The FDA will allow companies to make “tailored responsive communication” to address misinformation about their approved medical products, according to a new draft guidance.

“FDA does not intend to enforce (with respect to that tailored responsive communication) applicable requirements, if any, related to promotional labeling and advertising or the post-marketing submission of promotional communications,” the guidance said. The FDA said following the guidance recommendations will “empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.”

In addition, in cases where the tailored responsive communication addresses misinformation that suggests that an approved/cleared medical product should be used for an unapproved use and the response is consistent with the guidance recommendations, the “FDA does not intend to use such communication standing alone as evidence of a new intended use.”

“Regulated industry plays a critical role in ensuring consumers have accurate information about medical products. We’ve updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation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,” FDA Commissioner Robert Califf, M.D., said in announcing the new guidance. “The growing spread of rumors about science and medicine continues to put patients and consumers at risk. We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”

The agency noted “this guidance is not intended to address a firm's correction of its own false or misleading representations about its medical products.”

The draft guidance applies to approved/cleared medical products – medical devices for human use, including biological products, prescription human drugs, including biological products, and prescription animal drugs.

The enforcement policy applies when a company voluntarily shares an Internet-based communication that identifies and addresses misinformation that is:

• about or related to the company’s approved/cleared medical product;
• in an Internet-based communication; and
• created or disseminated by an independent third party.

In addition, “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,” the guidance said. “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.”

The guidance included several limitations on the enforcement policy. “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 limitations are:

• TV and radio advertisements are not within the scope of the enforcement even when disseminated by companies via the Internet, such as ads streamed during TV shows.
• In the case of misinformation about or related to unapproved uses of approved/cleared medical products, the enforcement policy is limited to a company’s response to misinformation created or disseminated by an independent third party that suggests that the approved/cleared medical product should be used for an unapproved use.
• The policy does not extend to company responses to statements describing opinions or value statements about an approved/cleared medical product. It also does not extend to responses to representations about an individual patient’s experience using an approved/cleared medical product – whether made by that patient or others.

“Notwithstanding these limits, the enforcement policy outlined in this guidance provides an additional communication avenue for firms beyond preexisting channels for communication and thus expands, rather than restricts, firms’ options for communications,” the guidance said.

The FDA noted companies also “remain free to use other communications to address statements that are not covered by the enforcement policy,” including “independent third-party communications that fall outside the enforcement policy for tailored responsive communications.”

The guidance said there were “many existing avenues available to firms for communicating information about or related to their approved/cleared medical products,” including sales aids, TV and radio ads, and help-seeking and institutional communications. The guidance noted that these communications “are not necessarily Internet-based or prompted by or tailored to address specific identified Internet-based misinformation.” In addition, these “general medical product communications can include, among other things, content and messaging that address misinformation about a firm’s approved/cleared medical product. Inclusion in a general medical product communication of content that addresses misinformation creates no special considerations regarding the application of the FDA authorities or other FDA enforcement policies,” the guidance said. “General medical product communications are expected to comply with all applicable requirements of the FDA authorities, unless the communication is the subject of another enforcement policy.”

The guidance noted that company responses to communications that include opinions, value statements, or representations about an individual patient’s experience do not fall within the enforcement policy.

“However, in cases where an opinion, value statement, or representation about an individual patient’s experience references, either implicitly or explicitly, a basis that falls within the definition of misinformation, a firm’s use of a tailored responsive communication to address the underlying misinformation would be consistent with the enforcement policy” if the response follows the guidance’s recommendations.

What is Misinformation?

According to the guidance, “misinformation refers to implicit or explicit false, inaccurate, or misleading representations of fact about or related to the firm’s approved/cleared medical product.” This includes false, inaccurate, or misleading:

• Representations of fact about or related to approved or unapproved uses of the company’s approved/cleared medical product;
• Representations of fact about or related to instructions/directions for use from the FDA-required labeling of the approved/cleared medical product;
• Representations of fact about or related to an attribute of the approved/cleared medical product that is independent of any particular use, such as statements about where the medical product is made or about the components of the medical product;
• Representations of scientific information about or related to the approved/cleared medical product (e.g., scientific information about a medical product’s risk, effectiveness, or mechanism of action; representations about the type, characteristics, or extent of scientific information about the approved/cleared medical product);
• Representations that omit a fact or facts that are material in light of the representations made or implied about or related to the company’s approved/cleared medical product.

The guidance recommends:

• Tailored responsive communication should clearly identify both the specific misinformation that the company is addressing and a specific Internet-based, independent third-party communication in which that misinformation appears. “For example, a firm might share a tailored responsive communication in conjunction with a specific Internet-based, independent third-party communication or capture and embed an Internet-based, independent third-party communication (or a portion of it) in a tailored responsive communication,” the guidance said.
• When a company identifies misinformation that is widespread, the company “should, at a minimum, clearly identify at least one Internet-based, independent third-party communication that contains the misinformation the firm is addressing. A firm might do this by, for example, noting the date and specific location within the Internet-based setting where the independent third-party communication was posted,” the guidance said. A company also can note that the identified misinformation appears on other social media platforms.
• Tailored responsive communication should clearly identify what specific misinformation within an Internet-based, independent third-party communication the company is addressing. “If a firm indicates that their tailored responsive communication is, for example, addressing just one sentence of content posted by an independent third party in a specific location within an Internet-based setting, the firm should address each piece of misinformation in that sentence,” the guidance said.

