Pharma, device groups ask for more leeway to address misinformation

Stakeholders want the US Food and Drug Administration (FDA) to give them even more leeway in responding to misinformation about their products. Some of the proposed changes include looking beyond enforcement discretion and online communications, addressing how artificial intelligence (AI) aggregation may affect misinformation, and dealing with people impersonating a company or its officials.

Several stakeholders gave feedback on a recently published draft guidance issued by FDA that would give medical product manufacturers more leeway in responding to misinformation about their products. Medical industry stakeholders, including sponsors, manufacturers, and distributors, are legally limited in what they can communicate about their products, but the agency said it plans to use its enforcement discretion in certain cases to empower stakeholders to voluntarily address misinformation. (RELATED: FDA draft guidance aims to give companies leeway to address medical misinformation, Regulatory Focus 8 July 2024)

While commentators overwhelmingly supported FDA’s efforts, several stated that the agency did not go far enough to aid them in combating misinformation.

The pharmaceutical industry lobby group PhRMA has recommended several changes to the guidance, including removing any reference to using enforcement discretion as a basis for the guidance. It said the kinds of responses FDA presents in the guidance are not regarding advertising, labeling, or evidence of intended use, which are a matter of law, and therefore, enforcement discretion is not warranted.

“The scope of the tailored responsive communications contemplated by the draft guidance is narrow and limited to correcting identified misinformation, and does not include making claims to foster the sale, purchase, prescribing, or use of a particular medicine,” said PhRMA. “Such communications are far removed from communications that would meet the legal definitions for advertising, labeling, or evidence of intended use, and we are concerned that FDA’s grounding of the guidance in ‘enforcement discretion’ could suggest otherwise.”

PhRMA has also asked FDA to broaden the scope of medical products and uses covered by the guidance; allow companies to respond to misinformation beyond internet‐based communications; allow them to respond to opinions, value judgments, or personal experiences that are contrary to what the agency approved in the product's labeling; and allow more flexibility for how recommended disclosures are included in their responses.

PhRMA notes that the proposed guidance requires companies to abide by certain disclosures, such as including a mechanism for obtaining a copy of the current FDA‐required labeling; the date the firm’s tailored responsive communication was posted; and a disclosure that the communication was shared by the company or someone acting on behalf of it.

“PhRMA supports these disclosures, which are consistent with PhRMA’s Principles, but FDA should explicitly provide firms with flexibility rather than mandate a particular approach,” said PhRMA.

“In any particular communication, a firm may be able to respond clearly with the appropriate disclosures to ensure the communication is truthful and not misleading without including the disclosures in both audio and visual components,” the group added. “Additionally, given that tailored responsive communications are not properly viewed as advertising or labeling when done in conformance with the other recommendations in the Draft Guidance, it is not clear that FDA has authority to make this recommendation regarding the detailed format for a disclosure.”

In its comments, the Association for Accessible Medicines (AMM) urged FDA to emphasize that any response to misinformation by companies is voluntary. The group said the clarification would avoid imposing any unnecessary burdens on companies to monitor for and correct third-party communications and avoid any potential enforcement actions if they do not respond.

AAM also asked FDA to update the examples of how companies can use tailored responsive communications to tackle misinformation, arguing some of the examples currently may be unworkable and deter companies from responding to misinformation. It noted that in some examples, the statements are considered false, inaccurate, or misleading partly because there is no evidence to support the claims.

“However, in most cases, it will be difficult if not impossible for a firm to determine that there is ‘no evidence,’” said AAM. “More often, there will be some evidence, albeit of dubious scientific validity, and the claim could qualify as misinformation.”

“FDA should provide examples of how firms could qualify for the enforcement policy in these more nuanced situations,” the group added. “The guidance also should address how firms can address situations in which there is a published study, but it is not scientifically valid.”

The medtech lobby group AdvaMed recommended some detailed and some general changes to the guidance, including adding an FDA email account or contact information for companies to contact the agency when dealing with misinformation. The group said it would be especially helpful to companies dealing with misinformation related to emerging technologies and other future developments.

“New technology sectors will continue to develop, and misinformation will remain an important topic,” said AdvaMed. “It could benefit FDA and industry to have a concise point of contact for new forms of misinformation, similar to how [the Center for Devices and Radiological Health (CDRH)] has done for important topics such as sterilization or other general matters.”

AdvaMed asked FDA to provide more guidance on how companies can tackle third parties who are spreading misinformation by impersonating them.

“Through unverified (or verified) technological accounts and deep fakes, impersonation of a pharmaceutical or device company and its leadership or employees is possible,” said the group. “We have already seen this occur on social media platforms by independent third parties impersonating a drug company and/or CEO.”

AdvaMed also that AI isn’t sufficiently addressed in the guidance. It recommended that the FDA address misinformation or exaggerated communications caused by AI aggregation, where the information can’t necessarily be traced to a single source.

“As AI and its adoption expand, it becomes increasingly difficult – or impossible – to address the source that is generating certain information that is exaggerated, inaccurate or misinformation based on the sources used,” the group said.

The Alliance for mRNA Medicines (AMM) also wrote to FDA, but rather than ask for changes, it highlighted how misinformation has played a key role in spreading conspiracy theories about the COVID-19 vaccines. It said it worries that such misinformation could adversely affect future mRNA treatments coming to market.

“Investors and innovators may be reluctant to invest as heavily in mRNA technology and products if they are concerned misinformation about the technology has become pervasive,” said AMM. “Having language such as FDA provides in the Combating Misinformation draft guidance will be valuable to AMM member firms and the broader AMM community.”

“By updating this draft guidance with examples of how firms can push back on social media misinformation regarding their products and technologies, FDA is providing a valuable service to our members’ efforts to improve patients’ lives,” the group added. “Even our members outside of the U.S. applaud the examples and framework outlined in the guidance. While these firms are not bound by FDA regulations in their home countries, they eagerly look to FDA in matters like combating misinformation.”

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Pharma, device groups ask for more leeway to address misinformation

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