CDER’s Office of Prescription Drug Promotion (OPDP) has decided to issue five separate guidance documents that will address “social media” issues that have arisen in advertising and promotion areas. “We decided not to issue just one guidance because it would be burdensome and changing all the time,” OPDP director Tom Abrams told a Drug Industry Association conference in Philadelphia 6/25. ”Instead, guidance will be developed on policy-specific issues and not on any specific technology platform. We don't know what the platforms will be in two years. We know Facebook, Twitter, and Youtube are very popular now, but we don't know how they will evolve or what new platforms will be available next year...So to try to have a guidance based on one platform, such as Facebook, would be a mistake and quickly outdated. And we are developing guidance applicable to whatever platform companies my use for prescription drug promotion.”
A guidance under development is on Fulfilling Regulatory Requirements When Using Tools Associated with Space Limitations, which will address how to include risk information when there is a character limitation such as Twitter, Abrams said.
A guidance on Fulfilling Post-marketing Submission Reporting Requirements is under development to address how to submit promotional material at the time of initial use when engaging patients and others in chat rooms, Abrams told the conference. Other guidances will touch on the appropriate use of hyperlinks, and the best practices for correcting misinformation on third-party Web sites.
Without providing any specific timeline for issuance, Abrams said OPDP has assigned substantial resources to the guidance development and other areas, like the Office of Chief Counsel, are also helping with their drafts.