FDA Removes Pacira Warning Letter in Midst of Free Speech Suit

We have previously written about Pacira Pharmaceuticals, Inc. and their constitutional challenge against the Food and Drug Administration, which alleges that the FDA has placed unconstitutional restrictions on Pacira’s commercial speech. Pacira filed suit to establish its right to provide truthful and non-misleading information to doctors about its anesthetic product, Exparel. The case goes back to September 2014, when the FDA sent a warning letter accusing Pacira of promoting the anesthetic Exparel for unapproved uses and overstating the drugs effectiveness. The FDA concluded their letter by warning Pacira of potential criminal liability if the alleged misconduct continued. After Pacira’s initial receipt of the letter, they sent out corrective statements on Exparel, but eventually filed suit, “asserting that the FDA has silenced its speech in violation of the First Amendment; enforced vague policies in violation of the Fifth Amendment; and abruptly changed Exparel’s approved labeling in violation of the Administrative Procedure Act.” The FDA had initially approved Exparel in 2011 for general use and backtracked three years later in the warning letter when they asserted that Exparel was approved only for two specific surgeries studied in clinical trials. Pacira’s lawsuit against the FDA follows two others: one brought by Amarin Pharma Inc., a First Amendment case involving off-label promotion of omega-3 drug Vascepa; and one brought by the United States against Al...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs