TRUMP PUSHES FDA FOR QUICK APPROVAL OF TREATMENT
Clearance sought for antibody therapy given to president
WASHINGTON
President Donald 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.
Trump and White House Chief of Staff Mark Meadows have called FDA Commissioner Stephen Hahn to urge him to accelerate the agency’s review of the drug, a cocktail of laboratorymade antibodies made by Regeneron Pharmaceuticals, according to the two officials, who spoke on the condition of anonymity because they were not authorized to discuss the efforts.
Critics say that by inserting himself into the approval of treatments — as he did with hydroxychloroquine and convalescent plasma — Trump risks further undermining trust in regulators and confusing Americans, noting that his own hopeful story may not ref lect 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 is 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 said 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 said 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 approved, 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 “political hit job” in a tweet Tuesday, just hours after the White House agreed to the criteria.