HydroxychloroquineOn June 15, 2020, the Food and Drug Administration (FDA) withdrew its emergency use authorization (EUA) to use hydroxychloroquine to treat COVID-19. According to the FDA, there is “no reason to believe” the drug is effective against the coronavirus, and its use increased the risk of serious side effects, such as heart problems. The FDA’s action is a stunning about-face. There are now serious questions about how state and federal regulators and enforcement agencies will view the prescribing decision-making that was done in the heated first months of the pandemic.

The Rise and Fall of Chloroquine and Hydroxychloroquine

Chloroquine and hydroxychloroquine, which have been approved by the FDA for decades to treat malaria, lupus and rheumatoid arthritis, became household words in March 2020 when President Donald Trump called chloroquine and hydroxychloroquine a “game changer” in the battle against COVID-19. On March 19, the President, discussing chloroquine and hydroxychloroquine, said, “It’s shown very, very encouraging early results, and we’re going to be able to make that drug available almost immediately.” The next day on Twitter, he exclaimed that “it” [chloroquine and hydroxychloroquine] must “be put in use IMMEDIATELY.” Shortly after the president’s statement, based on limited and now widely-discredited clinical studies, the FDA granted its now-revoked emergency authority. Then, on May 15, 2020, he raised the stakes further by stating publicly that he had started taking hydroxychloroquine to prevent being infected with coronavirus. Asked about the lack of evidence that the drug effectively treats or prevents COVID-19, the president responded, “Here’s my evidence: I get a lot of positive calls about it.”

Pharmacists and Doctors Under Pressure and Patients at Risk

Not surprisingly, the president’s statements and the FDA’s emergency authorization led to substantial public interest in using these drugs to ward off COVID-19. Over the past several months, tens of millions of doses have been distributed to pharmacies around the country and physicians wrote an enormous number of prescriptions for chloroquine and hydroxychloroquine. CBS News reported that, in March alone, “chloroquine orders spiked 3,000% . . . and hydroxychloroquine orders rose 260%.”

Prescribing chloroquine or hydroxychloroquine to treat COVID-19 is not in and of itself unlawful or unethical, as doctors in the United States are generally permitted to prescribe drugs off-label and do so in a wide variety of circumstances. However, the sharp increase in demand raised concerns that prescribers may not have been adequately considering the potentially serious side effects or applying the appropriate standard of care. News stories abound of doctors seeking the drugs for family and friends or asking pharmacists to fill orders for 1,000 pills or more at a time. In one reported case, a veterinarian tried to obtain the drugs from a local pharmacy, presumably for use by humans not animals.

The Future Compliance and Enforcement Ramifications are Unknown

Just like the course of the pandemic itself, the enforcement landscape changes by the day. As the pandemic’s impact continues to evolve, what may have seemed like a reasonable course of treatment a few short weeks ago could draw unwanted attention from federal and state regulators now. What is certain is that after the pandemic abates, law enforcement and regulators are likely to scrutinize conduct occurring during the COVID-19 pandemic: a time of crisis when many individuals, including pharmacists and doctors, were making decisions under difficult circumstances. How the mad dash to prescribe and dispense drugs now deemed ineffective against COVID-19 may be viewed in the future remains to be seen.