The Food & Drug Administration has issued an initial guidance for pharmaceutical companies and their marcomms partners containing standards for promoting FDA-approved or FDA-cleared products in space-constrained social media. The FDA has also recently provided guidance about how these pharmaceutical companies can correct online misinformation about their products.
The FDA invited comments to these draft guidelines, but that commons period ended two weeks ago. The draft guidelines, while not yet final, nonetheless provide useful information about the administration’s current thinking. As such, they serve as important developments for communications firms working with drug companies in social and digital media.
The FDA’s draft guidance explains that a company that chooses to present benefit information on Internet or social-media platforms with character space limitations must present risk information on these platforms that is "comparable in content and prominence" to the benefit claims. In addition, the drug company should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
Toward these ends, the draft guidance makes five specific points:
•Benefit information should be accurate, non-misleading, and should reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).
•Benefit information should be accompanied by risk information within each individual character-space-limited communication.
•The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product, such as all risks from a boxed warning (which should be in bolded text), all risks known to be fatal or life threatening, and all contraindications from the approved product labeling.
•A mechanism, such as a hyperlink, should be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product.
•The FDA does not intend to object to the use of URL-shortening services, although it recommends that the URL or Web address itself denote to the user that the landing page contains risk information (e.g., www.product.com/risk). Moreover, the FDA may take into consideration whether claims are false, misleading, or otherwise problematic based on a URL or Web address that itself is promotional in content or tone.
In addition, the FDA has stressed there also are other applicable legal requirements to the drug companies’ communications in social media. These include ensuring the use of the product’s established name and its trade or brand name, as well as the need to display the name of at least one specific dosage form.
Meeting all of these requirements "may pose challenges" to drug companies and their communications firms, as the FDA itself recognizes. In fact, an accurate and balanced presentation of both risks and benefits of a specific product may not be possible within the constraints of a particular platform. In such a case, a company would be best advised to reconsider using that platform for the intended promotional message.
The FDA’s guidance also applies to efforts by a pharmaceutical company – if it chooses to act – to correct independent third-party misinformation about its products on the Internet and social media platforms. Significantly, this applies regardless of whether that misinformation appears on the company’s own forum or on an independent third-party forum or website.
According to the FDA, the drug company may choose to provide appropriate truthful and non-misleading corrective information or, alternatively, may provide a reputable source from which to obtain the correct information, such as the firm’s contact information. The FDA advises, therefore, that FDA-required labeling should be included or provided in a readily accessible format (e.g., a link that goes directly to the FDA-required labeling or a link that opens a new window to a PDF file). It should not be provided, however, by including a link to a promotional website even if the information is available on that website.
The FDA, acknowledging that it may be difficult for a company to correct all misinformation about its products in one forum, stressed that a company that corrects one or more occurrences of misinformation is not expected to correct each piece of misinformation in an entire forum. The FDA’s guidance indicates, however, that a company should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and correct all the misinformation that appears in that clearly defined portion.
In its guidelines, the FDA has provided a number of approaches that can be used to correct misinformation, including:
•Correcting misinformation directly on the forum;
•Providing the corrective information to the independent author for him or her to incorporate;
•Requesting that the author remove the misinformation or allow comments to be posted; or
•Requesting that the site administrator remove the misinformation or allow comments to be posted.
Communications firms currently working with pharmaceutical companies, or hoping to do so, should make sure to keep abreast of developments in this area.
Michael Lasky is a senior partner at the law firm of Davis & Gilbert LLP, where he heads the PR practice group and co-chairs the litigation department. He can be reached at email@example.com.