We already know in general terms that the maze of bureaucracy in D.C. delayed our response to the coronavirus and precipitated the nationwide lockdown. If we had ramped up testing like officials in South Korea, we would have been able to quarantine the sick and let the rest of us get back to work.
But now new details are emerging that describe just how badly the do-nothing bureaucrats in Washington messed this up. According to a devastating timeline published by The Dispatch, the FDA's "emergency use authorization" requirement actually kept private labs from developing the tests we so desperately needed.
January 31: HHS Secretary Alex Azar declared a public health emergency, which initiated a new requirement—labs that wanted to conduct their own coronavirus tests must first obtain an emergency use authorization (EUA) from the FDA. According to reporting from Reuters, the emergency declaration made it more difficult to expand testing outside the CDC:
That’s because the declaration required diagnostic tests developed by individual labs, such as those at hospitals or universities, to undergo greater scrutiny than in non-emergencies—presumably because the stakes are higher.
“Paradoxically, it increased regulations on diagnostics while it created an easier pathway for vaccines and antivirals,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “There was a real foul-up with diagnostic tests that has exposed a flaw in the United States’ pandemic response plan.”This was the moment when the wheels came off the bus. Keith Jerome, the lab director at the University of Washington Virology Lab in Seattle, told The New Yorker how perverse this heightened standard was from a public health perspective:
"From the point of view of the academic labs, we look at it, like, when there’s any run-of-the-mill virus that people are used to, they trust us to make a test. But when there’s a big emergency and we feel like we should really do something, it gets hard. It’s a little frustrating. We’ve got a lot of scientists and doctors and laboratory personnel who are incredibly good at making assays. What we’re not so good at is figuring out all the forms and working with the bureaucracy of the federal government."EUAs were intended to speed up the normal authorization process. But in this case, labs that were already conducting their own coronavirus tests needed to cease operations until they were granted an EUA. By declaring a public health emergency and not waiving EUA requirements, the FDA was actually slowing down the testing process.
The Dispatch cites a GQ report that described one doctor who tried -- and failed -- to obtain the necessary authorization from the FDA. His experience sounds more like navigating a local DMV than working to stop the spread of a global pandemic.
Obtaining an EUA is no quick task. The FDA requires new protocols to be validated by testing at least five known positive samples from a patient or a copy of the virus genome. Most hospital labs have not even seen coronavirus cases yet. An article in GQ magazine detailed how Alex Greninger, an assistant director of the clinical virology laboratories at the University of Washington Medical Center, was forced to navigate a regulatory morass:
After emailing his application to the FDA, Greninger discovered that it was incomplete. It turned out that in addition to electronically filing it, he also had to print it out and mail a physical copy along with a copy burned onto a CD or saved to a thumb drive. That package had to be shipped off to FDA headquarters in Maryland. It was a strange and onerous requirement in 2020, but Greninger complied. He had no choice. On February 20, he overnighted the hard copies of his application to the FDA.
But submitting the physical application wasn’t the end of the process. Before granting the EUA, the FDA wanted Greninger to run his testing protocol against the MERS and SARS viruses:
Greninger complied. He called the CDC to inquire about getting some genetic material from a sample of SARS. The CDC, Greninger says, politely turned him down: the genetic material of the extremely contagious and deadly SARS virus was highly restricted.
“That’s when I thought, ‘Huh, maybe the FDA and the CDC haven’t talked about this at all,’” Greninger told me. “I realized, Oh, wow, this is going to take a while, it’s going to take several weeks.”
Bureaucratic overreach hurts Americans in good times and in bad. Why do we allow it to continue?
The executive and legislative branches have little incentive to shrink the bureaucratic state -- it's one of their most effective tools to subjugate the American people.
That's why we need to call an Article V Convention of States. A Convention of States doesn't require the approval of any of the three branches of our federal government. It derives its authority from the people and the states and is entirely controlled by delegations from all 50 states.
At this convention, delegates can propose constitutional amendments that shrink the size, scope, and authority of the federal bureaucracy. These amendments can eliminate useless agencies and force the ones that do exist to reduce their size and work within their constitutional limits.
Bureaucratic red tape should never again hold back the most powerful, most creative country in the world in a time of crisis. We need to get the feds out of our daily lives, and we can do it with a Convention of States.
Sign the petition below to let your state legislator know that you support the Article V option!
