The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers — Internet/Social Media Platforms: Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices (“Guidance on Correcting Third Party Misinterpretation”), and Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (“Guidance on Presenting Risk/Benefit Information”).
As the titles suggest, the purpose of the documents is to clarify how social media may be utilized by drug and medical device companies for the voluntary correction of misinformation provided by independent third parties, as well as for presenting promotional messaging regarding risk/benefit information of products. But while the guidelines provide helpful clarification regarding how such platforms may be utilized, they each also raise considerations that companies should take heed of before beginning to use these outlets, and should be factored into a company’s social media guidelines.
As an initial matter, the Guidance on Correcting Third Party Misinterpretation (“Draft Guidance #1”) establishes two points: first, Draft Guidance #1 only applies to misinformation posted to Internet-based platforms by an independent third party, therefore excluding content provided by the company itself, its employees and agents. Second, Draft Guidance #1 establishes that the exception to a company’s obligation to respond to or correct misinformation only applies to information that is “truly independent,” for example posted by an independent third party to an unaffiliated platform or a platform providing content that is not controlled by the company.
However, Draft Guidance #1 does not completely exclude company-operated sites. In stark contrast with the company’s obligation to correct content when that content is “owned, controlled, created …influenced or affirmatively adopted or endorsed by, or on behalf of, the firm,” where such corrections are obligatory and also carry advertising and labeling regulatory requirements, Draft Guidance #1 does not hold companies responsible for correcting misinformation where a company owns or operates an online platform that allows for user-generated content (chat room, etc.) over which a company does not exert control. However, Draft Guidance #1 cautions that such a site should contain an “overarching and conspicuous statement that the firm did not create or control the [user-generated content].”
If a company chooses to voluntarily respond to truly independent misinformation, Draft Guidance #1 sets parameters on the process for taking correction action, which should either be by (i) providing appropriate truthful corrective information or (ii) providing “a reputable source for correct information, such as the firm’s contact information. In either approach, in order to constitute “appropriate corrective information” a firm’s communication should denote the affiliation of the corrective post with the company, and be:
relevant and responsive to the misinformation;
limited and tailored to the misinformation;
non-promotional in nature, tone, and presentation;
consistent with the FDA-required labeling for the product;
supported by sufficient evidence; and
posted either in conjunction with or reference the misinformation.
In acknowledgement of the vast nature of the Internet and certain forums and the reality that it may be impractical for a company to attempt to correct all misinformation about its products that may appear, Draft Guidance #1 stipulates that companies do not need to address all incorrect information that may be posted regarding a particular drug or device, even if a company elects to correct a selective portion. When addressing any misinformation, therefore, Draft Guidance #1 recommends that a company create a figurative box around the particular misinformation and portion of the forum it intends to correct, and then revise all the incorrect information within that defined boundary, which should include also correcting positive misinformation or exaggerations. Following corrective action, while Draft Guidance #1 does not hold companies responsible for monitoring the communication, it does recommend that companies keep records that include (i) the date, location, and content of the misinformation; (ii) when the wrongful information was discovered; and (iii) a description of the corrective information provided, including the date it was furnished.
Finally, Draft Guidance #1 suggests that the FDA does not intend to object if a firm voluntarily corrects misinformation and the voluntarily provided corrective information does not satisfy otherwise applicable regulatory labeling or advertising requirements, so long as the corrective information is not non-truthful, misleading, or in a manner other than recommended by Draft Guidance #1. However, companies should take heed that any corrective action that goes beyond merely providing accurate information that is specifically tailored to the misinformation it is addressing (i.e., including slogans or promotional information) must comply with applicable regulatory requirements related to labeling or advertising.
While helpful for establishing clearly both the parameters for correctly responding to misinformation as well as for clearly limiting a company’s obligation to respond to any or all misinformation posted by an independent third party, the Guidance on Correcting Third Party Misinterpretation also reminds companies to take caution when doing so to ensure that their responses are narrowly tailored enough to fall under the purview of the guidance and outside regulatory requirements. That caution includes carefully considering where misinformation clearly constitutes “truly independent” information. Companies should be mindful of the reality that “truly independent” is not a concept that is well defined, and should thus be cautious before asserting that certain misinformation may fall under the purview of Draft Guidance #1 as the FDA advances a broad interpretation of when a company is responsible for taking corrective action.
