On June 18, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued draft guidance documents addressing the presentation of risk and benefit information for prescription drugs and devices on internet/social media platforms permitting limited character usage, such as Twitter, and regarding how a firm may correct misinformation disseminated by an independent third party concerning a product approved or cleared by FDA. The highly anticipated draft guidance documents come in response to stakeholder requests for specific guidelines.
FDA initiates its discussion of character-limited product promotion by reinforcing regulatory requirements and concepts broadly applicable to product promotion and by maintaining the standard that benefit information should be balanced by the presentation of content- and prominence-comparable risk information. The Agency, however, acknowledges the challenge firms may have in achieving the appropriate balance while also presenting necessary product information. Therefore, at the outset of any such campaign, FDA advises the promoting company to undertake the fundamental evaluation of whether the platform is appropriate for promotion of the particular product. For example, products with complex indications or extensive serious risks may not be amenable to promotion via character-limited platforms.
FDA outlines three components for inclusion in promotion via internet/social media platforms with character space limitations, namely: general factors, risk information disclosure factors, and other product information recommendations.
General Factors. In each communication, benefit information must be accurate, be non-misleading, and reveal material facts, and it should be accompanied by risk information. If adequate benefit and risk information as well as other required information cannot all be communicated within the character limits, FDA encourages the firm to reconsider the platform's use.
Risk Information Disclosure Factors. In each communication, risk information should be presented in conjunction with benefit information, at a minimum disclose the most serious risks for the product, and be presented with comparable prominence to benefit information. Additionally, direct access to a more complete discussion of risk information should be provided to the audience, e.g., a hyperlink routing the audience to a nonpromotional landing page dedicated solely to risk information.
Other Product Information Recommendations. Two additional requirements to be met within the character limitations include the presentation of the promoted product's established name and inclusion of at least one specific dosage form and quantitative ingredient information. FDA indicates that a firm should include the established name directly after the brand name but accepts the use of commonly recognized linguistic symbols in place of words and the use of scientific abbreviations for chemical ingredients to reduce character usage. FDA suggests the latter requirement will be satisfied by inclusion of at least one dosage form and quantitative ingredient information (in conjunction with the brand and established names) on the hyperlinked risk information landing page.
The draft guidance document makes effective use of examples in detailing particular promotion through Twitter and Sitelink extensions of hypothetical drugs. If the prescribed guidelines are followed, the Agency asserts it does not intend to object to promotion via these and similarly character-constrained platforms.
FDA explicitly provides that the draft guidance document is not intended to address product promotion through websites, webpages on social media platforms, online web banners, or responsive web design, maintaining these platforms do not impose the same character constraints as those contemplated by the draft guidance document.
FDA initiates its discussion of dissemination of misinformation by summarizing the problem facing stakeholders. It states that while "the Internet has facilitated the transmission of information, allowing patients and other interested parties the opportunity to share experiences as well as to communicate with others about drugs and devices," such information "might not always be accurate and may be dangerous or harmful to the public health." FDA makes a point to differentiate "communications that are owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm," to which the guidance does not apply. To facilitate the correction of misinformation by third parties, the draft guidance specifies three parameters for how a firm may voluntarily correct the misinformation "in a truthful and non-misleading manner."
Appropriate Corrective Action. The firm should provide information that is relevant, tailored to the misinformation, nonpromotional, accurate, consistent with the product's labeling, and discloses the affiliation of the provider to the firm.
Extent of Misinformation Corrected. Although a firm is not expected to correct all misinformation in a particular forum, the firm should clearly identify the misinformation and the portion of the forum it is correcting, to ensure that readers do not assume the firm has necessarily responded to the entire forum.
Approaches to Corrective Action. The firm may choose among several approaches to making the correction, including correcting information directly on the forum, providing corrective information to the author of the misinformation, or requesting the author to remove the misinformation or allow comments to be posted.
Ultimately, the draft guidance provides a safe harbor of sorts for firms correcting misinformation. First, FDA does not expect the firm seeking to correct misinformation to continue to monitor the forum that contained misinformation. Second, as long as the correction is made in accordance with the guidance, "FDA does not intend to object if these voluntary corrections do not satisfy otherwise applicable regulatory requirements, if any." Finally, FDA does not expect firms to report corrections, but they should "keep records to assist in responding to questions that may come from the Agency."
FDA is accepting comments on both draft guidance documents. Comments are due by September 16.