A top Trump official dismisses a report that he pushed the F.D.A. to soften new vaccine guidelines.
The White House chief of staff, Mark Meadows, dismissed reports that he had pressured the Food and Drug Administration to soften new, stricter guidelines that the agency was preparing for the emergency authorization of coronavirus vaccines.
“Why would we do that?” he asked Margaret Brennan on the CBS program “Face the Nation” on Sunday.
Mr. Meadows said he was interested in the guidelines purely as a matter of quality control: “My challenge to the F.D.A. is just make sure it’s based on science and real numbers.”
The new guidelines under development would lay out more specific criteria for clinical trial data than the current guidelines, and would recommend that the data be vetted by a committee of independent experts before the F.D.A. authorizes any vaccine, according to several people familiar with a draft.
President Trump suggested on Wednesday that the new guidelines were a “political move,” and that the White House might not approve them.
The same day, Mr. Meadows called Stephen Hahn, the F.D.A. commissioner, and insisted that the agency provide detailed justification for the new guidance, according to a report in The Washington Post.
Ms. Brennan asked why the White House would insert itself into the F.D.A.’s process, raising concerns of political interference. “We want to make sure that it’s safe,” Mr. Meadows replied. “We’re trying to make sure that the guidance we give is not an inhibitor to getting things out fast,” but also “doesn’t detract from it.”
Ultimately, he added, the F.D.A. guidelines would make sure that everyone who gets the vaccine “can do that with some kind of assurance that the process is meted out properly.”
Mr. Meadows’s line of reasoning echoed that of Michael Caputo, the former spokesman for the Department of Health and Human Services, when he responded to reports two weeks ago that he and one of his aides had pressured the Centers for Disease Control and Prevention to alter its weekly disease assessments.
The aide “makes his position known, and his position isn’t popular with the career scientists sometimes,” Mr. Caputo told The Times on Sept. 12, a day before he made outlandish claims against C.D.C. scientists in an online video and a few days before going on medical leave. “That’s called science. Disagreement is science.”
Also on “Face the Nation,” Scott Gottlieb, who was commissioner of the F.D.A. from May 2017 to April 2019, said that the expected guidelines did not represent “a revision in the agency standards or any kind of higher bar” but rather “an articulation of the principles and standards that the F.D.A. has been using for a long time and frankly been communicating to the companies that are developing vaccines.”
Dr. Gottlieb, a physician now on the board of Pfizer, one of the companies racing to develop a coronavirus vaccine, said he believed that there was wide agreement that the guidelines, as discussed publicly, “were mostly in line with everyone’s expectations.”
He said he preferred to have the F.D.A. issue the guidance…