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 Alfred Caronia, an employee of Orphan Medical, Inc.
The Caronia ruling was the first of its kind in recent years, stating that a pharmaceutical sales representative’s off-label promotion of a drug was constitutionally protected speech. The majority concluded, “simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”
In the Amarin case, a New York federal judge ruled that Amarin had a constitutional right to make truthful and nonmisleading statements about off-label uses of omega-3 drug Vascepa. U.S. District Judge Paul A. Engelmayer granted Amarin’s motion for a preliminary injunction, arguing that the preliminary injunction will “eliminate the chill on Amarin’s First Amendment rights” and based his opinion largely on the Caronia case, stating that “the court’s considered and firm view is that ... the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.”
Many in the industry have been watching the Pacira lawsuit to see if another federal court will rule in favor of free speech, or go against the grain and rule to suppress the free speech.
In a strange turn of events, the FDA recently quietly unpublished their warning letter that objected to the promotional practices of Pacira. When questioned about the unpublication of the letter, an FDA spokeswoman declined to comment, citing the ongoing litigation between the FDA and Pacira.
The removal of a warning letter is an extremely rare occurrence, as stated by Scott S. Liebman, a Loeb & Loeb LLP partner, who is not involved in the Pacira case. “It is unusual for FDA to take a letter down after posting it. FDA began posting letters in 1997, and I’m not aware of any others that have been unpublished after the fact.”
It is not clear why or when the letter was taken down by the FDA, but some speculate it may be connected with an unpublicized development in the case, such as possible settlement talks.