Comments on the FDA’s Draft Guidance for Industry, Presenting Risk Information In Prescription Drug and Medical Device Promotion

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The Competitive Enterprise Institute today urged the U.S. Food and Drug Administration to reconsider the way it regulates prescription drug advertising on the Internet.  In comments on an FDA draft guidance document for drug industry advertising, CEI challenged the agency to bring its “1960s approach to prescription drug advertising and promotion into the 21st Century” by acknowledging that the Internet and other new media permit advertisers to present complete risk and benefit information in unique ways.

“The way advertising appears on the Internet is very different from traditional print advertising,” said Gregory Conko, CEI Senior Fellow.  “So, requiring Internet advertising to comply with rules drafted for newspaper and magazine ads is absurd when consumers know that risk information is just one click away.”

In April 2009, the FDA informed drug manufacturers that their use of “sponsored links” on search engines such as Google were unlawful because the 70-character links did not present the same encyclopedic risk information required of 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.

“FDA purports to examine the ‘net impression’ that reasonable consumers would get from an ad,” said Conko.  “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.”