Penalized for "On-Label" Marketing? In Wake of Amarin, Pacira Files First Amendment Complaint Against FDA

Last week, Pacira Pharmaceuticals, Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to establish its right to provide truthful and non-misleading information to doctors about its anesthetic product, Exparel. This case follows last month’s decision in Amarin v. FDA, in which the Southern District of New York held that, under the First Amendment, FDA could not restrict Amarin Pharma’s ability to promote truthful non-misleading off-label information about Vascepa. Pacira's case brings a number of interesting facts to the table that have the potential to further shape how FDA regulates promotion of pharmaceutical and device products.  Background on Exparel Pacira demonstrated Exparel’s safety and effectiveness in providing postsurgical pain control through two clinical trials. “Pacira conducted these pivotal studies in two very different surgical procedures: bunionectomies, which involve an orthopedic and hard tissue site, and hemorrhoidectomies, a highly vascular soft tissue site,” the company writes in its complaint. “These two successful trials in markedly different surgical sites provide a valid basis—consistent with FDA’s own practice—from which to determine that EXPAREL can be used safely and effectively in any surgical site.” 2014 Warning Letter However, Pacira’s lawsuit alleges that in 2014, “nearly three years after FDA approved EXPAREL for use in surgical sites generally and after receiving, without objection, thr...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs