{"id":4541,"date":"2016-12-06T01:07:00","date_gmt":"2016-12-06T01:07:00","guid":{"rendered":"https:\/\/www.healthlawpolicymatters.com\/?p=4541"},"modified":"2021-11-03T01:08:44","modified_gmt":"2021-11-03T01:08:44","slug":"off-label-marketing-first-amendment-challenge-ruling","status":"publish","type":"post","link":"https:\/\/www.healthlawpolicymatters.com\/2016\/12\/06\/off-label-marketing-first-amendment-challenge-ruling\/","title":{"rendered":"Off Label Marketing \u2013 First Amendment Challenge Ruling"},"content":{"rendered":"\n

The U.S. Court of Appeals for the 2nd<\/sup>\u00a0Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing,\u00a0http:\/\/www.ca2.uscourts.gov\/decisions<\/a>.\u00a0\u00a0 Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions.\u00a0 But it is important to recognize the limits of the court\u2019s December 3rd<\/sup>\u00a0ruling.<\/p>\n\n\n\n

The Food Drug and Cosmetic Act\u2019s (FDCA) misbranding provisions, 21 U.S.C. Sections\u00a0331<\/a>\u00a0and\u00a0333<\/a>, are traditionally used by the government to prosecute off-label marketing cases:\u00a0 intentional off-label marketing cases prosecuted as felony misbranding violations and strict liability cases as misdemeanor violations.\u00a0\u00a0 The government asserts that when a drug is marketed for uses not approved by the FDA, the drug is misbranded because its existing label does not adequately address the off-label uses.<\/p>\n\n\n\n

In a split decision, the appellate court found that in convicting Caronia for conspiracy to introduce a misbranded drug into interstate commerce under the FDCA, the government prosecuted Caronia for his speech alone, which was not permissible under the First Amendment.\u00a0 The court was persuaded by the fact the government never contended that Caronia said anything untrue or misleading about the drug products at issue, just that he promoted the products for uses not approved by the FDA.\u00a0\u00a0 The court was also guided by the Supreme Court\u2019s 2011 decision in\u00a0Sorrell v. IMS Health<\/a>,\u00a0<\/em>holding that speech in aid of pharmaceutical marketing is a form of expression protected by the First Amendment.\u00a0 With that precedent, the appellate court ruled that truthful off-label promotion was not tantamount to misbranding under the FDCA and reversed Caronia\u2019s conviction.<\/p>\n\n\n\n

But the appellate court did not <\/strong>strike down any portion of the FDCA.  And the court did not limit the government\u2019s authority to prosecute individuals or entities under the FDCA for off-label marketing which is allegedly false or misleading, such as alleged suppression of clinical study results or misrepresentation of the extent of FDA approval.  What the court did say is that truthful off-label promotion of an FDA approved drug, without anything more, is protected speech and cannot be prosecuted as misbranding under the FDCA.<\/p>\n\n\n\n

It is doubtful this ruling will mark the end of the Caronia <\/em>case.  This was a split decision; the dissent persuaded that the defendant\u2019s off-label marketing was merely evidence of the misbranding, so that Caronia\u2019s conviction was not based on his speech alone.   Motions, potential rehearings, and an eventual appeal to the Supreme Court are likely next steps.  But with the plethora of pending off-label marketing cases, both criminal cases and parallel civil False Claims Act cases, we can be sure that government attorneys, defense attorneys, and whistleblower attorneys will all be paying close attention to what happens next.<\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Court of Appeals for the 2nd\u00a0Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing,\u00a0http:\/\/www.ca2.uscourts.gov\/decisions.\u00a0\u00a0 Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions.\u00a0 But it is important to recognize the limits of the … Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_generate-full-width-content":"","footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4541"}],"collection":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/comments?post=4541"}],"version-history":[{"count":2,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4541\/revisions"}],"predecessor-version":[{"id":4543,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/posts\/4541\/revisions\/4543"}],"wp:attachment":[{"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/media?parent=4541"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/categories?post=4541"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.healthlawpolicymatters.com\/wp-json\/wp\/v2\/tags?post=4541"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}