Update Nov Dec 2013 - (Page 42)

FDLI Activities A Look Back at Advertising and Promotion 2013: A Call for Clarity in First Amendment Jurisprudence-Top A&P Cases of 2012 and 2013 By Jennifer Kane, Manager, Tobacco/Drugs Portfolio; Editor "T he most important FDA judicial trend of our generation" headlined the Top Cases of 2012 and 2013 session on September 16th at the 2013 Advertising and Promotion Conference. Moderator Emalee Murphy, Of Counsel, Arnall Golden Gregory LLP, explained that panelist Ralph Hall, Professor, University of Minnesota, declared the emerging First Amendment jurisprudence "appears to be re-defining the limits of commercial speech." The panel of legal scholars also included Freddy Jimenez, Assistant General Counsel, Johnson & Johnson, Richard A. Samp, Chief Counsel, Washington Legal Foundation, and Kai Peters, Partner, Gordon & Rees LLP. In discussing recent decisions and their implications, the speakers observed the fluid nature of case law, suggesting that companies be proactive as the law evolves. In his overview of First Amendment jurisprudence and FDA, Hall observed that FDA's regulatory scheme developed before commercial speech protection existed, which explains, in part, why this is now an emerging context. Hall stressed the importance of First Amendment cases in defining the "judicial trend of our generation" because these cases address a fundamental pillar (the authorization to market products) of FDA law. Hall emphasized a need for clarity, suggesting that the government and all stakeholders have an obligation to seek justice. With this call for clarity, Hall raised a number of open questions with significant potential for impact on FDA's power, including questions about the standard of review in these cases. He also questioned FDA's ability to prohibit different kinds of speech, including off-label speech, speech regarding investigational products, speech regarding scientific disagreements and mandated warnings of labeling requirements. With the open questions noted, Hall concluded that the government should be actively seeking review of cases like Caronia and Reynolds, 42 Update November/December 2013 citing again the need for FDA to clarify its role and the rules for all stakeholders. Jimenez continued the discussion of First Amendment case law, focusing his remarks on implications and industry responses. He agreed with Hall about the importance of the cases and stated that they raise fundamental issues for doctors and patients in terms of the quality of information available about regulated products. Jimenez echoed Hall's call for clarity and emphasized that rules need to be clear. Even with recent developments in First Amendment case law, he observed that most companies have not made changes to their practices in the short to mid term and that they abide by strict compliance policies under corporate integrity agreements and internal guidance; but he suggested that over time, following further case law developments and public debate, more changes may emerge. Jimenez identified examples of more immediate questions worthy of discussion in companies, including the dissemination of information about endpoints that are not described in labeling but are derived from adequate and well-controlled studies. He referenced the potential shift in the roles of medical science liaisons in proactively providing scientific information in some cases and asking what standards should apply to those interactions-as exercises in scientific exchange or subject to FDA's promotional standards. Jimenez described FDA submissions by the Medical Information Working Group, including comments to FDA dockets and citizen petitions, as well as submissions by PhRMA that pointed out case law developments in a continuing effort to find clarity. Samp discussed a very recent case in Adheris, Inc. v. Sebelius that addressed speech restrictions on refill reminders and therapy-adherence services. He noted that one difficulty for those who feel strongly about First Amendment issues is that many www.fdli.org http://www.fdli.org

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Update Nov Dec 2013