FDA draft guidance aims to give companies leeway to address medical misinformation

The US Food and Drug Administration (FDA) has proposed a draft guidance that would give medical product manufacturers more leeway in responding to misinformation about their products.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On 8 July, FDA released the draft guidance, which is intended to replace a similar guidance from 2014.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or holds a position of trust, since those users may have a wider range or higher degree of influence,” according to the draft guidance.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 (RELATED: Interview: FDA’s Califf talks with Focus about 2023 priorities, Regulatory Focus 21 December 2022).

Medical industry stakeholders, including sponsors, manufacturers, and distributors, are legally limited in what they can communicate about their products. FDA said that the draft guidance is intended to empower stakeholders to voluntarily address misinformation.

"Regulated industry plays a critical role in ensuring consumers have accurate information about medical products,” said Califf in a statement. “We've updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing."

The draft guidance is in Q&A form and gives recommendations on two types of communication that can be used to rebut misinformation: internet-based tailored responsive communication and general medical product information communication.

“Although TV and radio advertisements disseminated by firms are not within the scope of the enforcement policy outlined in this guidance for firms’ tailored responsive communications, firms can share general medical product communications, including TV and radio advertisements, to support diverse strategies for addressing misinformation,” said FDA. “Firms can also consider using general medical product communications in a variety of settings, internet-based or not, to address misinformation that is disseminated in a non-internet-based communication.”

There are limitations on the kinds of misinformation stakeholders can respond to using tailored responsive communications. FDA noted that its guidance does not apply to independent third-party communications that could be described as opinions or value statements about their product, and neither does it apply to statements about individual patient experiences. However, in cases where third parties make false, inaccurate, or misleading statements about the safety, efficacy or approved use of the product, stakeholders are allowed to respond to protect public health.

“Note that the enforcement policy outlined in this guidance is not limited to situations in which the firm’s approved/cleared medical product is explicitly named in the identified misinformation,” the draft guidance said. “For example, the identified misinformation may include false information about an entire class of drugs or category of devices that includes a firm’s approved/cleared medical product (e.g., ‘statins cause earlobe enlargement’). In that case, a firm could choose to use a tailored responsive communication if one of the firm’s approved/cleared medical products is included in the referenced class of medical products.

“Because, under this policy, FDA does not intend to enforce certain requirements that help ensure that the information firms disseminate about their medical products is truthful, non-misleading, and consistent with the FDA-required labeling, it is important that this policy be drawn sufficiently narrowly so that it helps support firms’ voluntary efforts to address misinformation but does not undermine the purposes of those requirements,” the agency added.

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

Draft guidance

FDA draft guidance aims to give companies leeway to address medical misinformation

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