Today, CEI filed comments (link to PDF format) on a draft FDA guidance document advising prescription drug manufacturers on how to comply with regulations requiring the presentation of risk information in drug and medical device advertisements. Although we disagree in principle with the current regulatory regime that requires almost encyclopedic presentation of risk information any time a manufacturer communicates the name of a drug and any mention of benefits in promotional materials, these comments focused on the FDA’s failure to treat the Internet and other new media as unique forms of communication that permit advertisers to present complete risk and benefit information in novel ways.
For example, in April, the FDA sent Notices of Violation to 14 drug manufacturers, informing them that their use of “sponsored links” to advertise prescription drugs on search engines such as Google were unlawful because the 70-character links did not present the same complete risk information required in conventional print advertisements. But, due to constraints of the medium, sponsored links cannot accommodate all the required information, which in any event is accessible “one click” away on the landing page of the URL to which the sponsored link directs the searcher.
Ironically, the draft guidance document goes to great lengths to explain that FDA will examine the overall context of an ad’s presentation of information and the ‘net impression’ that reasonable consumers would get from an ad in order to ensure that the risk information is displayed in the appropriate way. But, reasonable consumers don’t stop reading when they get search engine results. Finding the landing page, where they’ll see the complete information FDA requires, is precisely what an Internet key word search is all about. Consequently, we urged FDA reconsider this 1960s approach to drug ad regulation and bring its regime into the 21st Century.