The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate online through social media. The issuance of guidance on social media is mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 1121. FDASIA required FDA to issue social media guidance by July 2014.
In the second of FDA's new guidances, entitled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," FDA provides recommendations to companies that choose to correct third-party information related to their products. FDA uses many helpful examples to answer previously unclear aspects about what companies should do if they encounter false statements about their products from third parties around the internet. We also have an analysis of FDA's other social media guidance on how to provide proper benefit/risk disclosures within character limitations here.
Social media has made it easier for third parties to post information about drugs and devices in real-time, and to a potentially large audience. Information created by third parties, which FDA terms "user-generated content" (UGC), can appear either on a companies' comment section or interactive social media site or on an entirely separate platform that is "not under the control or influence of" that company. Twitter, Facebook, LinkedIn, live podcasts, and blog comment sections allow for real-time and continuous communications and interactions.
However, FDA states, “UGC might not always be accurate and may be dangerous or harmful to the public health. In such a case, “it may benefit the public health for firms to correct misinformation about their products,” including, for example, “situations in which a firm is aware of misinformation that may be dangerous or harmful to the public health.”
Previously, companies have struggled with the best way to approach this type of online misinformation. FDA’s Guidance provides clarity: “If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements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.”
A fundamental question for firms to ask is whether the draft guidance applies to them in a given situation. FDA states that the draft guidance applies when:
- A firm is not responsible for a product-related communication that appears on (1) the firm's own forum, (2) an independent third-party website, or (3) through social media, and
- The firm chooses to correct misinformation about its own product contained in that communication.
Preliminary Issues: Should a firm follow this guidance?
The draft guidance DOES NOT apply: when a firm is responsible for the product communication that contains misinformation. A firm is responsible for communications that are “owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm.” A firm is thus responsible for online communication made by its employees or any agents acting on behalf of the firm to promote the firm’s product. These communications must comply with any applicable regulatory requirements.
Additionally, if a firm writes, collaborates on, or exerts control or influence on product-specific content provided by a third party, to the extent that responsibility for the development of the content is imputable to the firm, the recommendations set forth in this guidance do not apply.
FDA notes that if a firm hosts a discussion group on its own website, monitors the discussion for content that does not speak positively about its product, then removes or edits postings that portray its product in a negative light, and adds positive postings about the product, this firm is exerting control over the UGC and is responsible for the resulting content. Thus, the firm’s actions would not fall under the scope of this guidance.
The guidance DOES APPLY: for UGC about firms products when the UGC is truly independent of the firm (not produced by, or on behalf of, or prompted by the firm), regardless of whether the firm owns or operates the platform on which the communication appears. If the firm owns or operates the platform or created or initiated the forum on which such UGC appears, the firm should include an overarching clear and conspicuous statement that the firm did not create or control the UGC.
Example: A firm becomes aware of a blogger who is posting inaccurate information about the firm’s product. The blogger does not have any relationship with the firm, and the firm is not responsible for the content of the blog. The firm may decide to attempt to correct the misinformation, but it is not obligated to.
Example: A firm hosts a discussion forum about its product’s FDA-approved use on its corporate website and does not participate in the discussion, but monitors the forum for profanity/obscenity. The forum includes an overarching clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for posts by independent third parties and can, if it chooses, correct misinformation according to this guidance.
FDA Recommendations for Correcting Misinformation
Once a firm decides to voluntarily correct misinformation about its own product that is created or disseminated by an independent third party, they can move on to FDA's recommendations. A firm may choose to (1) provide appropriate truthful and non-misleading corrective information or, alternatively, (2) it may provide a reputable source from which to obtain the correct information, such as the firm's contact information.
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 non-promotional 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.
(1) Appropriate Corrective Information
Because risk and other information about the product are not necessarily part of corrective information, the FDA-required labeling should be included or provided in a readily accessible format. As two examples, a firm may provide a link that goes directly to the FDA-required labeling or may provide a link that opens a new window to a portable document format (PDF) file. The information should not be provided by including a link to a promotional website even if the information is available on the promotional website. FDA states that if the address where viewers are directed to obtain the respective FDA-required labeling is promotional in content or tone, FDA would not consider the corrective information to fall within the scope of this draft guidance.
Example: A firm discovers a chat room where participants are discussing the firm's product for one of its approved indications—diabetes. The firm finds misinformation posted by an independent third party about the diabetes indication that the firm would like to correct according to this draft guidance. Although the product has multiple approved indications, the firm should limit its corrective information to the relevant diabetes indication being discussed.
