Saturday, 26 Sep 2020

Trump says FDA may be delaying plasma approval over politics

WASHINGTON (BLOOMBERG) – President Donald Trump alleged that US health regulators may be delaying the emergency authorisation of blood plasma to treat coronavirus patients until after the election to hurt him politically, offering no substantiation for the charge.

“I hear great things about it, that’s all I can tell you,” Trump said at a White House news conference Wednesday (Aug 19).

“It could be a political decision because you have a lot of people over there that don’t want to rush things because they want to do it after November 3,” the date of the election.

The use of plasma drawn from people who have survived Covid-19 as a virus treatment has been embraced by some doctors.

While seen as safe, clinical trials haven’t yet proved whether the therapy can help people sickened by the coronavirus.

The New York Times reported on Wednesday citing unnamed officials that the US Food and Drug Administration had put a possible emergency-use authorisation for convalescent plasma on hold after infectious-disease expert Anthony Fauci and National Institutes of Health head Francis Collins argued that the treatment was too weak.

In response to the article, the FDA’s Deputy Commissioner for Medical and Scientific Affairs Anand Shah said in an emailed statement that the agency takes “seriously our mandate to follow the data and science on the review of medical products to prevent or treat Covid-19.”

While declining to comment on whether any decision was coming on convalescent plasma, Shah said: “The safe use of convalescent plasma remains available to patients through several pathways, including clinical trials, a national expanded access protocol, or through a single patient emergency investigational new drug request.”

Trump has long maintained that a “deep state” of government bureaucrats opposed to his election have stymied his administration.

“I’ve heard fantastic things about convalescent plasma, I’ve heard numbers way over 50 per cent success, and people are dying and we should have it approved if it’s good,” he said.

The FDA didn’t immediately respond to a request for comment on Trump’s remarks.

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