On This Day in Health: June 15, 2020
On June 15, 2020, the U.S. Food and Drug Administration revoked an emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate as COVID-19 treatments in the United States. The authorization had permitted donated supplies from the Strategic National Stockpile to be used for certain hospitalized patients when a clinical trial was unavailable or participation was not feasible. Following a request from the Biomedical Advanced Research and Development Authority, the FDA concluded that the evidence no longer supported the legal criteria for that emergency use. The decision ended a specific pandemic authorization, rather than removing the medicines from their established roles in treating other diseases.
The authorization had been issued on March 28, during the early months of the pandemic, when clinicians were urgently seeking effective treatments. Emergency authorization is different from ordinary drug approval: it permits a defined use when available evidence supports specified statutory findings during an emergency. Those findings include a reasonable belief that a product may be effective and that its potential benefits outweigh its risks. They can change as evidence develops. Laboratory findings and early clinical observations had encouraged interest in the two medicines, but activity in a laboratory or an uncontrolled report could not settle whether a treatment improved outcomes for hospitalized patients. That question required stronger clinical evidence.
By June, the FDA's review included new trial findings and a reassessment of information available when the authorization began. A large randomized study had not shown a benefit in reducing deaths or improving other important hospital outcomes. Evidence for reduced viral shedding had not been consistently reproduced, and the agency judged the suggested dosing unlikely to produce the anticipated antiviral effect. Safety concerns included serious heart rhythm problems and other adverse effects. Taken together, those findings changed the balance underlying the emergency authorization. The revocation was therefore an evidence-based regulatory action about the authorized COVID-19 setting, not a claim that a familiar medicine must be either useful for every disease or useless for all of them.
The FDA emphasized that hydroxychloroquine and chloroquine remained approved for other indications, including malaria-related uses and, for hydroxychloroquine, conditions such as lupus and rheumatoid arthritis. Patients receiving an established treatment for those conditions faced a different clinical question from the one addressed by the June decision. The episode became an important example of how emergency decisions must remain open to revision. Rapid access under uncertainty carries a corresponding obligation to review emerging results and withdraw an authorization when its basis no longer holds. Remembering June 15 means recognizing that scientific assessment can change the permitted use of a treatment as better evidence arrives, while keeping the scope of that change clear for the people who depend on the medicine for other reasons.
The March 2020 authorization concerned donated stockpile supplies for specified hospitalized COVID-19 patients, not unrestricted approval for prevention or treatment.
An emergency use authorization has different legal criteria from ordinary approval and can be revised or revoked as the evidence changes.
The FDA considered trial outcomes, inconsistent antiviral findings and safety risks in deciding that the authorization's criteria were no longer met.
The action did not revoke established approvals for other diseases. Those uses required separate clinical considerations.
The case illustrates why an emergency decision must be accompanied by continuing review of better-quality evidence.
Clear communication about the scope of a regulatory change helps distinguish an unsupported new use from a medicine's established benefits elsewhere.
Explore more of "On This Day ..."
Discover more events from the same date across news, politics, technology, sports, and other fields. Each link highlights significant moments that shaped history on different fronts.