FDA authorizes COVID-19 plasma treatment amid Trump pressure


The FDA authorization came on Sunday, a day after Trump accused the agency of impeding the rollout of vaccines and therapeutics for political reasons.

“Today I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,” he said during a White House news conference Sunday.

Trump, who has been looking to announce progress in battling the virus, hailed the agency’s decision as a “historic breakthrough”.

This would “dramatically expand access to this treatment,” he told reporters, adding, “This is what I’ve been looking to do for a long time.”

While experts have expressed optimism about convalescent plasma, former FDA Commissioner Scott Gottlieb called the decision “incremental” earlier in the day.

He said thousands of patients can already use the treatment, but the news might make it more widely available.

The authorization also comes amid concerns about whether the agency, under Trump pressure, made such a decision without adequate data about how well it works.

However, the agency said the treatment was safe, citing an analysis of 20,000 patients who received convalescent plasma. It added that 70,000 patients have been treated using the treatment so far.

“It appeared that the product is safe and we’re comfortable with that and we continue to see no concerning safety signals,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters in a conference call.

However on Saturday, Trump tagged the agency’s Commissioner Stephen Hahn in a tweet, saying, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.”

“Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

Meanwhile, Michael Steele, who served as chairman of the Republican National Committee from 2009 to 2011, said the Trump administration was concerned more about politics.

“This is not about good science or even your health, it’s about his re-election,” Steele wrote on Twitter.

Trump previously defended taking the malaria drug hydroxychloroquine to try to ward off the coronavirus, despite the drug’s potentially fatal side effects.

The FDA had warned about potential serious side effects with the use of the drug in COVID-19 patients.

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