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Re: Will AMRN market 'off label' benefits? Well they can based on a 2012 U.S. Second Circuit Court ruling This new guidance is way more important than that old court case: http://www.morganlewis.com/pubs/FDA_LF_FDAUpdatesReprintGuidance_06march14.pdf The lengthy Background section (which makes up about a quarter of the guidance) also provides the framework for FDA’s analysis of the issue of establishing a manufacturer’s “intended use,” mentioning the concept numerous times throughout the document. The New Draft Guidance somewhat emphatically reminds industry that [t]o establish a manufacturer’s or distributor’s intended use for [a] product, FDA is not bound by the manufacturer’s or distributor’s subjective claims of intent, but rather can present objective evidence [of that intended use], which may include a variety of direct and circumstantial evidence. This evidence includes reprints and other off-label information or claims disseminated by the manufacturer. As industry knows too well, this concept of “intended use” is not only important from the standpoint of FDA’s misbranding prohibitions, but it also is relevant in the context of other legal challenges. Is there a reason for this rather hefty reminder of the value in FDA’s review process and general requirements with respect to product promotion? Consider that the New Reprint Guidance is issued on the heels of i. ongoing comments on the 2009 Good Reprint Practices guidance, including two citizen petitions 4 asking FDA to clarify its position on the distribution of CPGs, off-label uses, and preapproval communications; ii. a docket that FDA opened to specifically request comments on the principles of scientific exchange; and iii. the decision in United States v. Caronia 5 (where, based on First Amendment principles, a divided Second Circuit panel vacated the conviction of a pharmaceutical sales representative who had promoted off-label uses of a prescription drug), among other legal challenges to FDA over the years. Indeed, the Federal Register notice issued along with the New Reprint Guidance indicates that the guidance is issued as a first step in responding to the citizen petitions and other requests for clarification that FDA has received on the topic. The notice also indicates that, in response to those requests and comments FDA received regarding both the 2009 Good Reprint Practices guidance and its 2011 draft guidance on Responding to Unsolicited Requests for Off-Label Information, 7 FDA is considering a range of options for responding to questions about industry participation in scientific discussions and for addressing industry dissemination of new scientific information related to approved or cleared uses of marketed drugs and devices, including responding to unsolicited requests for off-label information, industry interaction with formulary committees, and exchange of scientific information on off-label uses, generally. While industry is left to consider this and other potential implications of the New Reprint Guidance, in the short term, it faces the task of ensuring that review processes for the dissemination of reprints continue to confirm that the reprints and other materials disseminated under the New Reprint Guidance meet the following criteria: ? They are not false or otherwise misleading. ? They do not recommend or suggest use of a product in such a way that the product is dangerous to health when used in the manner suggested. ? They are not marked, highlighted, summarized, or characterized by the manufacturer, in writing or orally, to emphasize or promote an unapproved use. The New Reprint Guidance also provides tailored checklists for the dissemination of scientific or medical reference texts and CPGs. These checklists include, for instance, requirements that the latest versions of the materials be distributed. With respect to CPGs, specifically, FDA outlines requirements for ensuring that CPGs are “trustworthy,” including, for instance, requirements that the CPG be based on a systematic review of the existing evidence (i.e., rather than just reflective of the preferences of a narrower committee of professionals) and, likewise, that it must be part of an ongoing revision process based on evidence. Although these additional areas of guidance are generally consistent with those discussed above, they are more detailed and consider the differences in these types of publications as compared to shorter items like journal articles, and the guidance will no doubt result in a considerable reshuffling of industry’s current and future plans for the dissemination of off-label information falling into any of these three broad categories. The agreement to allow distribution of CPGs in particular will be considered a welcome expansion of the reprint exemption, as CPGs, which generally represent the endorsement of relevant professional medical societies, carry significant weight with healthcare providers. |
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