As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of the FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research acknowledged in a recent FDA blog post that in addition to traditional sources of medical product information, patients and healthcare providers are also obtaining information through social media and other internet sources. In response to this growing trend, the FDA issued two draft guidance documents in June that seek to establish some ground rules for prescription-drug and medical-device manufacturers (firms) seeking to present information about products via social media.

The first draft guidance document, titled “Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” provides recommendations to firms concerning the presentation of risk and benefit information about their products on internet/social media platforms with character-space limitations.^[1] The scope of this guidance pertains to:

• Online microblog messaging (e.g., Twitter)
• Online paid search (e.g., Google/Yahoo “sponsored links”)
• Future character-space-limited Internet/social media platforms (long-term applicability)

The draft guidance does not apply to:

• Product websites
• Webpages on social media networking platforms (e.g., individual product webpages on Facebook, Twitter, YouTube)
• Online web banners
• Responsive web design or other technology-specific presentations (e.g., mobile devices, tablets)

The FDA provided an example Twitter post meeting all of its requirements: “NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk.” The post uses 134 characters out of Twitter’s immutable 140-character limit, but still includes the following:

• The brand/trade/generic name and established name displayed together
• The indicated use of the product
• The active ingredient
• An equal amount of both benefit and risk information, displayed so both are equally readable, clear and prominent
• A hyperlink to more detailed, thorough information on risks
  • The FDA recommends that hyperlinked landing pages—in addition to featuring risk information—show the brand and established name together with dosage form: “NoFocus (rememberine hydrochloride) 200mg Capsules”

The FDA guidance recommends that every character-space-limited post communicating product information disclose the above-listed information. The only exception is for “reminder” promotions—promotional advertisements that call attention to the name of the product but make no suggestions or claims about it.

By this draft guidance, the FDA does not intend to object to the following: communicating the established name of a product directly to the right of, or directly below, the proprietary name within the character-space-limited communication; substituting commonly recognized linguistic symbols for words; using punctuation marks to help with the presentation of information; or denoting a chemical ingredient name with a scientific abbreviation.

The guidance stresses that every post, other than “reminder” promotions, must present truthful, accurate information and that there be a fair balance between risk and benefit information. The FDA advises that, at minimum, firms include the most serious risks in their posts.

In considering the use of this forum, the FDA also recommends that firms carefully consider the complexity of the indication and risk profiles for each of their products to determine whether a character-space-limited platform will enable meaningful presentations of both benefit and risk information. The FDA expects that many firms will not be able to both present sufficient information and meet the character-space limit, especially for riskier products. In these cases, according to the guidance, firms should “reconsider using that platform” altogether. 

The full draft guidance document is available here.

Comments on the draft are due September 16, 2014, and may be made via processes described here.

Notes:

^[1] We will address the second guidance document, which details when and how firms may respond to third parties who post misinformation about products on internet forums, in a subsequent Health Law Checkup.