Trump Threatens To Nix FDA Proposal For Stricter Vaccine Standards
"That has to be approved by the White House. We may or may not approve it. That sounds like a political move," President Donald Trump said about a draft FDA plan to apply tougher safety and efficacy requirements for emergency use approval of a COVID-19 vaccine.
President Trump said on Wednesday that the White House 鈥渕ay or may not鈥 approve new Food and Drug Administration guidelines that would toughen the process for approving a coronavirus vaccine, and suggested the plan 鈥渟ounds like a political move.鈥 The pronouncement once again undercut government scientists who had spent the day trying to bolster public faith in the promised vaccine. Just hours earlier, four senior physicians leading the federal coronavirus response strongly endorsed the tighter safety procedures, which would involve getting outside expert approval before a vaccine could be declared safe and effective by the F.D.A. (Gay Stolberg, 9/23)
Trump was apparently reacting to a Tuesday report in the New York Times that said the agency will soon move to tighten requirements for emergency authorization of any coronavirus vaccine to better ensure its safety and effectiveness. "That has to be approved by the White House. We may or may not approve it. That sounds like a political move," Trump said during a press briefing at the White House. (Wise, 9/23)
The stricter FDA standards cleared a review by the Department of Health and Human Services on Tuesday, with the expectation that the White House would soon approve them, according to two people with knowledge of the timeline. Trump鈥檚 remarks came hours after he spoke with HHS Secretary Alex Azar about the FDA proposal, two people familiar with the situation said. The president's criticism throws into jeopardy an effort viewed as key to boosting public confidence in any eventual coronavirus vaccine. (Morello and Cancryn, 9/23)
Trump said he had 鈥渢remendous trust in these massive companies鈥 developing prospective vaccines and suggested that they, not federal regulators, could best determine when a vaccine should be made available to the American people. 鈥淲hen you have great companies coming up with these vaccines, why would they [the FDA] have to be, you know, adding great length to the process? We want to have people not get sick.鈥 鈥淚 don鈥檛 see why it should be delayed further,鈥 he said. 鈥淭hat is a lot of lives you鈥檙e talking about.鈥 (Goldstein and McGinley, 9/23)
