The start of the new harsher FDA
From John Mack's pharma blog forum comes this disturbing post: http://www.forums.pharma-mkting.com/showthread.php?t=19701
By on Aug 25, 2009From John Mack's pharma blog forum comes this disturbing post: http://www.forums.pharma-mkting.com/showthread.php?t=19701
This Warning Letter contains some of the harshest characterizations of a companys behavior in recent Warning Letter memory. In the Warning Letter, DDMAC Director Tom Abrams says, among other things, about the claim in question: This claim is a complete misrepresentation of the results of the Draelos study. (Bold in Original); [T]he journal ad grossly overstates the efficacy of the drug . . . (Bold in original). Even without considering the underlying merits of Director Abrams allegations, it would not be surprising, in light of recent actions in cases such as Bayers YAZ advertising where they almost immediately piggybacked onto an FDA Warning Letter, if the State AGs opened an investigation. While in the case of the YAZ Warning Letter, Bayer was subject to a pre-existing consent agreement with a number of states that governed going-forward advertising behavior, which helped provide a foundation for the State AGs ensuing action to follow-on the FDA Warning Letter, the probable absence of such a pre-existing order against Allergan would hardly be dispositive of the question whether the State AGs will be interested in piggybacking onto this Warning Letter. The enforcement principle the State AGs might wish to reiterate, i.e. that getting a Warning Letter from DDMAC incurs risks that go well beyond simply getting a letter from FDA, is fully operative here. Hence companies may wish to proceed even more cautiously now than before. Of course, there also remains the prospect for the inevitable consumer fraud litigation that might also ensue as a consequence of the Warning Letter.
Link to WL: http://www.fda.gov/Drugs/GuidanceCom.../ucm055773.htm
Does this mea that more and more DTC marketers are going to go into hide mode with DTC? You bet it does at a time when most consumers don't trust pharma ads and when more people are surfing the Internet for health information than are asking doctors about health.