Industry and public input needed for US Guidance on use of Internet in the promotion of FDA-regulated medicines, says official

Jean-Ah Kang, Special Assistant to Director Tom Abrams at the US Food and Drug Administration's Division of Drug Marketing, Advertising and Communications (DDMAC), recently re-stated and emphasized that the FDA is requesting additional information from the public, including pharmaceutical companies and other health organizations, to help the agency determine whether explicit Internet-specific guidance should be drafted, and if so, what considerations should be made.

Her comments came in an exclusive interview with Fabio Gratton, chief innovation officer at Ignite Health, and marks the first time the FDA has spoken publicly on this topic since the two-day public hearings held last November, during which the FDA heard 77 presentations from pharmaceutical companies, communication agencies, consultants, research firms, search engine companies, trade organizations, and non-profit groups on the topic "Promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools."

Following the hearings, as the next step in what the FDA calls "Good Guidance Practices," the FDA requested that additional supporting data and comments be submitted to the Division of Dockets Management by February 28, 2010. To date, the public docket has 14 comments.