Pacira Pharmaceuticals, Inc.PCRX announced that it has filed a lawsuit against the FDA seeking a court ruling to defend its rights to promote Exparel for the approved indication. Exparel, Pacira's flagship product, was approved by the FDA in Oct 2011 for administration into the surgical site to produce post-surgical analgesia.
We remind investors that in Sep 2014, the FDA's Office of Prescription Drug Promotion (OPDP) issued a warning letter asking Pacira to immediately stop sharing promotional materials about Exparel's usage in cases other than bunionectomy or hemorrhoidectomy. The OPDP alleged that the company had made misleading statements indicating that Exparel is intended for indications for which it has not been approved. In addition, as per the warning letter, the product label does not provide adequate directions for use in these (other) indications.
Pacira believes that the FDA's actions violate the company's First Amendment right to promote its product using non-misleading information regarding the product. In support of its complaint, Pacira stated that under the Food, Drug and Cosmetic Act, the FDA is not allowed to make such labeling changes, except in specific circumstances in which new safety data about a serious risk associated with the product's usage is revealed after its approval.
Moreover, the Due Process Clause of the Fifth Amendment requires regulatory bodies to establish rules that clearly notify the prohibitions for a particular drug. Pacira alleged that the FDA approved Exparel for a broad indication for controlling post-surgical pain and three years after approval, it accused the company of criminal activity for providing misleading information regarding the drug's usage. According to the company, the FDA created uncertainty and doubt regarding which information it considers permissible for use by the company for the promotion of its product.
Pacira also stated that repeated requests seeking a meeting with the FDA to discuss these issues and clarify the interpretation of Exparel's label were denied by the agency. Moreover, in Aug 2015, the FDA issued a close-out letter to indicate that the matter of the warning letter was considered closed by the agency. Due to the FDA's reluctance to respond to its requests for discussion to resolve these issues, the company has now taken legal action.
Pacira currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Alcobra Ltd. ADHD , Corcept Therapeutics Incorporated CORT and Lannett Company, Inc. LCI . All these stocks carry a Zacks Rank #1 (Strong Buy).
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