Life Science Compliance Update

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June 18, 2014

FDA Social Media Guidance: Presenting Risks and Benefits With Social Media’s Character Space Limitations

The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate online through social media. In the first of its new guidances, entitled "Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices," FDA provides recommendations for the presentation of risk and benefit information for drugs or devices using Internet and social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. FDA also offers some clarity regarding use of scientific abbreviations and recognized symbols to address the character space constraints.

Thomas Abrams Director, Office of Prescription Drug Promotion (OPDP) noted that the guidance comes two weeks before the July 2014 goal date set by congress for completion of the social media guidelines. Abrams recently released a blog post about the guidances.

Background

FDA tightly regulates pharmaceutical advertising, and currently companies are required to submit to the FDA every promotional document—including printed, television, and website advertisements—at the "time of initial dissemination." Companies must submit promotional activity for a particular drug product on Form FDA-2253. Furthermore, each ad must contain a variety of elements, such as cited evidence for all claims, a "fair balance" of the benefits and risks of the drug, and any Black Box warnings.

With the rapid increase of promotion through real-time social media outlets, pharmaceutical and device companies have wondered how to properly follow the regulations in the digital age. Promotions via tweet or Facebook post, for example, can be uploaded instantly, in large quantities, and, on Twitter at least, in a maximum 140 characters. Many stakeholders worried that the FDA would require companies to submit "interactive promotional material" as if it were a traditional printed advertisement. Should a company have to submit risk information for every tweet or LinkedIn message it sends out?

In light of the confusion surrounding space limitations, FDA's new guidance seeks to offer some black and white recommendations.

FDA Guidance on Character Space Limitations

FDA's Guidance covers the following Internet/social media platforms with character space limitations include online microblog messaging:

  • Messages on Twitter or "tweets," which are currently limited to 140 character spaces per tweet
  • Online paid search (e.g., "sponsored links" on search engines such as Google and Yahoo, which have limited character spaces as well as other platform-imposed considerations).

It does not address:

  • Promotion via product websites
  • Webpages on social media networking platforms (e.g., individual product pages on websites such as Facebook, Twitter, YouTube)
  • Online web banners.

Under the Food Drug and Cosmetic (FD&C) Act and FDA's implementing regulations, promotional labeling for drugs and devices and advertisements for prescription drugs and restricted devices misbrand the product if they make representations about the use of a firm's product without disclosing certain information about the product's risk.

In the latest guidance, FDA provides a crash course on misbranding that firms "should consider" when using Internet/social media platforms with character space limitations for product promotion:

  • Any promotional labeling for a drug or device must be truthful and non-misleading;
  • Any promotional labeling that makes claims about a firm's prescription drug or prescription device must include the indicated use of the product and the risks associated with use of the product;
  • Information required to appear on the label must be placed prominently with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
  • Prescription drug advertisements must present a fair balance between information relating to risk and information relating to benefit. In addition, risk information must be presented with a prominence and readability reasonably comparable to claims about drug benefits;
  • Prescription drug advertisements must contain risk information in each part, as necessary, to qualify any representations and/or suggestions made in that part about the drug. The risk information may be concise if supplemented by a prominent reference to the presence and location elsewhere in the advertisement of a more complete discussion;
  • In determining whether a drug or device is misbranded because its labeling or advertising is misleading, it must be considered whether the labeling or advertising fails to reveal facts that are material with respect to possible consequences of the use of the product as represented in the labeling or advertising or under conditions of use that are customary or usual;
  • FDA notes that character limitations may allow sufficient room for "reminder" promotions— labeling or advertising that calls attention to the name of a drug or device but does not include indications, dosage recommendations, or other information, that are exempted by the FD&C.

Thomas Abrams noted in his description of the guidance: "We understand that communicating on electronic Internet sites with character space limitations can be challenging. But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products." This guidance does not stray far from established promotion principles that companies are already very familiar with.

General Factors Considered in the Communication of Benefit Information on Internet/Social Media Platforms with Character Space Limits

  1. Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).
  2. Benefit information should be accompanied by risk information within each individual character-space-limited communication. Firms must consider whether enough capacity will remain in the character-space-limited communication to adequately convey certain other required information.
  3. If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message. The FDA uses an example tweet: "NoFocus for mild to moderate memory loss," uses 40/140 characters. This tweet is accurate and non-misleading and includes material facts about the indications and limitations of the drug "NoFocus." FDA states: The firm should consider whether the remaining 100 character spaces are enough to include risk information and certain other required information, as applicable." If not, "the firm should reconsider using Twitter for the intended promotional message for NoFocus."

