COVID-19 has shown us how dysfunctional the American regulatory state can be
There’s a risk to rushing tests, treatments and technologies through the regulatory process. But there’s a risk to regulatory sclerosis, too.
In November, the Food and Drug Administration approved the first rapid at-home coronavirus test.
That would seem to be unabashedly good news. But it’s actually an indictment of federal regulators, who have moved at a snail’s pace in the fight against the coronavirus. These delays have been concerning for folks in Utah, where testing has recently dipped — yet cases are currently skyrocketing.
It’s been 11 months since scientists sequenced the virus’s genome. The FDA didn’t release guidance for at-home tests until July, four months after officials began ordering people to stay home. Even this newly approved test requires a prescription, which sort of defeats the purpose of “at-home” tests — and limits their potential reach.
The government and some public health elites have defended the slow progress on at-home testing by arguing that the average person won’t be able to accurately administer a coronavirus test or interpret the results. They also claim that rapid at-home tests are less accurate than those administered by health care professionals and analyzed in labs.
The alternative, of course, is that people don’t get tested at all, unless they experience symptoms. We now know that asymptomatic spread is common. Indeed, White House Coronavirus Response Coordinator Dr. Deborah Birx recently said in a conversation with Utah officials that there needs to be increased testing to detect asymptomatic cases.
The tardy rollout of at-home tests is the latest example of federal regulators botching the response to the pandemic. In February, the Centers for Disease Control and Prevention created a coronavirus test that ended up not working. But it was the only one the FDA had approved for use.
At first, the FDA refused to let labs and hospitals create their own tests. It took weeks for the FDA to relax its criteria.
By the end of February, some scientists began testing for the coronavirus in violation of the agency’s rules. One found a case of the virus in a teen with no history of travel to the initial epicenter of the outbreak in Wuhan, China.
The FDA even dragged its feet reviewing vaccines. Pfizer and BioNTech applied for emergency use authorization for their vaccine candidate, which reported a 95% efficacy rate in clinical trials, on Nov. 20.
The agency has some definition of “emergency.” It reviewed the vaccine Dec. 10 — nearly three weeks after Pfizer submitted its application. Utah officials expect to distribute up to 750 vaccines per day. Priority will be given to health care workers.
It’s not just the country’s public health agencies that have stumbled. The Federal Aviation Administration has frustrated the efforts of at least one airport to use federal funds to check passengers for the coronavirus.
In May, Eastern Iowa Airport in Cedar Rapids prepared a plan in partnership with a local hospital that would screen travelers before they went through security. Those who failed the initial screen could be connected remotely to a doctor.
Six months later, the FAA still hasn’t told the airport whether it can proceed with its plan.
Absent action from the federal government, airports in more than a dozen U.S. cities, from Kennedy and LaGuardia in New York to Oakland International in California, have opened their own testing sites in partnership with commercial vendors and health systems.
Results can be had in 15 minutes for a rapid test or up to 72 hours for the more accurate PCR test. In some cities, the tests are free to travelers or billable to insurance. In others, passengers must pay for screening themselves.
Over 320,000 Americans have died of COVID-19, including more than 1,100 in Utah. Who knows how many of those deaths could’ve been avoided if regulators had been quicker to review and approve at-home tests?
There’s a risk to rushing tests, treatments and technologies through the regulatory process. But there’s a risk to regulatory sclerosis, too. We must demand better performance from our regulatory state.
Sally C. Pipes is president, CEO and the Thomas W. Smith fellow in health care policy at the Pacific Research Institute. Her latest book is “False Premise, False Promise: The Disastrous Reality of Medicare for All” (Encounter 2020). Follow her on Twitter @sallypipes.