FDA Provides Draft Guidance for Industry to Correct Misinformation on Internet/Social Media Platforms

June 18, 2014—In the Federal Register, the US Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” This draft guidance updates and clarifies the FDA’s policies on the correction of misinformation created or disseminated by independent third parties on the Internet or through social media platforms, regardless of whether that misinformation appears on a firm’s own forum or an independent third-party forum or website.

To ensure that the agency considers comments on this draft guidance before it begins work on the final version of the guidance, interested parties are advised to submit comments on the draft guidance by September 16, 2014. Comments on the proposed collection of information should be submitted by August 18, 2014. Electronic submission can be made at http://www.regulations.gov. Written comments can be mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852.

According to the FDA, this draft guidance responds to (among other things) stakeholder requests for specific guidance and describes the agency’s current thinking on how manufacturers, packers, and distributors of prescription drugs and medical devices for human use, including biological products, should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved or cleared products when that information is created or disseminated by independent third parties.

The agency stated that the draft guidance represents the FDA's current thinking on specific aspects of its evolving consideration of social media platforms and other Internet-related matters. The FDA continues to actively review, analyze, and develop approaches to a variety of topics related to the labeling and advertising of medical products, including the development of this and other guidance addressing the use of social media platforms and the Internet.

This draft guidance provides the FDA’s recommendations to firms that voluntarily choose to correct misinformation that appears on the Internet or through social media platforms.

This draft guidance discusses the type of information that is considered misinformation, recommends parameters for corrective information, and recommends approaches to correcting misinformation. It refers only to misinformation that is created or disseminated by an independent third party and that is not produced by or on behalf of or prompted by the firm in any particular.

The agency advised that when a firm chooses to correct misinformation in a truthful and nonmisleading manner and according to the recommendations in this draft guidance, the FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.

However, if a firm chooses to respond to misinformation about its products using nontruthful or misleading information or in a manner other than that recommended in this draft guidance, the FDA may object if the information provided by the firm does not comply with applicable regulatory requirements related to labeling or advertising, if any.

With respect to the following collection of information, the FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of the FDA’s functions, including whether the information will have practical utility; (2) the accuracy of the FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The draft guidance recommends that firms provide appropriate truthful and nonmisleading corrective information, or alternatively, it may provide a reputable source from which to obtain the correct information.

For the purposes of the draft guidance, to be considered “appropriate corrective information,” a firm’s communication should:

• Be relevant and responsive to the misinformation;
• Be limited and tailored to the misinformation;
• Be nonpromotional in nature, tone, and presentation;
• Be accurate;
• Be consistent with the FDA-required labeling for the product;
• Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
• Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
• Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

Also, the FDA-required labeling should be included or provided in a readily accessible format.

The draft guidance recommends that a firm correct all the misinformation in one clearly defined portion of a forum, but it is not expected to correct each occurrence of independent third-party misinformation throughout an entire forum.