The Real-Life Costs of Bad RegulationEarly administrative failings of the FDA and the Centers for Disease Control greatly exacerbated the Covid-19 crisis in the United States.James R. Copland
March 24, 2020 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.â€
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.
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