Alerts & Corrections

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. The agency determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. This is the statutory standard for issuance of an EUA. The Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services originally requested the EUA covering chloroquine and hydroxychloroquine, and the FDA granted the EUA on March 28, 2020 based on the science and data available at the time. Today, in consultation with the FDA, BARDA sent a letter to the FDA requesting revocation of the EUA based on up to date science and data.

Read the full press release on the FDA’s website.

The Office of the General Counsel at the Department of Health and Human Services (HHS) has issued an advisory opinion stating that HHS’s guidance authorizing pharmacists to order and administer COVID-19 tests pursuant to the Public Readiness and Emergency Preparedness Act supersedes any state law that would prohibit pharmacists from ordering tests.

Specifically, the advisory opinion refers to utilizing a “qualified person” for COVID-19 response. HHS Secretary Alex Azar declared pharmacists to be a “qualified person” for the purposes of ordering and administering COVID-19 tests on April 8.

ASHP has actively advocated for the ability for pharmacists to order and administer tests in response to COVID-19. We will continue to work with our state affiliates on implementation of emergency orders and seek information on reimbursement for services from the Centers for Medicare & Medicaid Services. We are following up with HHS to determine whether this nationwide authority to conduct testing applies to influenza in addition to COVID-19.