President Donald Trump and White House Chief of Staff Mark Meadows are both urging the FDA to quickly grant an emergency use authorization for Regeneron's antibody drug, which the president received as a treatment for COVID-19, The Washington Post reported.
Both men have called FDA Commissioner Stephen Hahn in recent days to urge him to accelerate the agency's review of the drug, two senior administration officials told the Post.
They are also pushing for Eli Lilly's COVID-19 antibody drug, which is similar to Regeneron's, to receive authorization. Both companies said this week that they have applied for emergency authorizations.
The president claimed in videos posted on Twitter this week that Regeneron's drug is a "cure" for COVID-19 and that it would be broadly available soon. Regeneron has said that, in the next few months, it will have only enough supply to treat the number of people in the U.S. who have become sick in the last week, about 300,000 doses the Post reported.
Eli Lilly said it should have about 1 million doses of its antibody drug by the end of the year.
"The fundamental problem with monoclonal antibodies is there’s not enough worldwide capacity to produce enough of them to have a real impact on the disease," Ezekiel Emanuel, a health policy expert who is advising the campaign of Joe Biden, told the Post. "Yes, they might be great, but for a small number of patients."
Many physicians and scientists have said antibody drugs are among the most promising treatments for COVID-19, but clinical trials of the drugs have not been completed.
"Once they issue the [authorization], it will kill the trials, and as a society we will have less information moving forward as far as who does it work in, and who to prioritize," David Boulware, MD, an infectious diseases physician at the University of Minnesota Medical School in Minneapolis, told the Post.
The pressure from the president for the FDA to approve the treatments may make it seem the agency is driven by politics, not science, the Post reported.
"We are very afraid that this will become a political football, where … if we get an [authorization], people will say we didn’t deserve it and only got it because of political reasons. Or if we don’t get an [authorization], people will say we did deserve it and didn’t get it for political reasons. We don’t want this to be a political decision," Regeneron CEO Leonard Schleifer, MD, PhD, said.
Both the White House and FDA declined to comment to the Post.
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