FDA draft guidance addresses medical misinformation

The US Food and Drug Administration (FDA) has proposed a draft guidance that would give medical device manufacturers more leeway in responding to misinformation about their products. The guidance comes as the agency has spent the past few years trying to dispel COVID-era misinformation that may have caused thousands of deaths.

On 8 July 2024, FDA released the draft guidance, which is intended to replace a similar guidance from 2014. While misinformation can be transmitted in many ways, the document mainly addresses online misinformation.

“The spread of misinformation on the internet can be particularly rapid and harmful when the misinformation is shared by an internet user who has a large follower base or holds a position of trust, since those users may have a wider range or higher degree of influence,” according to the draft guidance. “Additionally, misinformation about or related to medical products that treat or prevent serious or life-threatening diseases is especially concerning and represents a significant public health concern.”

Combating medical misinformation has been one of FDA Commissioner Robert Califf’s biggest priorities since he took office. He has repeatedly noted that life expectancy in the US is declining despite access to new treatments and blamed it in part on misinformation regarding medical products.

Stakeholders can comment on the guidance on www.regulations.gov under docket no. FDA-2014-D-0447 until 6 September 2024.