The FDA provides guidance for pharmaceutical and medical device manufacturers as to how to present risk and benefit information for their medical devices and products on social media. FDA’s first draft guidance, entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” permits companies voluntarily to correct third-party misinformation related to their own products and provides recommendations about how to provide such corrections.
This refers to situations where third parties who are not under the manufacturer’s control or influence, disseminate incorrect information about the medical device or product.
Generally, FDA recommends that the medical device or pharmaceutical manufacturer provide corrective information that is:
- relevant, accurate, responsive, limited and tailored to the misinformation;
- be non-promotional in nature, tone and presentation;
- be supported by sufficient evidence; and
- disclose that the person providing the correction is affiliated with the manufacturer.
FDA recommends that the corrective communication include the FDA-required labeling or a hyperlink to such information, and that the corrective information be posted in conjunction with the misinformation (e.g., same area or forum).
Although FDA guidance documents such as the guidance document on Social Media Misinformation are not binding, they do indicate enforcement priorities.
The second draft guidance, entitled “Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical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 FDA-regulated medical products (such as prescription drugs or medical devices), using Internet/social media sources with character space limitations, such as Twitter and the sponsored search results links on sites such as Google or Yahoo.
The draft guidance is not applicable to promotion via product websites, webpages on social media networking platforms (e.g., individual product pages on websites such as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 Nor does the draft guidance apply to reminder promotions that are exempted by regulation from the requirements under the FDCA for the disclosure of risk information.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’s guidance begins by reminding companies that the federal Food, Drug, and Cosmetic Act gives FDA oversight of labeling of drugs and medical devices, and that labeling includes the product website as well as product advertising.
Further, FDA can consider a medical device or drug to be misbranded if the labeling or advertising is misleading.
- Risk information should be comparable in content and prominence to benefit claims within the product promotion (i.e. a balanced presentation).
- Regardless of the platform, truthful, accurate, non-misleading, and balanced product promotion is best.
FDA recommends that:
- 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).
For example, labeling for an approved premarket approval application (PMA) for class III medical devices or use information consistent with a cleared intended use for 510(k) medical devices provides the basis for the benefit information related to the device. Such information should include material facts that the company should present in the communication.
- Benefit information should be accompanied by risk information within each individual character-space-limited communication.
- 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.
FDA provides some illustrative examples such as a product called “headhurtz” for severe headache from traumatic brain injury.
FDA provides factors to consider in reviewing whether risk information is comparable to benefit information:
1. Whether the risk information qualifies any representations made about the product’s benefits
2. Whether the risk information is presented with comparable prominence and readability
In communicating risk information on social media platforms with character space limitations, companies should consider:
(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.
(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.
At minimum, a medical device or drug company should communicate the most serious risks associated with the product.
FDA gives this example: “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder. Www.nofocus.com/risk.”
Remember that FTC as well as FDA concerns apply to advertising, marketing, and promotion of any medical device, drug, cosmetic, or dietary supplement. For any legal and regulatory issues relating to your medical device or medical product, contact our FDA and FTC legal team.