April 11, 2011 – While waiting for the Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) to begin issuing social media guidance, it is important for agencies and clients to create compelling sites for professionals and patients that stay within the FDA’s existing policies, according to John Kamp, executive director of the Coalition for Healthcare Communication. “Whenever the FDA starts issuing the guidelines, they will be important, but not dramatically change the landscape,” Kamp said.

Kamp made these observations this week to a group of agency heads, in light of the recent announcement by the FDA that it missed the April 1 deadline for its first draft of social media guidelines. “There is no reason to wait for the guidance. DDMAC head Tom Abrams repeatedly has made it clear that the new guidelines will not include new Internet and social media marketing policy,” said Kamp. “Doctors and patients are using the Internet at increasing rates. If we want to remain relevant, we must participate and do so within the existing rules.”

The agency’s statement about the guidelines’ delayed release said that although “policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities,” it could not give a new target date for the guidelines.

In the interim, industry should follow existing regulations and policies. DDMAC’s Abrams advised pharma companies at a DIA meeting earlier this year that the forthcoming guidelines will address specific social media matters, but in general, “there will be no new regulations or new standards.”

“Look at our recent Warning Letters involving social media, such as Facebook,” Abrams said. “These Warning Letters cite existing rules and do not make new policy.”

Kamp similarly counsels industry to follow current rules and policies until DDMAC issues formal guidance. “Companies already know the 10 Commandments of DDMAC. There likely won’t be any huge surprises when Moses descends from the mount,” he said. 

However, this reality may create tough choices for clients, Kamp indicated. For example, many companies only host social media sites about relevant disease states and avoid branded drug sites. “Branded sites are a problem because company-moderated discussions must stay on label. This confuses and sometimes angers site visitors because they don’t understand the FDA constraints,” he said.

DDMAC’s recent statement explained that it is considering both internal and external input as it develops guidelines, including testimony and comments from last year’s Part 15 hearing, and has identified the following issues it believes should be addressed in social media guidelines:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• On-line communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation

The statement also suggested that DDMAC will be developing multiple draft guidance documents to address these topics.

In response to DDMAC’s statement, the Pharmaceutical Research and Manufacturers of America (PhRMA) reiterated that social media outlets are important outreach tools for the industry. “There are incredible potential public health benefits to using electronic media in healthcare, including allowing innovative companies to provide truthful, scientifically accurate FDA-regulated information,” according to PhRMA Assistant General Counsel Jeffrey K. Francer.

Kamp applauded the PhRMA proposal, saying that it would establish a responsible mechanism for providing safety information in space-restricted media. For example, PhRMA proposed allowing the use of a universal symbol alerting patients of Web sites that feature FDA-regulated benefit and risk information. “Internet users understand that Web information can be suspect,” Kamp added. “The PhRMA proposal would point to reliable information vetted by the FDA.”