iThe Food and Drug Administration (“FDA”) recently issued two draft guidance documents for the drug and medical device industries relating to challenges posed by the use of social media to convey product information.[1]
The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine advertisements) (the “Twitter Guidance”). With this proposed roadmap, drug and medical device companies would have clearer guidelines for using internet advertisement and social media platforms with character space limitations for product promotion.
The second draft guidance addresses how drug and medical device companies may appropriately respond to misinformation about the company’s products on the Internet or social media (the “Misinformation Guidance”). Under this draft guidance, so long as there is no promotional aspect to a company’s response to misinformation posted by an independent third party, satisfaction of all of the FDA’s advertising and promotional labeling requirements would not be required. With this guidance, drug and device companies would likely feel more comfortable engaging with consumers online to correct product misinformation.
The Twitter Guidance
Background on Promotional Labeling and Advertising
The FDA has oversight responsibility for the labeling and advertisement of drugs and medical devices. Drugs and devices will be misbranded if they do not satisfy the labeling and advertising requirements of Food, Drug and Cosmetic Act (“FDCA”) and FDA regulations.
Labeling has been interpreted expansively to mean essentially anything that describes the drug or medical device product, regardless of whether it is attached to the product. As noted in the draft guidance documents, the FDA generally recognizes two types of labeling: (1) FDA-required labeling (e.g., product labeling as part of a new drug application), and (2) promotional labeling. Promotional labeling is generally any labeling, other than the FDA-required labeling, that is devised for promotion of the product.
Requirements for Advertising and Promotion Using Character Space Limitation Platforms Under the Draft Guidance
Requirements.
The FDA draft guidance states that use of social media or Internet advertisements with character space limitations for product promotion would be acceptable under the following circumstances:
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Material Facts about Indications. To ensure that benefit information is accurate and not misleading,[2] material facts about use of the product should be disclosed (e.g., information about the relevant patient population or limitations to an indication).
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Balanced Benefits and Risks Presentation. Risk information must accompany the product’s benefit information in the same communication so as to qualify representations about the product’s benefits. For example, a company could not tweet a drug’s benefit information and then separately tweet the drug’s risk information. In addition, the benefits and risks must be presented in an equally prominent manner, and any formatting techniques used for benefit information should also be used to convey risk information, except that risk information should also be highlighted (e.g., in bold text).
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Risk Information Disclosure. The promotion or advertisement must include a concise disclosure of the most serious risks of the product. For drugs, this would include all risks from a boxed warning, all risks that are known to be fatal or life threatening, and all contraindications from the approved product labeling. If none of these apply, then the most significant warnings should be communicated. For devices, if a particular risk is associated with a particular identifiable use or population, then each such risk should be included.
This minimum risk disclosure should be supplemented by a mechanism (such as a hyperlink) to allow direct access to a more complete discussion of risks associated with the product.
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Drug or Device Name. Both the proprietary (trade or brand) name and the established name (if there is one) must appear on the character space limited promotion or advertisement as well as on the risk information hyperlink(s) provided, with the generic name listed directly to the right of, or directly below, the brand name. In addition, for drugs, in the landing page of the hyperlink, at least one dosage form and quantitative ingredient information should be displayed in direct conjunction with the brand and established names.
The draft guidance includes the following as an example of a promotion that could be used on Twitter:
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk
In this example, the brand and established names are communicated together; benefit information is presumably accurate, and the most serious risks associated with the drug are communicated together with the benefit information within the tweet; the risk information within the tweet is disclosed in a manner comparable to that of the benefit information; and direct hyperlink provides comprehensive risk information about the drug. In addition, the URL www.nofocus.com/risk (emphasis added) denotes that the landing page is composed of risk information, and the URL itself is not promotional in tone.
Caveat
As the FDA notes in the Twitter Guidance, for products with complex indications or extensive serious risks, it may not be possible to satisfy the FDA’s proposed requirements using a character space limited platform. This is especially true if there is a significant amount of material risk information that must be disclosed. However, a medical device or drug company would still have the option of using character space limited platform for permitted reminder promotions (i.e., labeling or advertising that calls attention to the name of a drug or device but does not include indications, dosage recommendations or other information). Reminder promotions are exempted by regulation from the promotional labeling and advertising requirements that require the disclosure of risk information.
