Good Reprint Practices

In an untitled letter dated April 16, 2009, FDA’s Division of Drug Marketing, Advertising and Communications warned Sanofi Aventis about what it alleges are unsubstantiated claims about the oncology product Taxotere on a reprint carrier.  The letter includes fairly common objections of unsubstantiated superiority claims and overstatements of efficacy. For those of us practiced in the art, these are common themes in FDA’s enforcement record on drug advertising. 

In its letter, FDA focuses on the fact that the reprint itself reports results from a study in which the primary endpoint failed to reach statistical significance and the claims in the reprint carrier emanate from what FDA considers a failed study.  FDA also reiterates its position that superiority claims require TWO  adequate and well controlled studies (actually this FDA interpretation emanates from the plurality of language in the FDCA and implementing regulations-I’ve yet to find the “two” requirement explicitly in either–in fact FDA’s official interpretation of this in its guidance document is more qualified than the language used in FDA’s letter.) 

Nonetheless, the enforcement action is an interesting piece of information to those interested in reprint dissemination under FDA’s Good Reprint Practices Guidance.  In this case, the item itself (from what I can glean from the letter) is clearly a promotional reprint carrier, and even in the aftermath of the Washington Legal Foundation case, reprint carriers have been considered fair game for DDMAC enforcement in even the most industry-friendly interpretations of FDA’s authority to regulate peer-reviewed reprints.  (FDA did not post the reprint carrier itself on its website).  Interesting here though, is that FDA sticks to citing the reprint carrier itself, but not the reprint contained within it (which without doubt contains the same claims or information).  I always find these details interesting, because FDA experts, lawyers, etc. argue amongst ourselves about FDA’s authority to regulate bona fide peer reviewed publications even when they are disseminated by drug companies.  FDA clearly would argue that it has unlimited latitude.  In this current enforcement case I wouldn’t take too much comfort in the focus of the carrier versus the reprint.  Further, I’m seeing a more confident FDA enforcement approach and I wouldn’t be surprised to see FDA unhindered by the reprint/reprint carrier distinction in the future.  Further, with all of the controversies around publications in recent years, I’m not sure of the appetite for industry court cases involving reprints.  Nonetheless, as always…it depends on the facts and one’s knowledge of them.

Yours truly,

John

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