On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ). The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia in COVID-19 patients, the Agency has concluded that the known and potential benefits of CQ and HCQ do not outweigh the known and potential risks for the authorized uses.” On March 28, 2020, the FDA had approved the use of CQ or HCQ for patients with COVID-19. In May, President Trump revealed that he had taken HCQ as a preventative treatment. In a letter to the Biomedical Advanced Research and Development Authority (BARDA), the FDA stated that the decision to revoke the EUA is based, in part, on the following:
- The suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect.
- Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between HCQ and standard of care alone.
- Current U.S. treatment guidelines do not recommend the use of CQ or HCQ in hospitalized patients with COVID-19 outside of a clinical trial, and the NIH guidelines now recommend against such use outside of a clinical trial.
- Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID-19.
The letter also provides that FDA-approved HCQ may continue to be distributed in interstate commerce but the CQ products covered by the EUA have not been approved for any indication, and therefore will no longer be able to be introduced into interstate commerce. Additionally, the HCQ and CQ previously distributed from the strategic national stockpile under the EUA may still be used “to continue to treat any hospitalized patient to whom the product has already been administered during the COVID-19 public health emergency, to the extent found necessary by such patient’s attending physician.”
Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse related to the COVID-19 pandemic.