In its August 2009 blizzard of compliance correspondence, DDMAC used some of the harshest language in recent Warning Letter memory to send what can only be interpreted as a message that its patience is wearing thin.
In a Warning Letter to Allergan about a journal ad for Aczone, DDMAC concluded that the ostensibly study-based claim that the product “works fast” to achieve a “24% reduction in inflammatory lesions at two weeks” is “a complete misrepresentation of the results of the Draelos study.” DDMAC was also troubled by the omission of the placebo response rate from a claim of effectiveness at 12 weeks: “The journal ad grossly overstates the efficacy of the drug by presenting only the most favorable result for ACZONE [48% reduction in inflammatory lesions] and ignoring the placebo response [42% reduction in inflammatory lesions].”
While the letter to Allergan was perhaps the most scathing, others from August contain their own pithy descriptions of the alleged violations. In a Notice of Violation to J&J on Ertaczo, and while acknowledging what it described as the drug's “modest effectiveness” against athlete's foot, DDMAC nevertheless concluded that the clinical study results “clearly do not support the claims that Ertaczo ‘wipes out' or crushes, kills and destroys tinea infections.”
Characterizations such as these, whatever their underlying merit, reflect increasing frustration with marketers and suggest that FDA might weigh additional enforcement approaches. FDA has sought disgorgement of profits and consumer restitution in at least one case—that of dietary supplement-maker Lane Labs—and its authority to do so was upheld by a federal appeals court. Similarly, FDA's approach to enforcement of good manufacturing practice requirements, including requests for injunctive relief and even appointment of a monitor, seems like another possible enforcement tool.
Nor are allegations like these by DDMAC likely to escape the attention of State Attorneys General and the private class action bar, potent enforcers in their own right. State AGs recently piggybacked on a Warning Letter issued to Bayer for Yaz DTC. The ensuing settlement required $20 million worth of corrective advertising – apparently commensurate with the original ad spend. Such court-ordered corrective advertising, agreed to “voluntarily” in order to resolve a State AG investigation, effectively bypasses the serious question of whether FDA itself has the authority to mandate corrective advertising, a now-familiar (yet judicially untested) component of every FDA Warning Letter.
All of this, coupled with new Commissioner Hamburg's heightened focus on Warning Letter enforcement and FDA's recently issued draft guidance, suggests that pharmaceutical marketers and medical ad agencies take heed. Now is the time for proactive approaches, implemented early in the creative process, to identify issues that might be raised by regulators and address them. This doesn't necessarily mean more tepid, less compelling communications. On the contrary, it suggests that marketers, particularly those with robust supporting data, have an opportunity to shape their communications in creative ways—with the overarching understanding of how DDMAC is likely to interpret what they say. Such an intimate understanding may well turn regulatory compliance into a competitive advantage. Arnold Friede heads Arnold Friede & Associates, a specialty FDA law boutique