In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”. The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious cardiac adverse events and has concluded that the risks do not outweigh the benefits for utilization of these medicines in the treatment of COVID-19.
“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” “said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D.” There has been lots of speculation about political influence and pressure in the days leading up to the March 28, 2020 issuance of the EUA.
The Agency cited the body of information building regarding the lack of effect and potential safety in several controlled clinical studies as support for its decision; however, FDA acknowledges that there are several ongoing studies still evaluating the potential benefits of the two drugs in treating the pandemic. Both drugs remain on the market as approved for use in their approved indications.
This also raises the potential for political pressure on FDA to approve a vaccine before it may be fully tested and found safe and effective. “FDA Commissioner Stephen Hahn denied that political pressure has influenced his agency’s coronavirus response. ‘Under no circumstances will the FDA allow political pressure to affect our decision-making and, importantly, that has not occurred on my watch,’ he told POLITICO.” (See story “White House pressure for a vaccine raises risk the U.S. will approve one that doesn’t work” written by Sarah Owermohle in Politico on June 15,, 2020 here.)
Time will tell!
