The special assistant to the director of the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC), Jean-Ah Kang, told MM&M magazine that the FDA plans to answer questions related to the online promotion of drugs and devices this year. Kang said to expect FDA guidance regarding such questions as what to do with the proliferation of social media.
According to Kang, “Guidances are meant to reflect the agency’s current thinking. It’s one way to elaborate more on a topic because sometimes there are questions. Obviously our regulations did not anticipate YouTube and Twitter.”
MM&M explains that the guidance will address the following four topics:
1. For what are online communications companies accountable?
2. How can companies fulfill regulatory requirements, such as fair balance and risk information disclosure in space-limited media, such as search ads or Twitter posts, and tools that allow for real-time communications?
3. What parameters apply to the posting or corrective information on third-party Web sites?
4. When is the use of links appropriate?
The guidance will not, however, address the online reporting of side effects or AEs, which is under the jurisdiction of another office at the agency. Of course, this guidance will certainly hope to clarify what should and should not be done by companies online and thus expand the opportunities to use online and social media in the most effective and appropriate way.
