'Extremely political' — Trump neuters FDA's attempt to strengthen vaccine EUA
Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”
A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.
The remarks set up another critical juncture for the agency and its beleaguered commissioner, who has been working overtime to bolster public confidence in the FDA and his leadership since Hahn’s disastrous performance assisting the president tout false convalescent plasma figures.
The president then questioned the need to lengthen the approval timeline, forecasting “great results” ahead and again framing the FDA’s moves as political:
Because when you have Pfizer, Johnson and Johnson, Moderna, these great companies coming up with the vaccines and they’ve done testing and everything else. I’m saying, why would they have to be adding great length to the process.
It sounded to me, extremely political. Why would they do this, when we come back with these great results. And I think you will have those great results.
The new FDA standards reportedly passed muster at HHS on Tuesday and there was an expectation that it would get a green light from the White House, according to a Politico report that cites two sources familiar with the timeline. Trump reportedly spoke with HHS secretary Alex Azar before the press conference.
Under the new guidance, vaccine developers must follow at least half the participants for 60 days following the second dose, as well as accrue five or more cases of severe Covid-19 in the placebo group, before they can seek an EUA.
It’s still possible the new EUA rules are allowed to go into effect by Trump. But for an agency accustomed to bipartisan deference from its political superiors, it’s now sailing in uncharted waters working under a president who demands key decisions be routed through a command-and-control structure firmly controlled by him or trusted lieutenants. And by having Trump label their work as “extremely political,” it raises new questions on what messaging, if any, FDA leaders can employ that would both satisfy the president and the scientific community.
Trump began Wednesday’s press conference by encouraging Americans to enroll in Covid-19 vaccine trials, and then touted some questionably starry numbers on treatments in the pipeline. “We are seeing promising results that are monoclonal antibodies which help the immune system fight the virus,” Trump said, haltingly reading a script.
But the first question he took was on the peaceful transfer of power after the election. He refused to commit to it.
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