Distribution of Off-Label Reprints by Pharma: Are FDA’s New Revised “Rules” Too Limiting?
Distribution of Off-Label Reprints by Pharma: Are FDA’s New Revised “Rules” Too Limiting?
Survey began 18 May 2014
In February 2014, FDA released a new draft guidance document entitled Distributing Scientific and Medical Publications on Unapproved New Uses -Recommended Practices.
FDA’s revised guidance is aimed at addressing some of industry’s and the public’s concerns regarding the previous guidelines by making clear that the pharmaceutical and medical device industries can distribute medical and scientific reprints — including reprints of studies for new and unapproved uses of drugs — to medical professionals, but only under certain conditions.
It appears that the drug industry is still not satisfied with the proposed guidelines. In particular, the Washington Legal Foundation (WLF), in its comments submitted to the FDA. cites three items with which it has problems.
(1) FDA proposes that scientific and medical journal articles should be from a peer-reviewed journal, be distributed in unabridged form (i.e. reprint), contain information from an “adequate and well-controlled clinical investigation” and be “scientifically sound.” WLF wants the FDA to eliminate any reference to “adequate and well-controlled clinical investigation,” a reference that, according to the WLF, “likely will be interpreted as imposing severe limitations on the types of journal articles that may be disseminated.”
(2) FDA proposes that FDA-approved labeling should be disseminated along with the literature, as well as a comprehensive bibliography of information from other publications (including contradictory literature) and separate from any promotional literature. WLF wants the FDA to narrow the overly burdensome “disclaimer” requirements, such as that the article be accompanied by a comprehensive bibliography and articles/texts expressing contrary or different conclusions.
(3) The WLF also wants the FDA to “scale back on the limitations” imposed on disseminating medical texts, particularly the distribution of individual chapters from a medical text. “In the absence of such revisions,” says WLF, “it will be virtually impossible for manufacturers to distribute reprints in a manner that complies with the Draft Guidance.”
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