Seven former commissioners of the Food and Drug Administration have lashed out at the Trump Administration, arguing that political interference threatens to undermine the agency’s credibility as it prepares to approve a coronavirus vaccine.
“If the F.D.A. makes available a safe and effective vaccine that people trust, we could expect to meaningfully reduce Covid-19 risk as soon as next spring or summer,” the authors wrote. “Without that trust, our health and economy could lag for years.”
The statement, published as an opinion piece Tuesday in The Washington Post, was unusual not only for its sharp tone but for the wide political ties of the former commissioners.
Scott Gottlieb was appointed by President Trump and served until April 2019; Robert Califf and Margaret Hamburg, by President Obama; Mark McClellan and Andy von Eschenbach, by President George W. Bush; Jane Henney by President Clinton, and David Kessler by President George W.H. Bush. The position requires a Senate confirmation.
The authors argued that a vaccine must be more than just safe and effective. “People will also have to choose to take it,” they wrote. “This depends on widespread confidence that the vaccine approval was based on sound science and not politics.”
The former commissioners added that the Trump administration was undermining “in deeply troubling ways” the public belief that their judgment was “grounded in science.”
They noted that the White House has said that it might try to influence the F.D.A.’s scientific standards for vaccine approval, or block the agency from issuing further guidance on its criteria for judging a vaccine’s safety and benefits: “This pronouncement came just after key leaders at the F.D.A., the Centers for Disease Control and Prevention and the National Institutes of Health all publicly supported that guidance.”
The implications of the administration’s interference were “potentially dire,” they added. “When the F.D.A. approves a Covid-19 vaccine, will Americans accept it?”