September 29, 2020 at 9:06 PM EDT
Seven former FDA commissioners accuse Trump administration of undermining the agency
By Laurie McGinley and Reis Thebault
In a rare and extraordinary rebuke, seven former commissioners of the Food and Drug Administration wrote an op-ed accusing the Trump administration of interfering politically with the agency, with potentially catastrophic effects on public trust in a coronavirus vaccine.
The column, which was published online Tuesday afternoon in The Washington Post, detailed a recent pattern of interference, including President Trump’s threat to reject a proposed FDA guidance detailing the criteria the agency will use to judge a coronavirus vaccine, and decisions by Health and Human Services Secretary Alex Azar to revoke the FDA’s authority to regulate lab-developed tests and to sign its own rules.
Trump and Azar have imperiled the FDA’s ability to “make the independent, science-based decisions that are key to combating the pandemic and so much more,” the commissioners wrote.
The letter was signed by agency chiefs who have served in Democratic and Republican administrations over three decades: David Kessler, who worked for George H.W. Bush and Bill Clinton; Jane Henney, who worked for Clinton; Mark McClellan and Andrew von Eschenbach, who worked for George W. Bush; Margaret Hamburg and Robert Califf, who worked for Barack Obama, and Scott Gottlieb, who worked for Trump.
The commissioners said Trump’s effect on the public’s confidence in the FDA is already surfacing in polling data, pointing to a recent Axios-Ipsos poll that found more than 40 percent of Americans didn’t trust the agency to look out for their best interests.
“The implications of the recent shift are potentially dire,” they wrote.
Several of the commissioners have issued joint statements before — for example, on opposing drug importation. But the new letter stands out because it directly criticizes the current administration.
“Political intrusion,” they concluded, “only prolongs the pandemic and erodes our public health institutions.”
In a separate event sponsored by the advocacy group Friends of Cancer Research, Peter Marks, the top FDA career official overseeing vaccines, said the proposed guidance was an effort by the agency to be transparent about its standards. He did not indicate whether the guidance would ever be issued but said the pharmaceutical companies were fully aware of its contents.