ABOVE: © ISTOCK.COM, TAIZHAN SAKIMBAYEV
A few weeks ago, the World Health Organization rejected the use of Gilead Sciences’s remdesivir for hospitalized patients with COVID-19, regardless of disease severity. This decision is in direct contrast to the US Food and Drug Administration’s emergency use authorization (EUA) of the drug, and President Donald Trump’s glowing endorsement. It’s also a reflection of the steep price of EUAs—the price of undermining medical science.
The FDA can grant an EUA to a drug to treat COVID-19 to facilitate the distribution of new therapeutics when there are no alternatives. EUAs are an important tool during the early stages of any pandemic because they loosen restrictions on novel treatment options. The problem is that they end up interfering with clinical trials that would provide the best evidence on whether these drugs are safe and effective.
The EUA means it is “reasonable to believe” that the drug ...