The FDA has issued the following two guidance documents:
- Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
- Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
Short-form Digital Media
The first FDA guidance summary emphasizes that no matter the limited digital space, sp
This guidance provides direction regarding branded tweets and online ads. It also counsels that for certain complex indications, digital media may be the wrong channel. This FDA guidance reminds companies that for long-form digital channels current FDA guidelines still apply. The guidance providesonsors must provide the product benefits and main risks in the same message or tweet, with a link to detailed risk information. Regarding paid search, FDA directs companies how to use links within ads that satisfy fair balance requirements.
In order to align with this guidance it will be prudent for companies to audit their twitter, online paid ad, and other “short form” digital communication messages to ensure they are compliant.
Correcting Online Misinformation
The second FDA guidance explains how companies may choose to correct online “misinformation” about their products. Misinformation is defined as positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular.
If a firm voluntarily chooses to correct misinformation, a firm’s communication should:
- Be relevant and responsive to the misinformation;
- Be limited and tailored to the misinformation;
- Be non-promotional in nature, tone, and presentation;
- Be accurate;
- Be consistent with the FDA-required labeling for the product;
- Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
- Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
- Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.
Also, if a company elects to correct misinformation it is not required to communicate that is was corrected. Further, the company does not need to submit any correct action to the FDA but is encouraged to keep detailed files of the correction process. Adverse event reports should be reported under the current regulatory guidelines.
Best Next Steps
These guidance documents represent an opportunity to analyze the online landscape for misinformation about your product – prioritizing larger websites. These documents also suggest that firms should establish processes to correct misinformation and educate and train employees regarding these processes.
An open dialogue between management, legal, medical, sales and marketing will enable strong adherence and compliance to new FDA social media guidance recommendations.
JFK Communications provides a variety of services designed to listen, monitor and measure online content. Our expertise in inbound marketing, optimized content development, SEO and online ROI metrics, makes us an ideal partner to help life sciences firms engage patients, partners and customers via digital media channels.
Challenge us here:
These FDA guidance documents are draft and the FDA is encouraging commentary.
Interested parties are encouraged to submit comments here: http://www.regulations.gov.