Example: An independent third party writes an online post stating that one reason he likes taking a prescription drug (or using a device) is that it has no food restrictions, which is inconsistent with information from the required labeling regarding the need to avoid taking the drug with fatty foods (or to avoid using the device in a certain way). The firm decides to correct the misinformation according to this draft guidance. The firm's representative identifies herself as being affiliated with the firm and posts the corrective information from the required labeling. She also includes a direct link to the FDA-required labeling.
(2) Correcting a Clearly Defined Portion of a Forum
FDA understands social media forums contain vast amounts of information and notes that it would be unreasonable for a firm to have to correct all misinformation about a product. They clear up an important question firms have had: “[i]f a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum.” However, “a firm should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and should correct all the misinformation that appears in that clearly defined portion.”
A firm should describe the location or the nature of the misinformation that was corrected and should provide a date the correction is made to ensure that parties reading the information do not assume the firm has responded to the entire forum.
Example: A firm decides to correct misinformation posted by an independent third party on one page of an interactive website. The misinformation consists of three consecutive sentences about the firm’s product. The firm should correct all three sentences. It should provide a statement that the firm is responding only to the specified information on that one page and provide the date the change was made. The firm is not expected to correct misinformation that appears on other webpages of the website.
Example: A firm decides to correct misinformation posted by an independent third party who has commented on a blog that allows comments. The firm should correct each piece of misinformation in the particular comment to which it is responding. The firm should provide a statement that it is responding only to one particular comment along with the date the correction is provided. The firm is not expected to correct misinformation that appears in other comments.
FDA states that a firm must correct all misinformation in the clearly defined portion of the forum it identifies. FDA provides a situation where the company in a sense “promotes” its product by deleting only negative false statement. Even if the firm corrects the misinformation in the limited posts it chose, the firm’s actions are not in accord with this guidance because it has intentionally selected only negative information about its product to correct while readily accessible and visible positive misinformation was not corrected.
(3) Approaches to Correcting Misinformation
FDA does not prescribe the exact method for which a company must correct misinformation. They note that firms may provide corrective information to the independent author for the author to incorporate, they may request the author remove the misinformation, or they may consult with the site administrator. FDA understands that third parties may not always cooperate with corrections: “FDA will not hold a firm accountable for an independent third party’s subsequent actions or lack thereof.”
(4) Communications That Fall Outside the Scope of this Guidance
FDA does not expect the firm to continue to monitor the website or communication that previously included UGC containing misinformation. However, when a communication by or on behalf of the firm to the UGC author, site administrator, or the forum goes beyond the correction of misinformation, the communication falls outside the scope of this draft guidance.
FDA concludes its guidance by noting that it does not expect firms to submit corrections to the Agency when correcting misinformation pursuant to this draft guidance. However, FDA recommends that firms keep records to assist in responding to questions that may come from the Agency. The records should include, for example, the content of the misinformation, where it appeared, the date it appeared or was located, the corrective information that was provided, and the date the corrective information was provided.
As noted above, FDA will not object to a companies’ corrections if they are provided in a truthful, non-misleading manner pursuant to FDA’s recommendations. Companies should understand that corrections are voluntary, and can only refer back to on-label information.
FDA notes that corrections must be “consistent with the FDA-required labeling for the product, and be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs.” FDA’s guidance provides some clarity, but the fact that a correction could open the door to liability should give companies pause about whether to interact with users on social media. Furthermore, companies may only correct claims based on the companies’ own product. Compliance teams should have tailored corrective information that avoids comparisons with other products that could be seen as promotional in nature.
On the plus side, this guidance does seem to offer firms answers to many previously unclear aspects of social media communication. By providing companies with necessary flexibility, as well as specific, real world-examples, FDA seems to have taken note of stakeholders’ desire for clarity surrounding social media.
One aspect of the guidance that offers welcomed (and necessary) clarity is that if a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum. FDA advises firms to clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and then correct all the misinformation that appears in that clearly defined portion. This clears up confusion around a companies’ responsibility in a long real-time comment section or continuously updated Twitter feed. Without the guidance, companies may have thought this would require continuous monitoring.
A less clear aspect of the guidance involves FDA’s concern that a company will correct only negative misinformation. Companies must take into consideration that FDA expects them to correct both bad information as well as good information. FDA notes that if a company leaves up all the “beneficial” false comments, they are promoting their product in a sense. However, we don’t know what FDA’s standard will be or in what time frame they will look to in making its determination. For example, if a company deletes two posts about inaccurate negative side effects, how long is the company “on the hook” for waiting to see if a user provides incorrect positive information about the product? The real-time capabilities of social media still present many risks for pharmaceutical and device manufacturers.
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register, so, by September 15, 2014. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.