Factors considered in the Disclosure of Risk Information

FDA notes that the Agency considers two primary factors to determine whether risk information is comparable in scope to benefit information within promotional materials: (1) whether the risk information qualifies any representations made about the product (i.e., content of the risk information compared to content of the benefit information) and (2) whether the risk information is presented with a prominence and readability comparable to the benefit claims about the product.

But FDA did acknowledge that this could be a challenge with character constraints. FDA noted that a "concise disclosure of specific risk information may be presented together with benefit information within the confines of character-space-limited Internet/social media platforms if supplemented by a prominent reference to the presence and location elsewhere of a more complete discussion of the risks associated with the product (or for restricted-device advertising, a "brief statement" of intended use and relevant risk information) and that this is consistent with requirements of the FD&C Act and FDA's implementing regulations."

FDA offered four points regarding risk information within character space limits:

  1. Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet).
  2. 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. For a prescription human drug, FDA noted the most serious risks would generally include all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling (the PI). For devices, FDA notes that risks associated with a particular identifiable use or population should be included.
  3. A mechanism, such as hyperlink, should also be provided to allow direct access to a complete discussion of risk. Twitter allows for shortening of links to fit within the character limits.
  4. The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication.

    FDA continued its NoFocus example for a full tweet:

    NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk [117/140]

Other Legal Considerations beyond Risk/Benefit

In addition to including both benefit and risk information within a character-space-limited communication, FDA states that there may be other applicable legal requirements to consider:

  • The established name must accompany the trade or brand name in labeling and in prescription drug and restricted-device advertising. Drug regulations specifically require that the established name be in direct conjunction with the proprietary name.
  • The drug regulations also stipulate that advertisements shall prominently display the name of at least one specific dosage form and have the quantitative ingredient information required by the FD&C Act in direct conjunction with such display. If other dosage forms are listed in the advertisement, the quantitative ingredient information for such dosage forms shall appear in direct conjunction and in equal prominence with the most prominent listing of the names of such dosage forms.

However, FDA noted that they do "not intend to object where the following approaches are used":

  • Firms should communicate both the proprietary (trade or brand) name and established name (for drugs, often referred to as the generic name) within the character-space-limited communication. The generic name of the product should be listed directly to the right of, or directly below, the brand name.
  • On the landing page associated with each hyperlink provided in the character-space-limited communication, firms should again communicate both the brand and established names as recommended in the preceding bullet. In addition, for prescription drugs, firms should prominently display at least one dosage form and quantitative ingredient information in direct conjunction with the brand and established names.

In addition, the Agency believes that common abbreviations (including scientific and medical abbreviations), punctuations marks, and other symbols may reasonably be used to help with character space constraints. The following examples illustrate instances where FDA does not intend to object to such usage:

  • Commonly recognized linguistic symbols may be substituted for words. For example, the ampersand symbol (&) may be used in place of the word and.
  • Punctuation marks may be used to help with the presentation of information. For example, dashes may be used to help separate benefit and risk information.
  • A scientific abbreviation may be used to denote a chemical ingredient name (e.g., "HCl" for hydrochloride; "HBr" for hydrobromide).

    FDA offered a Twitter example:

    "NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]"

Analysis

While this guidance does provide some clarity regarding FDA's expectations about companies' character limited promotions, the Guidance will prohibit many companies from using social media. Communicating the brand name and scientific name, benefits, risks, and a hyperlink is perhaps unreasonable within 140 characters, despite FDA's examples. This guidance will only be useful if your product has very limited side effects such as drugs that have gone OTC.  If you have serious adverse side effects than you will more than likely have to pass on limited charater social media.  We will be interested to see whether companies are able to navigate FDA's guidance and meaningfully utilize social media to inform patients about their products.

First Amendment Critique:

In our coverage of FDA's reprint guidance, we noted stakeholders were upset that FDA "omit[ted] any reference to the First Amendment." Likewise, in the social media guidance, John Kamp, of the Coalition for Healthcare Communication, noted that "despite assurances by senior FDA officials to address the serious First Amendment challenges raised by recent court decisions, the draft guidances contain no reference to the First Amendment and no careful analysis of any of the proposed restrictions using the factors outlined in the Supreme Court's Central Hudson test for commercial speech restrictions. These omissions could well come back to haunt the FDA if these restrictions are challenged in court."

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