“I don’t know of any precedent where the White House asked to adjudicate scientific and clinical guidances, even in past public health emergencies,” said Scott Gottlieb, Trump’s first FDA commissioner. White House officials are especially interested in the agency’s recommendation that manufacturers provide safety data for their clinical trial participants for a median of two months after they get their second vaccination shot. Trump has repeatedly clashed with the nation’s top health agencies throughout the coronavirus response and undermined his health officials from the White House podium. When asked about the FDA’s new guidance, Trump said he thought the new standards sounded “like a political move” and warned the White House might reject them. “That is a lot of lives you’re talking about.”The guidance initially seemed to move through the approval process as expected.

Source: Washington Post September 25, 2020 23:58 UTC