As FDA’s workload buckles under the strain, Trump again accuses the agency of a political hit job
Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”
The FDA is working as hard as they can to win back the confidence of the general public, Marks added. “There are forces currently that are creating … incredible doubt in vaccines in this country … it makes me shudder.”
Later that day at a campaign rally in Florida, President Donald Trump cast aspersions on the motivations of FDA staff to institute stronger guidelines for the coming vaccine EUAs. Using the pronoun they, Trump cited unnamed officials, telling his supporters: “They are trying to do a little bit of a political hit. ‘Let’s delay the vaccine just a little bit.’ Did you notice that?”
The agency has been squarely in his sights since an Aug. 22 tweet where he said: “The deep state, or whoever, over at the FDA is making 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, FDA chief Stephen Hahn appears to be getting no support from his direct superior, Alex Azar. The HHS secretary told Trump on Wednesday that Hahn acted alone in pushing the new guidelines, according to a Politico report that cites a senior administration official and another person briefed on the call. Now, senior Trump officials want to see a “fuller justification” from Hahn and the FDA.
While the new standards may still be approved by Trump, their current status is unclear.
Marks’ CBER has 1,200 staffers tasked with regulating biologics, cell therapies, and vaccines. At the SVB Leerink forum he confirmed that, after a positive readout from one or more of the pivotal trials, the trials would be unblinded, allowing sponsors and the agency to monitor patients for Covid-19. Electronic pharmacovigilance will be used to monitor efficacy for short, medium and long-term immunity.
Marks went on to explain that a streamlined EUA review will allow for a flexible CMC evaluation. The usual bits like consistency between lots and some elements of QA/QC validation can be submitted in a fuller BLA, after the EUA.
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