The FDA shouldn't hold off on issuing guidance on drug marketing and online or social media, said The Advertising Coalition in comments submitted to the agency.
The FDA's Division of Drug Marketing, Advertising and Communication in April announced several studies
looking into how the presentation of risk and benefit information in brand.com sites can affect consumer comprehension. The Advertising Coalition's comments were submitted under an open comment period for the studies. The studies seemed likely to push back long-promised and oft-delayed
guidance on the topic, though DDMAC director Tom Abrams said recently the agency would move forward regardless.
Guidance on Internet marketing, the trade group said, is too important to wait until the studies are completed.
“In the absence of definitive guidance on the subject from FDA, what we are left with, then, is regulation of DTC Internet promotion through ad hoc agency enforcement actions,” said Advertising Coalition executive director Jim Davidson in his comments, citing the 14 notices of violation issued by the agency in April, 2009 to drug and device firms using sponsored links.
Legalizing the use of “conspicuous hyperlinks” to risk information in lieu of the full fair balance is a particular concern for the Advertising Coalition, which argues that “Guidance by the agency on this point alone would remove a substantial and needless barrier to the use of new media that is often constrained by space limitations on the maximum content that can be displayed at any single moment in time in a given promotional execution.” FDA, the group said, should place hyperlinked risk information in context of a “net impression” rather than banning it outright.
And the Advertising Coalition expressed concern that the proposed studies fail to consider “multiple executional elements simultaneously at play in Internet drug promotion.”
“Online prescription drug advertising does not exist in a vacuum,” wrote Davidson. “It must be assessed in the context of the online health information-seeking behavior that is by now a familiar part of our everyday lives. Information about risks and benefits from individual prescription drug therapy is available from multiple online and other sources and there is no reason to believe that a patient's understanding of these is influenced solely and exclusively by what is said or not said in an individual advertising execution.”