Prepared by the Office of Prescription Drug Promotion, the second guidance issued by the FDA last week, the Guidance on Presenting Risk/Benefit Information (“Draft Guidance #2”), addresses the parameters around presenting benefits and risks information on Internet and social media platforms with character spacing limitations, such as microblogs (e.g., Twitter) and online paid search (e.g., “sponsored links” on search engines such as Google). Draft Guidance #2 clearly establishes that, as a threshold matter, the character restrictions do not eliminate the company’s responsibility to ensure its promotional messaging complies with all applicable regulations related to advertising and labeling, and cautions that such forms of media may not be appropriate for promotion of certain products, such as those with complex indications or risk profiles.
For companies that choose to make product benefit claims on character-space-limited communication sites, while each may reasonably use common abbreviations (including scientific and medical abbreviations), punctuation marks, and other symbols to comply with space constraints, Draft Guidance #2 presents a broad set of rules that must be satisfied by each communication relating to both risk and benefit information.
Benefit information should be accurate, non-misleading, and reveal material facts within each individual message or tweet.
Benefit information should be included with risk information in the same message. Do not spread benefit and risk information across multiple messages or tweets.
Risk information should be included with benefit information in the same message. Do not spread risk and benefit information across multiple messages or tweets.
Risk information should be “comparable in scope” to the benefit information, and should, at minimum, include the most serious risks, e.g., those included in a boxed warning or known to be life-threatening, among others, associated with the product. To determine whether risk information is “comparable in scope” to the benefit information, the FDA weighs (i) whether the risk information “qualifies any representations made about the product,” and (ii) whether the risk information is presented with a “prominence and readability comparable to the benefit claims about the product.” While risk disclosures may be concise when paired with benefit information, a hyperlink to a complete, and exclusive, discussion of risks should be included and appropriately titled and not promotional in nature.
Both the proprietary and established (generic) name for the product should be included within the character-space limited communication and on each landing page associated with each hyperlink in that initial communication. Draft Guidance #2 recommends that the landing page be devoted exclusively to the communication of risk information about the product and not to the promotional home page. Such landing page should also prominently display quantitative ingredient and dosing information for prescription drugs.
In light of the restrictions set forth by Draft Guidance #2, while companies should feel comfortable taking advantage of current social media platforms including those with character restrictions, they should also ensure that the parties responsible for drafting any such posts are aware of the parameters placed on such communications. A hypothetical example provided by Draft Guidance #2 exemplifies some of the potential disadvantages of such messaging:
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk
While the message complies with each of Draft Guidance #2’s directives, the balancing of risk and benefit information in a space restricted communication may have the unintended result of highlighting risk over benefit. Additionally, from a practical standpoint, the space constraints may prevent the inclusion of all necessary information. If a company cannot conclude that “adequate” benefit and risk information (along with other required disclosure) may be communicated in the same message or tweet — particularly at 140 characters — Draft Guidance #2 recommends that the company reconsider whether the use of the particular platform is the appropriate forum for the dissemination of such messaging before making use of such forums, once again in particular for drugs with complex indications or high risk profiles.
As a general conclusion, while the Guidance on Presenting Risk/Benefit Information is self-admittedly limited in scope, and does not address “promotion via product websites, webpages on social networking platforms (e.g., [Facebook, Twitter, YouTube]), and online web banners,” it undeniably provides helpful direction for drug and device companies’ use of social media sites for promotional messaging where communications are restricted to a limited number of characters, as well as highlighting how the FDA may intend to regulate such use. Companies should pay careful attention to the restrictions while taking advantage of the opportunities these social media platforms offer, and should take care to ensure to instill clear policies that comply with Draft Guidance #2 that are available to, and understood by, individuals tasked with producing and monitoring social media content for the company.
The FDA will be accepting comments on both Draft Guidance #1 and Draft Guidance #2 until September 16, 2014. If you would like to discuss the issues presented, or any related matter, please contact any member of Mintz Levin’s Life Sciences team.
The authors acknowledge the assistance of Mintz Levin Summer Associate Nichole Beiner with the preparation of this alert.