US FDA Communication Ahead Of Major Actions Could Counter Misinformation, Ex-Official Says

Instead of waiting until after regulatory events like COVID boosters and Aduhelm, FDA should describe its decision-making process along the way to help restore public faith in the agency, former deputy commissioner Josh Sharfstein says.

Josh Sharfstein speaks during Prevision Policy's 2021 BioPharma Congress
Josh Sharfstein argues that FDA should be more proactive in combating misinformation. • Source: Biopharma Congress screenshot

The US Food & Drug Administration should maintain constant communication with the public in the leadup to significant regulatory decisions – like the Aduhelm accelerated approval and the authorization of COVID-19 vaccine boosters – in order to combat the barrage of misinformation that muddles messages and damages the agency’s credibility, former deputy commissioner Josh Sharfstein said.

“The standard model for FDA is to wait until it makes a decision and then try to communicate that,” Sharfstein...

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