The US Food and Drug Administration declined to consult an outside panel of experts before approving the drug remdesivir as a treatment for COVID-19, Science reports.
It notes that the FDA does not have to convene its Antimicrobial Drugs Advisory Committee — the agency tells it that the decision to do so is up to the division directors — but the University of California, Los Angeles' David Hardy, a member of the committee, tells Science he is "amazed" the FDA did not. By contrast, it notes that the agency convened an outside committee before even having vaccine trial data to review.
Just before the approval, Science notes that the World Health Organization's Solidarity trial found that remdesivir did not reduce mortality among COVID-19 patients or reduce the time it took patients to recover — a trial Science says the FDA did not cite in its approval of the drug.
Additionally Science reports that the European Union and Gilead Sciences, which makes remdesivir, signed an agreement potentially worth $1 billion for the company to provide the drug to the EU just before that trial data was released.
"This is a very, very bad look for the FDA, and the dealings between the Gilead and EU make it another layer of badness," Scripps Research Translational Institute's Eric Topol tells Science.