Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules governing drug promotion to today’s world of internet communications and social messaging. Now, a guidance from the agency’s Office of Prescription Drug Promotion (OPDP) —and its counterparts for biologics and animal drugs — outlines agency preferences for how marketers should monitor and provide information of its online communications activities.
This first of what promises to be a series of guidances on this subject describes what kind of internet communications material marketers have to submit to FDA, and how and when they should do so. The main thrust of the January draft guidance is that marketers don’t need to obtain FDA preclearance on planned tweets or online postings before they’re sent out — a reasonable approach, as extending prior submission standards to interactive media essentially would rule out pharma internet communications. But FDA does want companies to submit information on initial use of both its own sites and those it influences, and to provide monthly updates on active communications. This would apply to blogs, microblogs like twitter, social networking sites, live podcasts and other interactive messaging.
The guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (available at www.fda.gov) explains that FDA wants to see the layout and content of interactive media sites that are owned, controlled, created or operated by regulated firms. It’s not clear how much marketer control will warrant reporting, but OPDP is looking to include materials posted to social media sites that are operated by third parties if the pharma company has any influence on its operations. FDA says it will exercise its “enforcement discretion” about requiring complete submission of all postmarketing interactive communications activities.
FDA faces a July 2014 deadline for publishing guidance on internet promotion of medical products, and more pronouncements are on the way: Messages using limited space and internet links are hot issues. If this first guidance is a model, FDA plans to maintain the premise that drug manufacturers are responsible for online promotion of their products, including communications by employees and agents, and that firms have to keep it informed of who is saying what, on the internet as with traditional media.