Public Hearing on Promotion via the Internet

Christian Didizian, CIS Compliance Manager
chrisdidizian@cis-partners.com

Back on June 4th I posted a blog article entitled New Draft Guidance on Presentation of Risk Information, highlighting the FDA draft guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion. To summarize that entry, I acknowledge that while the guidance was long overdue, it neglected to address issues surrounding promotion through the internet. On September 21st, the FDA announced that these issues would be discussed in a public hearing regarding the promotion of regulated products through the Internet and other methods of DTC advertising/promotion. The hearing will be held on November 12th and 13th from 8 AM to 5 PM. Registration for this hearing is due by October 9, 2009.

This meeting will aid the FDA in forming policy on promoting these products to ensure that all concerns and issues are addressed. The Agency is particularly interested in how “Web 2.0” can be used to promote products in a truthful, non-misleading, and balanced manner to both consumers and health care professionals (Federal Register 74:181). Web 2.0 includes new web development and design that facilitates interactive information sharing. Additionally, the FDA is particularly interested in “emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis” (Federal Register 74:181). I encourage anyone interested in this hearing to read the full announcement by clicking here.