The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.
Companies receiving warning letters of late include: Eli Lilly, J&J, Novartis, and Shire. Boehringer-Ingelheim (Mirapex, for restless legs syndrome) and Forest Labs (Bystolic, an antihypertensive) have also been warned by DDMAC, as have nutraceutical companies such as New Sun, Inc. and A1 Discount Vitamins.
Regarding the ADHD drugs, the key issue for FDA seems to be overstatements about efficacy. And no materials or marketing methods seem safe from DDMAC's watchful eye. J&J, for instance, was cited for a statement it made on a professional convention poster: "Concerta helps children improve academic performance throughout the day." Clearly, the Concerta brand team failed to exercise good judgement in making such a statement, but the fact that the claim was outside the realm of direct-to-consumer marketing is noteworthy (though J&J was also reprimanded for claims it made on Concerta's website as well).
The FDA Law Blog also notes how FDA is seriously questioning manufacturers' "substantive evidence" behind their claims. Does your research really prove what you're saying it does, the Agency seems to be asking. FDA Law Blogger Carrie Martin wonders whether this is a matter of DDMAC cracking down on loose claims in general, or whether its a case of reining in a situation where one ADHD manufacturer pushed the marketing envelope and its competitors followed suit.
Regardless, no doubt the warning letters have implications far beyond the ADHD marketing world. It's no secret that Lilly, already fined for Zyprexa and now under fire for Strattera marketing, has instituted much tougher internal oversight of all of its marketing practices. One would imagine that J&J, Novartis, Shire and others are doing the same.
--PWT
