New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses.1 With minor textual revisions, this new Guidance essentially restates the safe harbors acknowledged in FDA's unofficial 2009 "Good Reprint Practices" Guidance2, and expands them to medical reference texts and clinical practice guidelines. Under the 2014 Guidance, drug and device manufacturers can engage in some forms of distribution of peer-reviewed research about off-label use of their products without fear this will be used as evidence of misbranding. In not backtracking from the 2009 reprint reforms, but rather expanding them to embrace other forms of communication, the 2014 Guidance represents continued evolution of FDA's position on speech concerning off-label use.

This evolution has been tortuous. FDA's initial position, in the early 1990s, was that manufacturers were prohibited from providing doctors with any unsolicited information about use of their products for uses not approved (i.e. "indicated") on product labels. Originally, FDA attempted to enforce its position, while evading judicial review of its constitutionality, through issuing informal warning letters threatening misbranding actions whenever a manufacturer engaged in communications discussing off-label uses. After a judicial decision refused to condone FDA engaging in censorship through ad terrorem threats of prosecution3, in 1996 FDA issued a Guidance which finally made an overt assertion that manufacturers could not distribute reprints or enduring materials like textbooks discussing off-label uses, but were limited to distributing reprints discussing only on-label uses.4 Congress itself found FDA's policy too restrictive, and in 1997 permitted manufacturers to distribute reprints discussing non-approved uses, at least when an application for approval of that use was pending.5 The District Court for the District of Columbia found both the 1996 Guidance and the relevant provisions of the Food and Drug Administration Modernization Act (FDAMA) unconstitutional, and put in place an injunction permitting manufacturers to distribute materials from bona fide peer-reviewed journals and textbooks.6 On appeal, FDA, which had already abandoned defense of the 1996 Guidance, mooted the case by conceding that neither the FDAMA nor a 1997 Guidance on continuing medical education gave it any enforcement authority, but merely identified safe...