Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices ("Correcting Misinformation Guidance") and Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices ("Social Media Risk Guidance"). These draft guidances apply to both drug and device manufacturers (referred to generally as "firms" within the draft guidances and this alert).
On a positive note, the Social Media Risk Guidance clearly describes FDA's thinking about promotion in a limited-character format. However, because the document proposes only minor compromises in the existing regulatory requirements for these forms of media, FDA could be criticized for a lack of creativity. In the Correcting Misinformation Guidance, FDA displays a little more willingness to compromise by acknowledging that firms should be able to correct misinformation posted on third-party sites without having to meet all the labeling and advertising requirements, as explained in more detail below.
These are draft guidances, intended to provide insight into FDA's thinking on these matters, and should not be relied upon as final policy. The FDA is seeking stakeholder comments on these documents by September 16, 2014, at www.regulations.gov.
Correcting Misinformation Guidance: Answering Some Questions and Raising Others
In this guidance FDA states that there may be a public health benefit to a firm correcting misleading information about its products. Under this draft guidance, if a firm follows a specific framework when making a correction, it need not comply with the applicable FDA labeling regulations. This exception applies only to a firm correcting misinformation about its own products created or disseminated by an independent third party who is not under the firm's control or influence.
Specifically, the Correcting Misinformation Guidance includes the following directives:
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To be considered "appropriate corrective information," the corrective communication must be relevant, responsive, limited and tailored to the misinformation.
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The corrective communication should be non-promotional in nature, tone and presentation, and should be accurate and consistent with the FDA-required product labeling.
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The FDA-required labeling must be included with the correction or provided in a readily accessible format.
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Links to websites or URLs that are promotional in content or tone should not be included in the corrective communication.
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The corrective communication can be posted directly by a firm in conjunction with the misinformation in the same area or forum, or provided by the firm to the forum operator or author. If provided to the forum operator or author, the communication must clearly reference the misinformation and specify that it is intended to be posted in conjunction with the misinformation.
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The correction must disclose that the person providing the corrective information is affiliated with the firm.
If a firm strays from the prescribed guidelines, the communication will not fall under this exception to the FDA promotional rules.
The following points raised in the draft guidance may be of special interest:
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If a firm chooses to correct misinformation on a particular and well-defined portion of a website, it must correct all of the misinformation (positive and negative) on that portion of the website. This is important to avoid the appearance that a firm is cherry-picking the misinformation it is correcting.
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While FDA emphasizes that firms may correct misinformation on third-party sites that the firm does not control, the duties of "correctors" aren't yet clear. Historically, firms have been fearful that correcting misinformation may create an obligation, perhaps ongoing, to correct all misinformation on a site or assume other duties (e.g., monitoring of discussion for adverse events regarding the firm's products). Firms should bear these issues in mind when deciding whether to become involved with a third-party site.
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According to Example 4 in the draft guidance, a firm is not obligated to correct misinformation posted on a third-party discussion forum that the firm itself hosts (e.g., a website chat room) if the firm includes a clear and conspicuous statement that the firm does not create or control the content of the third-party forum.
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Example 4 also suggests that monitoring this type of hosted forum for profanity and obscenity would not constitute the type of "influence or involvement" that would render the site under the firm's control and thus render any correction subject to the applicable FDA labeling regulations.
The flexibility shown on the part of the FDA in terms of facilitating corrections is commendable. However, because implementing a correction may result in harm to the firm, it may be loath to take advantage of this draft guidance. Further, even after a firm attempts to correct misinformation, there is still the possibility that anonymous bloggers can easily rebut any corrections as illustrated in Example 14 of the draft guidance. The FDA does not expect firms to continue to monitor a third-party website after correcting misinformation. Once a firm engages in correcting misinformation on a third-party site, however, there may be a temptation to continue to engage in discussions that may lead firms to be enticed to provide promotional, rather than correctional, materials. Firms that opt to correct misinformation on third-party sites will want to create clear guidelines for employees to ensure adherence with FDA rules.
Social Media Risk Guidance: Fewer Surprises
The Social Media Risk Guidance, the second of the draft guidances, does not stray far from the labeling requirements for drugs and medical devices, but provides firms a roadmap for key points to include in social media platforms such as Twitter and Google Ads. The following directives are included in the Social Media Risk Guidance:
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Companies must comply with fair balance requirements and ensure that even shortened versions of efficacy statements contain any necessary limitations so as not to be misleading. The most challenging platform will be Twitter, which has a 140 character limit on posts or "tweets."
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If a firm is making a benefit claim, the firm must incorporate the risk and other required information within each tweet. Thus, a tweet about a prescription drug product must contain the brand name of the product, the generic name of the product (but may use abbreviations like "HCl" for "hydrochloride"), any material information necessary to accompany the efficacy message, including indication/intended use (again, abbreviations are acceptable), the most important risk information associated with the product, and a direct link to complete risk information and dosage form/strength for the product. It is clear that FDA expects direct links to the relevant risk information; URLs should not be promotional in tone.
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FDA notes that not all drugs can be promoted in a limited-character format: "If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion)."
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Firms must ensure that the risk information presented does not pose undue product liability risks. For example, determining which risks are relevant to include in a tweet, or determining the proper way to shorten a description of a risk for use in the limited character context could pose some challenges.
Considerations for Moving Forward
Firms that may have been reluctant to enter the space previously may be encouraged to enter it with these clear guidelines. However, there are practical challenges in implementing these approaches. Drug companies may have particular difficulty following this draft guidance because safety information, which the guidance indicates must be included, tends to be quite lengthy. Device manufacturers are better positioned to comply, but they tend to do less direct-to-consumer marketing than drug companies, making this roadmap less useful to them.
Industry stakeholders will no doubt make FDA aware of these perceived compliance challenges in their comments on the draft guidances. They will also likely raise First Amendment issues in light of recent cases challenging the government's ability to regulate commercial free speech. Nothing in these draft guidances changes our previous advice that firms train all employees engaged in social media on the applicable laws and regulations and have social media-specific policies and procedures in place.
