Aug. 1, 2011 — The recent Supreme Court decision in Sorrell v. IMS Health Inc. is earning robust commentary in the legal community because it extends greater First Amendment protection for marketing and expands that protection to data mining and use. In addition, many legal scholars openly are questioning whether the FDA can continue its current regulation of “off-label” communication by drug companies as well as whether the government can continue to use privacy as a justification for marketing limits.
The following are summaries and links to recent articles on the decision written by lawyers from Arnold & Porter, Jenner & Block, and Wiley Rein, as well as an article from the National Legislative Association on Prescription Drug Prices (NLARx) that outlines the organization’s disappointment with the decision.
Does Sorrell v. IMS Health Mark the End of Off-Label Promotion Prosecution? In an article appearing in BNA’s Pharmaceutical Law & Industry Report, Arnold & Porter partners Lisa Blatt, Jeffrey Handwerker, John Nassikas and Kirk Ogrosky discuss the impact of the Sorrell decision on “the debate over the constitutional validity of ‘off-label’ promotion prohibitions.” The authors assert in the piece that Sorrell “provides strong support for challenging FDA’s efforts to regulate what the government calls the off-label promotion of drugs for medical uses that are not approved by the FDA.” Indeed, the authors state, “Sorrell builds on prior Supreme Court precedent in establishing a strong foundation to argue that a pharmaceutical company’s truthful, non-misleading information about its products cannot be subjected to content-based and speaker-based restrictions.” Read more by clicking here.
Does the Supreme Court’s Sorrell Decision Threaten Privacy? An article written by Wiley Rein Partner Bruce McDonald in the firm’s Privacy in Focus publication discusses the role privacy plays in the Sorrell case. Although some privacy advocates assert that the Supreme Court’s decision is a blow to privacy, McDonald states that “another reading is simply that invoking privacy arguments as justification for a statute having another purpose can prove to be an unsuccessful legislative or litigation strategy.” He also comments that the Court’s willingness to give considerable weight to First Amendment protections in a commercial context may trouble privacy advocates, but notes that “a conclusion that the majority decision is anti-privacy would appear to be overreaching,” largely because the majority “clearly doubted” that the Vermont statute in question sought to advance privacy. Read more at http://www.wileyrein.com/publications.cfm?sp=articles&id=7222
Supreme Court Observations: Sorrell v. IMS Health Inc. An article appearing in the Washington Legal Foundation’s Legal Pulse publication, written by Paul M. Smith, chair of Jenner & Block LLP’s Appellate and Supreme Court Practice and co-chair of its Media and First Amendment Practice, analyzes the dissenting opinion in the 6-3 decision. “This dissent reflects a remarkable indifference to the core First Amendment principle that government should not use direct or indirect regulation of speech as a means of influencing people not to make perfectly lawful decisions,” Smith writes. Read more at http://wlflegalpulse.com/2011/06/24/supreme-court-observations-sorrell-v-ims-health-inc/
Will Supreme Court Decision in Sorrell v. IMS Tie States’ Hands in Medical Records Privacy Efforts? The National Legislative Association on Prescription Drug Prices (NLARx) calls the Sorrell decision “a huge disappointment to legislators who have sought to protect the confidentiality of private prescription records.” An article on the NLARx Website, written by NLARx Executive Director Sharon Anglin Treat, states that “the expansive decision by the U.S. Supreme Court, which extends new protections to commercial speech, should be a concern to anyone interested in keeping private information private.” Read more at: http://www.reducedrugprices.org/read.asp?news=6207