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Trump pushes FDA to quickly clear coronavirus antibody treatments, erroneously calling them a ‘cure’

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Fri, 2020-10-09 12:46 — mike kraft
Trump pushes FDA to quickly clear coronavirus antibody treatments, erroneously calling them a ‘cure’ He vows the drug will soon be broadly available to Americans — even as the company says it would have enough this fall to treat only the number of Americans sickened in the past week. Carolyn Y. Johnson, Laurie McGinley, Josh Dawsey Washington Post

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.

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 laboratory-made 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 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.”..

 

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COVID-19
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Fri, 2020-10-09 17:30 — mike kraft

The drugmaker behind the experimental COVID-19 treatment remdesivir has announced how much it will charge for the drug, after months of speculation as the company tried to figure out how to balance profit and public health needs in the middle of a pandemic.

In the United States, Gilead Sciences will charge $520 per vial for patients with private insurance, with some government programs getting a lower price. With a double-dose the first day, that comes out to $3,120 for the five-day treatment course. For governments in developed countries outside the U.S., it will cost $390 per vial, or $2,340 for the five-day course. How much uninsured patients would pay is still unclear. ...

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