As omicron rips across the United States, the Biden administration has started handing out 1 billion rapid COVID-19 tests to Americans. But households are limited to just four tests. And they’ll have to wait nearly two weeks for their tests to arrive in the mail. In some states, the omicron wave may have passed by the time they receive their free tests.
It’s a too-little, too-late approach to a problem bureaucrats could have solved months ago. Had federal officials acted expeditiously to approve more at-home tests, market competition would have naturally driven down the cost — and increased the availability — of tests.
To date, Congress has allocated more than $82 billion in taxpayer money to support testing efforts. Yet tests are still in short supply across much of the country.
For that, the U.S. Food and Drug Administration deserves a significant share of the blame. Over the course of the pandemic, the agency has received more than 4,500 emergency use applications for COVID-19 tests. It has approved just 14 for at-home use.
One FDA reviewer who left the agency over its slowness to approve tests told news outlet ProPublica that many of the applications he reviewed stalled with his superiors for months after he gave them the green light.
Perhaps that’s because FDA leaders have long resisted the very idea of at-home tests. In a 2020 New England Journal of Medicine article, two top FDA administrators argued that ordinary Americans couldn’t be trusted to administer tests in their own homes. Only a doctor, the article said, could be trusted to “interpret results for patients.”
It wasn’t until the end of 2020 that the FDA changed course and approved the first at-home antigen test. However, many continue to sit in regulatory limbo, more than a year later.
Consider LumiQuick Diagnostics, a California-based biotech firm whose rapid test languished for several months awaiting FDA authorization. Unable to sell the tests domestically, LumiQuick opted to ship them to Germany instead.
U.S. officials have pledged to expedite the sclerotic approvals process. This past October, the National Institutes of Health announced it would invest $70 million to create an “accelerated pathway” for manufacturers seeking approval for their tests. But it still took nearly three months — until mid-January — for the FDA to approve an at-home test through the “accelerated” program.
Since the beginning of the pandemic, the FDA has essentially refused to give Americans the tools they need to protect themselves from COVID-19. It dawdled for months before approving the vaccines. It still hasn’t approved tests that are available in Europe.
The pandemic has now given us more than two years’ worth of evidence that America’s regulatory bureaucracy needs a serious overhaul.
This would start with new leadership that transforms the FDA’s mistake-adverse culture. For almost its entire existence, the agency has erred on the side of caution, requiring literal truckloads of documents and data and deliberating for many months, or even years, before approving drugs, medical devices and other products.
On occasion, that caution has proven wise. In the late 1950s and early 1960s, the agency famously withheld approval from thalidomide, a drug that European regulators had approved to treat morning sickness. The medicine ultimately turned out to cause serious birth defects.
But too much caution can be dangerous, too.
Had the FDA not demanded that Pfizer extend its vaccine trials by several weeks — even though the drugmaker originally felt it had enough data to move forward with an application for emergency use authorization before the 2020 presidential election — at least 6,000 American deaths, and perhaps as many as 100,000, could have been averted thanks to an earlier vaccine rollout.
It’s not just vaccines or drugs where these regulatory delays cause real harm. The CDC recently recommended that people wear N95 respirators. But these masks have been hard to find in some areas — in part because the FDA is sitting on a backlog of over 140 applications to produce and market them. Manufacturers are required to obtain FDA approval before they can advertise N95s on Amazon, Google or social media.
Once again, the agency’s excess caution is counterproductive. Even if a particular manufacturer’s N95 isn’t quite as effective as other brands, it’d almost certainly be more effective than the real-world alternative — cloth masks, surgical masks or no masks at all.
We’re in an emergency. It’s time for our regulators to act like it — instead of dawdling and letting the perfect be the enemy of the good.
Sally C. Pipes is president, CEO and Thomas W. Smith fellow in Health Care Policy at the Pacific Research Institute.
Bureaucratic red tape is deadly
Sally C. Pipes
As omicron rips across the United States, the Biden administration has started handing out 1 billion rapid COVID-19 tests to Americans. But households are limited to just four tests. And they’ll have to wait nearly two weeks for their tests to arrive in the mail. In some states, the omicron wave may have passed by the time they receive their free tests.
It’s a too-little, too-late approach to a problem bureaucrats could have solved months ago. Had federal officials acted expeditiously to approve more at-home tests, market competition would have naturally driven down the cost — and increased the availability — of tests.
To date, Congress has allocated more than $82 billion in taxpayer money to support testing efforts. Yet tests are still in short supply across much of the country.
For that, the U.S. Food and Drug Administration deserves a significant share of the blame. Over the course of the pandemic, the agency has received more than 4,500 emergency use applications for COVID-19 tests. It has approved just 14 for at-home use.
One FDA reviewer who left the agency over its slowness to approve tests told news outlet ProPublica that many of the applications he reviewed stalled with his superiors for months after he gave them the green light.
Perhaps that’s because FDA leaders have long resisted the very idea of at-home tests. In a 2020 New England Journal of Medicine article, two top FDA administrators argued that ordinary Americans couldn’t be trusted to administer tests in their own homes. Only a doctor, the article said, could be trusted to “interpret results for patients.”
It wasn’t until the end of 2020 that the FDA changed course and approved the first at-home antigen test. However, many continue to sit in regulatory limbo, more than a year later.
Consider LumiQuick Diagnostics, a California-based biotech firm whose rapid test languished for several months awaiting FDA authorization. Unable to sell the tests domestically, LumiQuick opted to ship them to Germany instead.
U.S. officials have pledged to expedite the sclerotic approvals process. This past October, the National Institutes of Health announced it would invest $70 million to create an “accelerated pathway” for manufacturers seeking approval for their tests. But it still took nearly three months — until mid-January — for the FDA to approve an at-home test through the “accelerated” program.
Since the beginning of the pandemic, the FDA has essentially refused to give Americans the tools they need to protect themselves from COVID-19. It dawdled for months before approving the vaccines. It still hasn’t approved tests that are available in Europe.
The pandemic has now given us more than two years’ worth of evidence that America’s regulatory bureaucracy needs a serious overhaul.
This would start with new leadership that transforms the FDA’s mistake-adverse culture. For almost its entire existence, the agency has erred on the side of caution, requiring literal truckloads of documents and data and deliberating for many months, or even years, before approving drugs, medical devices and other products.
On occasion, that caution has proven wise. In the late 1950s and early 1960s, the agency famously withheld approval from thalidomide, a drug that European regulators had approved to treat morning sickness. The medicine ultimately turned out to cause serious birth defects.
But too much caution can be dangerous, too.
Had the FDA not demanded that Pfizer extend its vaccine trials by several weeks — even though the drugmaker originally felt it had enough data to move forward with an application for emergency use authorization before the 2020 presidential election — at least 6,000 American deaths, and perhaps as many as 100,000, could have been averted thanks to an earlier vaccine rollout.
It’s not just vaccines or drugs where these regulatory delays cause real harm. The CDC recently recommended that people wear N95 respirators. But these masks have been hard to find in some areas — in part because the FDA is sitting on a backlog of over 140 applications to produce and market them. Manufacturers are required to obtain FDA approval before they can advertise N95s on Amazon, Google or social media.
Once again, the agency’s excess caution is counterproductive. Even if a particular manufacturer’s N95 isn’t quite as effective as other brands, it’d almost certainly be more effective than the real-world alternative — cloth masks, surgical masks or no masks at all.
We’re in an emergency. It’s time for our regulators to act like it — instead of dawdling and letting the perfect be the enemy of the good.
Sally C. Pipes is president, CEO and Thomas W. Smith fellow in Health Care Policy at the Pacific Research Institute.
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.