The clamor reveals the misperception over the power that the Food and Drug Administration has over doctors’ clinical decisions. And though the FDA last weekend granted emergency authorization for the drugs to be added to the Strategic National Stockpile for use in treating hospitalized COVID-19 patients, the agency does not have the final say over how doctors use drugs that it’s approved. What it can do is prevent or delay urgently needed drugs from getting to patients through its approval process.
At a previous Coronavirus Task Force briefing, President Trump incorrectly told the press that the antimalarial drug chloroquine had already gone through the FDA’s approval process for the treatment of COVID-19 infection. He was later corrected by the FDA commissioner, who said the approval process had not and will not be completed until controlled clinical trials have convinced the agency. People might therefore conclude that doctors are not legally permitted to prescribe chloroquine, or its analog hydroxychloroquine, to treat COVID-19 infections. In fact, doctors around the globe, including in the U.S., are already using these and other drugs to treat their patients, and reporting on their findings in the peer‐reviewed medical literature.
In the March issue of the International Journal of Antimicrobial Agents, a group of French medical researchers reported on chloroquine’s potential based on their experience with a small group of patients. A Chinese medical team reported similar encouraging results in early February. Researchers at the University of Washington in Seattle are using chloroquine to treat their COVID-19 patients, with one of its research associates calling the results thus far “very promising.” And a report in the Wall Street Journal by two physicians, including the director of the Division of Infectious Disease at the University of Kansas Medical Center, also touts the drug’s potential.
The use of chloroquine, hydroxychloroquine, and other drugs (such as azithromycin and antiviral drugs used against HIV) to treat COVID-19 are examples of “off‐label” prescribing. Ironically, once a drug is approved for the treatment of the condition for which it was initially intended, the FDA does not restrict its use in other situations. This is called “off‐label,” because the label is only allowed to state the condition for which its use was FDA‐approved.