As mentioned in our previous post, earlier this week, the Food and Drug Administration (FDA) released two draft guidance documents for industry that offer “recommendations” regarding how pharmaceutical and medical device manufacturers can use Internet and social media platforms to (1) correct independent third party misinformation about prescription drugs and medical devices; and (2) present risk and benefit information where there are character space limitations (e.g., Twitter). Our previous blog post addressed the former, while this post focuses on the latter.

The second draft guidance, entitled “Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” provides recommendations regarding the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the sponsored search results links on Google,  Yahoo, etc..  While FDA recognized the “challenging” nature of communicating in such media, the Agency maintained that “benefit claims in product promotions should be balanced with risk information” “no matter the Internet source used,” and recommended that companies provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products, such as a hyperlink.

The draft guidance is not applicable to promotion via product websites, webpages on social media networking platforms (e.g., individual product pages on websites such as Facebook, Twitter, YouTube), and online web banners because they do not impose character space constraints.  Nor does the draft guidance apply to reminder promotions that are exempted by regulation from the requirements under the FDCA for the disclosure of risk information.

FDA offers three points to consider when communicating benefit information on Internet/social media platforms with character space limitations:

  1. (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. (2) benefit information should be accompanied by risk information within each individual character-space-limited communication; and
  3. (3) if a manufacturer 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 manufacturer should reconsider using that platform for the intended promotional message.

Similarly, FDA offers several points to consider when communicating risk information:  (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; (3) a mechanism, such as a hyperlink, should also be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product; and (4) the prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.

FDA explained that at “a minimum,” manufacturers “should communicate the most serious risks associated with the product together with the benefit information within the individual character-space-limited communication,” which for drugs generally include risks in boxed warnings, risks known to be fatal or life-threatening, and all contraindications from the Prescribing Information.  With respect to the mechanism, FDA recommended that the hyperlink destination (i.e., landing page) be “devoted exclusively to the communication of risk information about the product.”

As we mentioned in our previous post, while helpful in calibrating company practices, ultimately, the new draft guidance documents do not break significant new ground, and largely adhere to FDA’s past thinking on these issues.  While the guidance documents are non-binding, FDA may now decide to step up enforcement, so companies must carefully consider their internal policies and employee handbooks in light of the Agency’s positioning on these issues.