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Regulation

FDA leaders should echo career staff in communicating about COVID-19, Gottlieb says

Former FDA commissioner on why he believes in ‘integrity’ of the agency’s processes

Sep 8, 2020 | 7:02 PM GMT

FDA and HHS can increase confidence in COVID-19 regulatory decisions by aligning statements from policymakers with communications FDA crafts for physicians, Scott Gottlieb told BioCentury.

In an audio interview for BioCentury’s Back to School series, the former FDA commissioner acknowledged perceptions that the agency’s decision-making about COVID-19 products has been politicized; however, he said it isn’t clear that the perceptions are accurate, and expressed confidence in the integrity of career staff.

“I don’t think any of us know the true facts of what the interactions have been,” Gottlieb said. “I think the process itself has integrity to it if it’s followed, and I think the perception [of political interference] gets created when there’s a view that the process isn’t followed.”

Pandemic response has pushed the scale and scope of the emergency use authorization (EUA) process far beyond where it has been in previous emergencies. The EUA process has “never been used in the same way before,” Gottlieb said. “In 2009, with H1N1,  there were certain products that were made available under an EUA, but they were things like masks and gloves, they weren’t therapeutics on the scale of what you’re seeing therapeutics being authorized under the EUA process, or diagnostics for that matter.”

There are clear, objective criteria in place for how EUA decisions should be made, and FDA should adhere to these criteria – and be seen to be adhering to them, Gottlieb said.

The key to FDA building public confidence in COVID-19 products, according to Gottlieb, is for its leaders to communicate with the public in the same measured way the agency communicates with clinicians.

FDA professional staff have communicated in a “very appropriate and measured” way about EUAs, he said. “They're saying what they know and what they don't know, and they’re not overstating the robustness of the impact of any of these treatments. I think the policymakers need to echo those same things, and I think that confidence gets eroded when there seems to be a disconnect in terms of how things are being talked about in a policy context and how they’re being talked about in the scientific context by the professional staff who are actually making these decisions.”

The same principle applies to regulatory decisions about vaccines, Gottlieb told BioCentury. “We now have clear objective guidance for what the approvable endpoints are going to be for the vaccine.  I think trying to inspire public confidence in that process is just [a matter of] elevating the professional staff who were working on it, making the criteria by which these decisions get made very clear, and making sure that the communications in the policy realm are the same communications that you’re making in the clinical realm.”

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