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Politics, Policy & Law

Former FDA leaders call out White House for undermining FDA 

Sep 30, 2020 | 1:04 AM GMT

Hours before the first presidential debate, seven former FDA commissioners called out the “deeply troubling ways” the White House is pressuring the agency in its decisions related to COVID-19 countermeasures.

“A safe and effective vaccine will not be enough; people will also have to choose to take it,” the commissioners wrote in an op-ed in The Washington Post. “This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”

The op-ed — signed by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andrew von Eschenbach — comes less than a week after President Donald Trump undercut efforts by his own top health officials to persuade the Senate and the American people that career staff will make COVID-19 vaccine decisions free from political influence.  

FDA Commissioner Stephen Hahn and CDC Director Robert Redfield had stressed to members of the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) that the public could have confidence that COVID-19 vaccines will be safe and effective because science, not politics, will guide every regulatory decision (see “Trump Contradicts Hahn”). 

Guidance on vaccine authorization “has to be approved by the White House,” Trump said just hours later. He expressed skepticism about any steps that may delay authorization and cast aspersions on the integrity of FDA staff. “We may or may not approve that. That sounds like a political move because when you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with the vaccines, and they’ve done testing and everything else, I’m saying why would they have to be adding great length to the process?” 

In their op-ed, the former commissioners cited other “concerning actions” including a memo from HHS Secretary Alex Azar that appears to clip the wings of HHS agency heads, “significant misstatements” by Azar and other political leaders about the benefits of hydroxychloroquine and convalescent plasma, and an Axios-Ipsos poll showing that 42% of Americans lacked trust in FDA (see “Controversy over Azar Memo”; Commentary: “FDA Should Maintain ‘Social Distance’ from the White House”).

In the 114 years since President Theodore Roosevelt signed a bill to create FDA, the former leaders wrote, staff at the agency “have created a consumer safety net that has been a worldwide model for evidence-based public health policy.” They underscored the importance of the public knowing that agency leaders spoke “on behalf of experts whose judgments were grounded in science.”

If the FDA 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. Without that trust, our health and economy could lag for years,” they wrote.

Kessler is an adviser for the Vice President Joe Biden’s presidential campaign. 

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