Pharmas search for sense in FDA's 14 letters

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Drug and device companies are still digesting DDMAC's 14 untitled letters issued in March declaring sponsored links on search engines for 45 drugs to be in violation of agency rules.


"One week the agency puts out the message that 'it is the message, not the medium,' and the next week they act in exactly the opposite manner," quipped Mark Senak of Fleishman Hillard on his blog, EyeonFDA. 


There had been signs of a spring thaw in the agency's refusal to offer guidance specific to online media. In April, MM&M reported that DDMAC has tasked Jean-Ah Kang, a special assistant to director Tom Abrams, with developing policy on the use of Web 2.0 to communicate information about prescription drugs, and several drug company digital gurus are in touch with the division about their own efforts to develop ground rules for social media and online marketing. But the détente was soon eclipsed by the agency's confusing edict on sponsored links, which the letters deemed violative because they omitted risk information. How, marketers wondered, could they be expected to include risk information in the 96 characters allowed in a Google sponsored link? What did it matter when full risk information was displayed prominently on the pages linked to, and how was that any different from print ads where the reader has to turn the page to get to the brief summary? 


"DDMAC is asserting that the information available on the landing page is utterly irrelevant in determining if, in context, the entire 'advertisement' is or is not misleading on account of a failure to disclose risk information," said Arnie Friede of McDermott Will & Emery. "Unilateral rejection by DDMAC of the landing page as a component of the entire advertisement effectively misinterprets what is the 'advertisement' as a whole. It violates cardinal principles of advertising interpretation that FDA itself has routinely adopted in a variety of related contexts."


So much for the "one click rule," whereby companies figured they were OK as long as risk information was a click away. The agency said companies could get right with the law by running unbranded links or treating them as reminder ads, which may tout the name of a drug but not indications, dosage or safety or effectiveness. For 18 of the brands cited that carry boxed warnings, however, reminder ads are verboten. 


Rita Chappelle, of FDA communications, told The New York Times: "Our laws for how products that are approved by the agency can be marketed to consumers are the same regardless of the medium, whether they are print ads, radio ads, television ads or Internet ads."


Sponsored links for some of the brands have returned. Search Google for Plavix and you'll get one that reads: "Ask Your Doctor Why PLAVIX (clopidogrel bisulfate) May Be Right for You. Learn More." Many have not. Thanks to search engine optimization, brand sites almost always top organic searches, but must compete with Wikipedia, drug index sites and, in the right-hand tower of sponsored links, sites like CanadaPharmacy.com. 
"So FDA's position on sponsored links would have the perverse effect of making regulated information less available to information seekers, while making unregulated, and hence unvalidated, information more available as a consequence," said Friede. "There is something fundamentally wrong with that picture. It also implicates, in a myriad of as-yet undetermined ways, FDA's entire approach to the Internet medium." 


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