Take-Away
While these draft guidelines (if finalized) may encourage life sciences companies to utilize social media for product promotion, there are some drawbacks, including the fact that safety information (which must be included) tends to be lengthy and not amenable to character space limitations. In addition, as recently noted by a Google spokesman for some social media sites, sitelinks (required for access to additional risk information under the guidance) aren’t guaranteed to appear. It is likely that industry stakeholders will address such practical hurdles during the ninety (90) day comment period for the draft guidance, which ends on September 16, 2014.
The Misinformation Guidance
Requirements for Responding to Misinformation Under the Draft Guidance
In the Misinformation Guidance, the FDA discusses how drug and device companies should respond—if they choose to respond—to misinformation related to the company’s FDA-approved and/or cleared product when that information is created or disseminated by independent third parties on the Internet (such as misinformation posted on social media). For purposes of the draft guidance, the FDA defines “misinformation” as positive or negative incorrect representations or implications about a company’s product that are created or disseminated by independent third parties who are not under the company’s control or influence and that are not produced by or on behalf of, or prompted by, the company. Thus, a company could not rely on the Misinformation Guidance when the company is responsible for or otherwise influences the product communication that contains the misinformation.
The draft guidance states that the FDA would not object if a drug or medical device company did not satisfy otherwise applicable regulatory requirements regarding labeling or advertising when it voluntarily corrects misinformation, so long as the correction of misinformation was done in a truthful and nonmisleading manner and in accordance with the draft guidance.
The draft guidance emphasizes that for any misinformation about a company’s products, the applicable drug or medical device company is not obligated to correct it, but if it chooses to do so, it would have to do so in conformance with the Misinformation Guidance. Under the draft guidance, the corrective information would have to:
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be relevant and responsive to the misinformation;
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be limited and tailored to the misinformation;
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be nonpromotional in nature, tone, and presentation;
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be accurate;
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be consistent with the FDA-required labeling for the product;
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be supported by sufficient evidence;
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either be posted in conjunction with the misinformation in the same area or forum of the source of the misinformation (if posted directly by the company), or reference the misinformation and be intended to be posted in conjunction with the misinformation (if the corrective information is provided to the owner or operator of the website);
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include a disclosure that the person providing the corrective information is affiliated with the applicable medical device or drug company; and
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include the FDA-required labeling for the product in a readily accessible format such a hyperlink that goes directly to the FDA-required labeling (but not a link to a promotional website).
Importantly, if a company’s response goes beyond the correction of misinformation (e.g., includes information that does not meet the criteria listed above) or fails to address the above requirements, then the corrective information would have to comply with the applicable regulatory requirements related to promotional labeling and advertising.
Take Aways
While the Misinformation Guidance may be a welcome development with public health benefits, there are questions that remain unanswered. For instance, the draft guidance states that the FDA will permit companies to correct only a clearly defined portion of a forum (e.g., a single comment on a blog as opposed to all comments on a blog) if it clearly identifies the misinformation it’s correcting, defines the portion of the forum it’s correcting, and corrects all of the misinformation that appears in that clearly defined portion. However, the FDA also states that if a company chooses to correct misinformation in several blog postings that provide incorrect risk information associated with the product and makes clear that it is only correcting those pieces of misinformation, but does not address exaggerated efficacy claims in favor of the firm’s product in other postings that appear to readers between the postings it is correcting, the firm’s actions would not be in accord with the guidance. Will the FDA find it problematic if a company corrects only forums that have only negative misinformation?
As is true of the Twitter Guidance, the Misinformation Guidance is also subject to a 90-day comment period ending on September 16, 2014, and should not be relied upon as final policy.
[1] “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Informationfor Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” both of which are available here. The slides from a recent FDA webinar on these draft guidances can also be viewed here.
[2] For example, the FDA recently issued an “untitled” letter to a drug company regarding a Google advertisement that misleadingly indicated that it could be used for “prevention” of a disease, while the drug is only approved for the “treatment” of the disease.
