One reason the coronavirus fight has been hampered is America’s lumbering regulatory state:
Entrepreneur Elon Musk, President Donald Trump, and New York’s Governor Andrew Cuomo have each touted chloroquine, a drug used to treat malaria, as a promising treatment option for those infected with Covid-19. Some media quickly pounced on the president’s statement. The commissioner of the Food and Drug Administration, Stephen Hahn, quickly clarified that the agency had not in fact approved the drug as a safe and effective treatment for the new disease, shortly after the president claimed that the drug was “approved very, very quickly and it’s now approved by prescription.”
Chloroquine is in fact available for prescription in the United States. It’s already being tried as a treatment for the new virus in U.S. hospitals. And multiple manufacturers are rushing to produce more and get it to doctors.
The confusion over chloroquine—along with the broader performance of U.S. regulatory agencies during this epidemic—highlights how our federal process for reviewing and approving drugs and medical devices still leaves much to be desired. Our regulatory regime is costing lives. The early administrative failings of the FDA and Centers for Disease Control, which greatly worsened the crisis in the United States, show how ugly that can be.
Getting a new pharmaceutical compound to market in the U.S. is an extraordinarily complex process. Development time is usually more than a decade. Costs add up to hundreds of millions, if not billions, of dollars. After an innovator submits an Investigational New Drug application, the FDA requires a three-stage testing process, then the submission of a formal New Drug Application that typically includes hundreds of thousands of pages of documentation.
Some Chloroquine discussion skipped.
With cases and deaths growing exponentially, federal regulatory authorities can be expected to fast-track new approaches. The agencies were much less willing to afford latitude to the private sector just weeks ago, though—and the United States is now much more vulnerable as a result. Chinese authorities uploaded the SARS-CoV-2 genome onto the Internet on January 10. The CDC developed its own testing protocol by January 21; international scientists developed a different test by the same date, which was soon disseminated en masse by the World Health Organization.
The U.S. testing process failed. The day that the CDC announced it had developed its testing protocol, January 21, was the date of the first documented American case of coronavirus. South Korea documented its first case the same day. But by March 17, the United States had administered only 125 tests per 1 million people; South Korea had administered more than 5,000 tests per 1 million over the same time span. By aggressive testing, South Korea was able to trace viral spread and contain it. Without it, the U.S. was left with little choice but the draconian measures that have shut down much of American life.
As has been widely reported, the CDC’s in-house testing design was flawed, thus compromising early testing results. Mistakes happen, but the impact of the test-design flaw was much greater than it should have been—owing to the U.S. bureaucracy’s tightly controlled process. Even had the CDC test worked perfectly, not nearly enough tests would have been available for wide-scale testing on the South Korean model.
We’re happy to note that in recent days and weeks, President Trump has helped ease the regulatory burden of our response to the coronavirus, pushing Health and Human Services, the Food and Drug Administration and the Centers for Disease Control, our main health agencies, to bend, suspend and in some cases upend useless rules.
But that doesn’t mean every useless regulation was excised from the rulebooks. Or that our major health care regulators made good decisions with the billions of dollars entrusted to them for basic research.
Far from it. And the coronavirus pandemic and the public panic that ensued is a case in point. To be blunt, U.S. health care regulatory agencies mishandled the crisis.
Indeed, both the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) fumbled the ball early when it came testing for the Wuhan coronavirus, largely because of bad regulations.
“Even now, after weeks of mounting frustration toward federal agencies over flawed test kits and burdensome rules, states with growing cases such as New York and California are struggling to test widely for the coronavirus,” the New York Times noted in a March 11 story. “The continued delays have made it impossible for officials to get a true picture of the scale of the growing outbreak, which has now spread to at least 36 states and Washington, D.C.”
The Times highlights Dr. Helen Chu, who early on had taken swabs from the noses of patients in Washington State who seemed to be suffering from a particularly nasty virus. She proposed to local, state and federal officials testing those swabs for unusual coronavirus infections.
Instead, the CDC told Dr. Chu she’d have to get FDA approval for her test. The FDA nixed it because the lab she worked in wasn’t “certified” to conduct such tests, something that takes months to do.
So early data that could have helped fight what later became a raging pandemic weren’t available. All because a bureaucracy went strictly by the book.
Let’s hope the current crisis results in significant regulatory reform.
Tags: Center for Disease Control, coronavirus, Regulation, Wuhan