In addition, companies should ensure the information in the response is:

• Truthful and accurate.
• Scientifically sound – “Any study or analysis that informs a firm’s tailored responsive communication, at a minimum, should meet generally accepted design and other methodological standards for the particular type of study or analysis performed (e.g., provide a clear description of the hypothesis stated and tested, acknowledge and account for potential bias, and otherwise meet generally accepted scientific standards for the type of study or analysis performed), taking into account established scientific principles. Statistical rigor and validity are generally necessary, but not sufficient, for a study or analysis to be scientifically sound,” the guidance said.
• Directly relevant and responsive to the identified misinformation.
• Limited to the information necessary to address the identified misinformation as well as any recommended disclosures. “This does not mean a firm can omit information that is material to the specific content of the tailored responsive communication,” the guidance cautioned.

The FDA also recommended companies include disclosures in their responses “to help ensure that audiences have the appropriate context to understand the communication:

• A mechanism for obtaining a copy of the current FDA-required labeling (including FDA-approved patient labeling, if any). “This is particularly important because under the enforcement policy – depending on the nature of the identified misinformation – risk information and other key information about the approved/cleared medical product (e.g., the medical product’s full indication) might not be included in the firm’s tailored responsive communication if that information is not directly relevant and responsive to the identified misinformation or material to the information in the tailored responsive communication,” the guidance said.
• The date the company’s tailored responsive communication is posted (if a date is not automatically generated).
• A disclosure that the response is being shared by the medical product company or that the person addressing the misinformation is providing information about the medical product on behalf of the company. “For example: This information is being shared by [Firm X], the maker of [Medical Product Y] [or] This information is being shared on behalf of [Firm X], the maker of [Medical Product Y].”

If a company wants to use a tailored responsive communication to address misinformation that suggests that the company’s approved/cleared medical product should be used for an unapproved use, the FDA recommends that the response include:

• A statement identifying the unapproved use or uses and noting that the unapproved use or uses of the medical product have not been approved by the FDA and that the safety and effectiveness of the medical product for the unapproved use or uses has not been established.
• All recommended disclosures presented clearly and prominently. “Factors to be considered when determining whether information is clearly and prominently presented include, but are not limited to, type size, style of font, layout, contrast, graphic design, headlines, spacing, volume, articulation, pace, and any other techniques to achieve emphasis or notice.

For responses that have both audio and visual components, FDA recommended disclosures be presented in both the audio and in the text at the same time using the same words (key terms and phrases or a full transcript).

There are also several operational and presentational considerations that the FDA recommended a company take into account when addressing misinformation with a tailored responsive communication:

When companies choose to voluntarily address misinformation, they should prioritize misinformation that has current relevance, such as misinformation that is trending or actively spreading on Internet-based platforms, and misinformation that is being spread by independent third parties that have large follower bases or hold positions of trust because those users may have a wider range or a higher degree of influence.

If the setting where a company chooses to post its response has functionality that allows communications to be shared to other settings by a user who is an independent third party, the company should consider whether the shared version of its tailored responsive communication would include the entirety of the original post. “Some settings may not allow the entirety of the tailored responsive communication, including all disclosures recommended in this guidance, to be transferred when a firm has enabled sharing of its post to other settings,” the guidance said.

Companies should consider the layout and format of platform controls (e.g., engagement buttons) to help ensure that the company’s responses, including all disclosures, are not obscured in the setting where the response is posted. “A firm should also consider how the location of platform controls in other settings would impact how its tailored responsive communication would appear in that setting if the firm enabled sharing of its response to that setting,” the guidance said.

When companies enable sharing to other settings, they should consider how the limitations of these other settings may impact their tailored responsive communication. “For example, the inclusion of platform-specific branding or watermarks applied from the use of a specific platform’s built-in video creation tool can limit the distribution of the tailored responsive communication to other settings,” the guidance said.

The new draft guidance revises and replaces the previous draft guidance – “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” – issued in June 2014.

In addition to providing the updated draft recommendations, the FDA said it “will continue to take steps to communicate accurate, up-to-date, science-based information to the public.” Some examples of the agency’s efforts include:

• Providing timely, digestible, factual information to news media and other organizations;
• Creating resources on the FDA’s website and social media to address common questions about the products the agency regulates;
• Participating in speaking engagements to draw attention to the dangers of misinformation and to provide factual information about FDA-regulated medical products and public health issues;
• Providing interested parties with toolkits of resources; and
• Posting memos and other regulatory documents that outline the agency’s decision-making, consistent with applicable law(s).

“The FDA will continue to proactively offer resources about medical products to provide factual and scientifically sound information to the public. The agency remains committed to helping address misinformation and continues to support other interested parties that choose to engage on this critical issue,” the agency said.

Submit electronic comments on the guidance to Docket No. FDA-2014-D-0447 via www.regulations.gov by Sept. 9.