Earlier this year, the United States Food and Drug Administration (FDA) issued a draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs.” Under current law, medical industry stakeholders are often limited in what they are able to communicate about their products. However, in the draft guidance, FDA would allow medical product manufacturers greater leeway in responding to misinformation published about their products.
Most comments in response to the draft guidance were favorable, but some commentors felt that the draft guidance did not go far enough to help allow manufacturers to properly respond to misinformation.
PhRMA, in its response, made several suggested changes to the guidance, including removing references to using enforcement discretion as a basis for the guidance, saying that the responses FDA presented in the draft guidance are not referencing advertising, labeling, or evidence of intended use, which are a matter of law, and therefore, enforcement discretion is not warranted. “The scope of the tailored responsive communications contemplated by the Draft Guidance is narrow and limited to correcting identified misinformation, and does not include making claims to foster the sale, purchase, prescribing, or use of a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. 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 also asked the agency to broaden the scope of medical products and uses covered under the guidance, broaden the scope of misinformation that can be responded to (beyond internet-based communication), and allow for greater flexibility for how recommended disclosures are included in their responses.
AdvaMed also submitted comments, recommending changes to the draft guidance, including the creation of an FDA email account or other contact information for companies to contact the agency when dealing with misinformation. AdvaMed felt that this would be helpful for companies that are dealing with misinformation surrounding emerging technologies, saying, “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 also raised concerns about impersonations, including through both verified and unverified technological accounts and deep fakes, noting that the company has “already seen this occur on social media platforms by independent third parties impersonating a drug company and/or CEO.” Additionally, concerns around artificial intelligence (AI) were raised by the group, with AdvaMed concerned that there isn’t much available in the way of misinformation or exaggerated communications caused by AI aggregation, saying, “[a]s 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 Medical Information Working Group (MIWG) submitted comments in response to the draft guidance as well. In the comments, MIWG believes that the enforcement policy outlined in the draft guidance is “overly narrow and incommensurate with the extent of misinformation that exists online.” As an example, MIWG noted, the enforcement policy does not apply to communications that would address misinformation regarding products with an emergency use authorization (“EUA”), statements describing “opinions or value statements” about a medical product, or representations about an individual patient’s experience using a medical product.” These limitations “make little sense, given that misinformation often comes in these forms and that misinformation related to EUA products for COVID-19, including when framed as opinion or patient experience, has apparently been a major impetus for FDA’s efforts.”