Former FDA commissioner Scott Gottlieb said Sunday that he rejects President Trump’s claim that the “deep state” at the FDA is delaying coronavirus treatments and vaccines for political reasons, telling CBS News’ “Face the Nation”: “It is a foundational truth that what guides that agency is science.”
Why it matters: Gottlieb served as FDA commissioner for two years under the Trump administration. He pushed back on claims from Trump and White House chief of staff Mark Meadows that the agency’s bureaucrats don’t understand the “urgency” of the moment, saying: “To say these products aren’t moving at a historic pace I think is wrong.”
Driving the news: Trump plans to announce at a press conference Sunday an emergency use authorization for convalescent plasma, which has already been given to more than 70,000 individuals, the Washington Post reports.
- Many scientists and physicians say the convalescent plasma might be helpful in treating patients, but warn that it’s far from a breakthrough. The plasma is rich in antibodies but there isn’t enough evidence to conclusively say it works.
- Last week, the New York Times reported that the FDA was close to granting an emergency authorization for plasma, but that top health officials intervened because they believed that data from recent trials was too weak.
What they’re saying: “I think a lot of that was about plasma, that tweet,” Gottlieb said. “There were perceived delays in authorizing plasma under emergency use authorization. It was reported this week that NIH had some misgivings about FDA going forward with that authorization.”
- “But there’s reasons some people have some questions about that,” he added. “The trial that that’s going to be based on, 70,000 patients, wasn’t a very rigorously done trial.”
- “I believe plasma’s probably beneficial, it’s probably weakly beneficial in the setting of this treatment. But I think some people wanted to see more rigorous data to ground that decision. I think that’s part of what is going on here with respect to that tweet and questions about the FDA decision-making.”
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