had not authorized any home test available for purchase.
But on May 11, after a series of updates to its home testing policy, the FDA again clarified its guidance, noting that even tests previously approved by states — including those that processed results in certified labs — needed express authorization from the federal government to continue their work. The next day, the researchers received a notice telling them to stop returning results and immediately complied, the SCAN spokesperson said …
The FDA’s position here is untenable,” said Eric Topol, director of the Scripps Research Translational Institute, which is also tracking the spread of coronavirus. “If they really wanted to foster progress rather than take down our best academic effort to study this virus, that’s what they would do.” (Statnews)
Testing People Who Do Not Have Symptoms
One June 16, the FDA offered new guidance, reminding everyone that there is still no test that is approved for broad testing of asymptomatic individuals.
It did announce a new template that anyone could use to submit an application to do broad testing. But as the experience with getting virus tests approved amply demonstrates, saying that an organization can apply for permission to do something is not the same as saying that it is legal to do it.
But to be fair, we have been assured that it is no longer necessary to send a hard copy of application materials via postal mail.