Americans who have COVID-19 but lack symptoms should only isolate for five days, according to new guidance issued by the Centers for Disease Control and Prevention last week. That’s a significant improvement over the agency’s previous recommendation of 10 days.
The revised guidelines have sparked fierce debate because the CDC included no directive that a person test negative for COVID-19 before leaving isolation. But it’s hard not to notice that tests are in short supply. In many places, they’re not available at all. So a testing order might well have been impossible to follow.
Since his first day in office, President Biden has promised to vastly expand the availability of at-home testing. Right before Christmas, he said that the federal government would send 500 million at-home tests to American households.
It’s unclear where he’ll find them. A dearth of at-home tests remains one of the biggest obstacles to combatting the virus. And for the most part, a sclerotic, overly cautious Food and Drug Administration is to blame.
Early in the pandemic, it was clear that easy access to COVID-19 tests would be critical to any successful response. According to some public health experts, had rapid at-home testing been widely available in 2020, this lingering pandemic could have been over by now.
So it’s more than a little maddening that two years after COVID-19 arrived on our shores, rapid tests remain rare commodities.
This didn’t have to be the case. Given the important role of at-home testing in containing this public health threat, the FDA could have shown far more urgency in approving more of these products for sale over the counter.
Instead, the agency allowed countless at-home testing applications to languish for months. It issued guidance in the first months of the pandemic that required at-home tests to be almost as sensitive as laboratory tests — an unreasonable, and ultimately harmful, demand. By the time the Delta variant arrived last summer, only a few companies were authorized to sell their tests in the United States.
In some cases, U.S. test manufacturers that lack federal authorization, such as LumiQuick Diagnostics Inc. in California, have shipped their rapid tests abroad — even as domestic supplies dwindle and infections surge. A number of foreign test manufacturers are eager to ship their products stateside but can’t because of regulatory hurdles.
The FDA’s sluggish, unpredictable approval process hasn’t just kept potentially life-saving at-home tests from reaching American patients. It’s discouraged many companies from developing these products in the first place.
If a firm is to invest or attract the capital needed to develop, manufacture, and distribute large quantities of at-home tests, then it must be somewhat confident that regulators will approve their product while demand remains strong. The FDA has done little to inspire such confidence.
There is also plenty that the Biden administration could have done to avoid this regulatory bottleneck and ramp-up testing production over the past year. Public health experts Michael Mina and Stephen Phillips have suggested that the president could have issued an executive order allowing tests to be regulated as public health tools instead of medical diagnostics.
So the United States has missed yet another opportunity to reduce the intensity of this crisis. Particularly with a variant like omicron, which seems to provoke much less severe symptoms than earlier forms of the virus, testing early and often could help curb COVID-19’s spread.
With more ample supplies of at-home tests, many of the most contentious questions surrounding America’s response to omicron could have been avoided entirely.
Fans of big government should remember this episode the next time they tout yet more regulation as the solution to some crisis. If the pandemic has taught us anything, it’s that government regulation is not cost-free. It can be deadly.
Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is “False Premise, False Promise: The Disastrous Reality of Medicare for All,” (Encounter Books 2020). Follow her on Twitter @sallypipes. Read Sally Pipes’ Reports — More Here.
The Feds Continue to Fail Their Covid-19 Test
Sally C. Pipes
Americans who have COVID-19 but lack symptoms should only isolate for five days, according to new guidance issued by the Centers for Disease Control and Prevention last week. That’s a significant improvement over the agency’s previous recommendation of 10 days.
The revised guidelines have sparked fierce debate because the CDC included no directive that a person test negative for COVID-19 before leaving isolation. But it’s hard not to notice that tests are in short supply. In many places, they’re not available at all. So a testing order might well have been impossible to follow.
Since his first day in office, President Biden has promised to vastly expand the availability of at-home testing. Right before Christmas, he said that the federal government would send 500 million at-home tests to American households.
It’s unclear where he’ll find them. A dearth of at-home tests remains one of the biggest obstacles to combatting the virus. And for the most part, a sclerotic, overly cautious Food and Drug Administration is to blame.
Early in the pandemic, it was clear that easy access to COVID-19 tests would be critical to any successful response. According to some public health experts, had rapid at-home testing been widely available in 2020, this lingering pandemic could have been over by now.
So it’s more than a little maddening that two years after COVID-19 arrived on our shores, rapid tests remain rare commodities.
This didn’t have to be the case. Given the important role of at-home testing in containing this public health threat, the FDA could have shown far more urgency in approving more of these products for sale over the counter.
Instead, the agency allowed countless at-home testing applications to languish for months. It issued guidance in the first months of the pandemic that required at-home tests to be almost as sensitive as laboratory tests — an unreasonable, and ultimately harmful, demand. By the time the Delta variant arrived last summer, only a few companies were authorized to sell their tests in the United States.
In some cases, U.S. test manufacturers that lack federal authorization, such as LumiQuick Diagnostics Inc. in California, have shipped their rapid tests abroad — even as domestic supplies dwindle and infections surge. A number of foreign test manufacturers are eager to ship their products stateside but can’t because of regulatory hurdles.
The FDA’s sluggish, unpredictable approval process hasn’t just kept potentially life-saving at-home tests from reaching American patients. It’s discouraged many companies from developing these products in the first place.
If a firm is to invest or attract the capital needed to develop, manufacture, and distribute large quantities of at-home tests, then it must be somewhat confident that regulators will approve their product while demand remains strong. The FDA has done little to inspire such confidence.
There is also plenty that the Biden administration could have done to avoid this regulatory bottleneck and ramp-up testing production over the past year. Public health experts Michael Mina and Stephen Phillips have suggested that the president could have issued an executive order allowing tests to be regulated as public health tools instead of medical diagnostics.
So the United States has missed yet another opportunity to reduce the intensity of this crisis. Particularly with a variant like omicron, which seems to provoke much less severe symptoms than earlier forms of the virus, testing early and often could help curb COVID-19’s spread.
With more ample supplies of at-home tests, many of the most contentious questions surrounding America’s response to omicron could have been avoided entirely.
Fans of big government should remember this episode the next time they tout yet more regulation as the solution to some crisis. If the pandemic has taught us anything, it’s that government regulation is not cost-free. It can be deadly.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.