President Trump and a top aide are pushing the Food and Drug Administration to quickly grant emergency clearance for a promising but unproven covid-19 therapy that the president received nearly a week ago and has credited with his rapid recovery, according to two senior administration officials.
Critics say that by inserting himself again into the approval process for treatments — as he did with hydroxychloroquine and convalescent plasma — Trump risks further undermining trust in regulators and confusing Americans since his own hopeful story may not reflect how the drug works for others. In the case of the antibody drugs, however, many physicians and scientists think they are among the most promising approaches to treat covid-19 and there may be enough evidence to support an emergency clearance.
One of the administration officials defended the pressure campaign, saying the president and Meadows want the drug to quickly clear the bureaucracy so they can save lives. “You wouldn’t believe the level of bureaucracy these things get steeped in,” said the official. “We have to speed these things up.”
Another senior official said Hahn has received multiple calls in the last few days from the White House: “The message is clear. Let’s get it done.”
That official, who was worried about the impact of Trump’s politicization of the FDA process, said the White House is pushing for emergency clearance both for the Regeneron drug and a similar one made by Eli Lilly & Co. Both drug companies announced they applied to the FDA for emergency clearance Wednesday.
Both the White House and the FDA declined to comment. An FDA spokesperson pointed to a speech by Hahn earlier this week in which he said, “Every one of the decisions we have reached and that will be made by FDA scientists has been and will be based on science and data, not politics.”
The news that Trump is pressing the FDA directly comes as he wages a social media campaign promoting the drugs, called monoclonal antibodies. He claimed in videos posted Wednesday and Thursday on Twitter that the Regeneron drug is a “cure” that would soon be broadly available — even as the company disclosed that in the next few months, it would have enough supply to treat only the number of Americans sickened in the last week, or about 300,000 doses.
The Lilly drug shows similar promise but will also be in short supply, with about 1 million doses by year’s end.
Trump also claimed in the videos that he himself had granted the drugs an emergency use authorization, which is not the case. “We’re going to make them available immediately; we have an emergency use authorization that I want to get signed immediately,” he said in the video posted Thursday afternoon.
In fact, the FDA reviews are not finished. And people familiar with the thinking of agency insiders say Trump’s tactics are putting the FDA in a difficult position. While the drugs appear on track to be okayed, Trump’s public prodding may make it appear the agency is being driven by politics, not science.
The pressure from the White House comes as Trump and Meadows express increasing frustration with the FDA. The agency’s new guidelines for authorizing a coronavirus vaccine — a move praised by many experts — were described by the president as a “political hit job” in a tweet Tuesday, just hours after the White House agreed to the criteria.
Experts say Trump is also overstating the evidence — in this case boasting that the drugs are a panacea, despite the fact the evidence so far is suggestive that they are helpful in reducing symptoms over several days, not 24 hours; reducing the levels of virus in people’s bodies; and decreasing the need for follow-up medical visits.
His actions also risk disappointing Americans who may be unable to get the drugs.
“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,” said Ezekiel Emanuel, a health policy expert who is advising the campaign of Joe Biden. “Yes, they might be great, but for a small number of patients.”
The president also said in one of his videos that people in hospitals should receive the drugs, but the data so far supports using them in people with mild or moderate illness who have been recently diagnosed.
Trump’s endorsement of monoclonal antibodies comes as the authorization of a coronavirus vaccine before Election Day appears increasingly unlikely. Such an okay had loomed as a potential “October surprise” that some believed could alter the course of the election with the prospect of a quick return to normalcy.
Trump said in one video that the therapies were “more important” than the vaccine, the same day that both companies disclosed that they had filed with regulators for emergency authorization to use the drugs in some patients. On Fox Business on Thursday morning, he called the Regeneron drug “a gift from heaven.”
Both the Regeneron and Eli Lilly drugs are being tested in clinical trials, and no one knows if the former helped Trump recover, whether it did so in addition to all the other treatments he received or whether he would have recovered on his own as part of the natural course of the disease.
Several experts said that Trump touting a drug as a cure will make it even harder to persuade patients to participate in ongoing clinical trials where they will have a chance of receiving a placebo. Those trials will be essential to figure out how well the drugs really work and which patients benefit most from the drug, since there are not enough doses for broad distribution.
“The problem is the president is a single-man wrecking ball,” said Nahid Bhadelia, an infectious-diseases physician at the Boston University School of Medicine. “He’s destroying the mechanisms by which we figure out the efficacy of drugs, touting one thing and then another.”
“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,” said David Boulware, an infectious-diseases physician at the University of Minnesota Medical School. “There’s going to be a limited supply.”
In an interview earlier this week before Trump’s video was posted, Leonard Schleifer, chief executive of Regeneron Pharmaceuticals, said his company wanted regulators to decide when their drug merits an authorization for emergency use based on the data.
“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,” Schleifer said. “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.”