FDA Ignores Rep. Waxman and Issues Draft Guidance on Good Reprint Practices

In December 2007, we reported on what was a then yet-to-be-released FDA draft guidance on Good Reprint Practices (“GRPs”) and Rep. Henry Waxman’s (D-CA) November 30, 2007 letter to FDA strongly urging the Agency to refrain from disseminating the draft guidance and requesting certain information related to the draft guidance.  On December 21, 2007, FDA responded to Rep. Waxman by providing some of the requested information and refusing to provide other information reflecting ongoing Agency deliberations.  Rep. Waxman penned another letter to FDA in January 2008 criticizing the Agency for not providing much of the requested information.  For now, it appears that FDA is moving forward with the draft guidance.  Last Friday, FDA announced the availability of the draft GRP guidance.  FDA will publish a notice in the Federal Register later this week formally announcing the availability of the GRP draft guidance.  Once finalized, the draft GRP guidance will effectively “replace” FDA’s regulations at 21 C.F.R. Part 99, which expired in September 2006 with the sunsetting of Section 401 of the 1997 FDA Modernization Act.  (We note that many companies did not utilize Part 99 in disseminating reprints, so there wasn’t much to replace.)

As we reported in December, and contrary to the treatment of the subject in the mainstream media, the general principles articulated in the draft guidance are consistent with FDA’s prior approach and are not a radical departure from Agency practice, or, for the most part, current industry practice.  In fact, although Rep. Waxman is concerned that the guidance would “open the door to abusive marketing practices that will jeopardize safety,” the draft guidance provides more restrictive requirements on how the reprint must be disseminated and clarifies the types of documents that FDA considers acceptable for dissemination.  The guidance states that letters to the editors, abstracts, Phase 1 study reports, and reference publications that contain little or no substantive discussion of the relevant investigation or data are not consistent with GRPs.  (As we reported in December, there has been debate among practitioners as to whether these types of documents were appropriate to disseminate.)  In addition, some new requirements include: distributed scientific or medical information should be accompanied by a comprehensive bibliography of publications discussing adequate and well-controlled clinical studies, be distributed separately from information that is promotional in nature, and be in the form of an unabridged reprint, copy of an article, or reference publication that is free of highlighting, markings, and manufacturer summaries. 

Although industry critics are concerned about potential abuse by manufacturers, industry proponents point to FDA’s own statement that the “public health can be served when health care professionals receive truthful and non-misleading scientific and medical information” as support for their position that reprints are beneficial.  In fact, while many companies’ marketing practices will be unaffected by the draft GRP guidance, more aggressive companies may find their marketing practices reigned in.  As Hyman, Phelps & McNamara, P.C.’s Jeffrey Wasserstein (and FDA Law Blog co-author) stated in the Saturday edition of The Wall Street Journal, “There’s tremendous variation in company practices . . . .  [The draft GRP guidelines will] probably restrict the more aggressive companies.”

Considering the early start on the debate surrounding the draft GRP guidance, we anticipate escalating debate in the comings months.  As we noted in December 2007, there is a constitutional dimension to this issue, since the Washington Legal Foundation ("WLF") line of cases made clear that dissemination of reprints was constitutionally protected free speech.  It remains an open question as to whether industry or free speech advocates, such as WLF, will choose to challenge FDA’s guidance on First Amendment grounds, or whether industry will learn to live with this as a reasonable compromise.