Califf, past FDA chiefs look for partners to curb misinformation

Regulatory NewsRegulatory News | 09 January 2023 |  By 

Clockwise from top left: Robert Califf, Mark McClellan, Margaret Hamburg, Scott Gottlieb

Past and present commissioners of the US Food and Drug Administration (FDA) say the agency needs partners in combatting public health misinformation, and industry, clinicians, patient advocates and academic leaders all have a role to play.
 
“Realistically, FDA needs help,” Mark McClellan, MD, PhD, who served as FDA Commissioner from 2002-2004, said at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).
 
While there is currently a lack of trust in officials from public health agencies, individuals still have trust in their own physicians, community leaders, and others who are “close to their experience,” McClellan said during a panel discussion among past and present FDA commissioners about how to counter the problem of misinformation and restore trust in the agency.
 
Janet Woodcock, MD, the agency’s Principal Deputy Commissioner who served as Acting Commissioner from 2021-2022, said patient advocates are trusted and often aligned with FDA’s mission but that their reach is often limited to the disease areas where they are focused, leaving prevention and treatment of common diseases as areas where misinformation can proliferate.
 
“I actually believe that misinformation is the leading cause of death right now in the US because whether we’re looking at COVID or chronic disease, people are making bad choices driven by the information that they get,” said FDA Commissioner Robert Califf, who also served in that role from 2016-2017. “We were just not prepared for what broad access to the Internet would do to communication channels.”
 
Califf called out the academic community for not doing more on the misinformation front and said some of their criticism of FDA and other public health agencies is having unintended consequences.
 
“As a public agency, we need to be critiqued, but I think often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there,” Califf said. “So, they’re critiquing it to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution.”
 
Safe harbor for sponsors
 
Scott Gottlieb, MD, who served as FDA Commissioner from 2017 to 2019, said rapid response to online misinformation is critical and floated the idea of giving industry more leeway to counter false or misleading information about products. “We’ve seen FDA weigh in, admirably, around some dangerous disinformation on specific products,” he said. “But that can’t be the business of the FDA.”
 
Instead, Gottlieb proposed that FDA consider creating a limited safe harbor to allow sponsors to respond directly to “true misinformation.” FDA could use guidance to define how sponsors could respond, based on substantial clinical experience or real-world evidence. Additionally, there would have to be limits, he said, such as not creating a new intended use, limiting responses to only false and misleading statements, and responding on the same platform as the misstatement.
 
“I think sponsors need to have the ability to defend their products in the marketplace of ideas when there’s true misinformation,” Gottlieb said. 
 
Califf said he’s also been thinking about ways to address this problem. “The Internet has 24 by 7 freedom, but those whose products are being vilified have their hands tied because of all the regulations and issues that they worry about,” he said.
 
Transparency and the future
 
Margaret Hamburg, MD, who served as FDA Commissioner from 2009-2015, said that while some of the larger issues around misinformation are difficult to solve, FDA can take concrete steps to restore public confidence in its role. That boils down to showing why FDA matters, how the agency does its work and opening up some of the processes that have historically not been transparent, she said. 
 
“Despite so much that is going on that is hard for FDA to control, the work of the agency and its trustworthiness can be demonstrated,” Hamburg said.
 
That transparency is especially important in areas where there is the most controversy, McClellan said.
 
Looking to the future, Gottlieb said politicians continue to see an “upside” in running against public health agencies and advice. “We’re going to go through a political cycle where there will be multiple national politicians campaigning against public health,” he said. “It’s going to get worse before it gets better.”
 
Califf warned that public health agencies are at risk and that in the current political environment, “people who don’t believe in public health” could end up in charge of public health.

 

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