Normal approval from the U.S. FDA for medicines involves applying for and receiving a BLA or Biologics License Application. In unusual cases, however, the regulatory agency will grant a drug company an alternate form of permission to distribute their medication via EUA or Emergency Use Authorization. FDA EUA’s can only be granted if and when three criteria are met: 1) No other treatment exists for the disease in question; 2) The condition causes deaths; 3) Preliminary research demonstrates provisional safety and efficacy.

In yesterday’s vaccine advisory panel meeting, a representative from the FDA characterized EUA drugs as underproven. In other words, EUA medications are essentially experimental and require further research and evidence before full FDA licensure can be conferred. As investigational medicines, EUA status comes with certain caveats and limitations. For example, pharmaceutical companies are barred from marketing EUA products via the usual advertising methods.

A number of medications have already been granted EUA’s by the FDA in 2020, with several authorizations offering cautionary tales. Hydroxychloroquine was granted EUA status on March 28th which was summarily revoked on June 15th for lack of reliable scientific evidence. Remdesivir—a drug its maker Gilead prepared to mass produce in January, in advance of any research findings—received EUA status for treating COVID-19 based on an NIH study stopped prior to its completion date. Despite a later WHO analysis of trials featuring over 7,000 participants showing that Remdesivir to be ineffective, the agency not only chose not to rescind the EUA but actually moved forward, granting a BLA. Most recently, baricitinib, a drug from Eli Lilly for treating arthritis, was given EUA for its ability to shorten recovery time in COVID patients by just 24 hours. Given the drug’s known potential for severe adverse effects, including blood clots, and its high cost—approximately $1,500 per patient—the FDA has drawn sharp criticism from healthcare watchdogs.

As the number of COVID cases skyrockets and more Americans die, appropriate EUA’s granted for safe and effective vaccines and drugs are a matter of life-and-death. Issuing EUA’s, however, demands solid science, free from the influence of politics or profit, and astute judgment fueled by an unflinching commitment to public welfare. Prematurely granting an EUA for hydroxychloroquine played a role in driving global research into its use for treating COVID-19 patients, squandering enormous financial and human resources. One can only hope that the FDA will exercise more rigorous oversight in the future to justify the trust it is asking from the American people as regulators approve more EUA’s with the hope of preventing and treating COVID-19.