LexMonitor

Par Files Complaint Against the Government Claiming that FDA's Off-Label Marketing Regulations Violate the First Amendment

Par filed a Complaint for Declaratory and Injunctive Relief against the United States, the U.S. Food & Drug Administration (FDA), the Commissioner of the FDA, and the Secretary of the Department of Health & Human Services seeking a declaratory judgment that the application of FDA off-label...

Defining Off-Label Marketing Of Prescription Drugs: Conduct Likely To Trigger Government Scrutiny

Here is a copy of the off-label marketing presentation that I prepared for ACI's conference on Fraud and Abuse in the Sale and Marketing of Drugs held last week in New York.  The presentation slides include: A summary chart...

Statistics For Off-Label Marketing Settlements Involving Prescription Drugs

The government settled 21 cases involving allegations of off-label marketing of drugs between 2004 and 2010.   95% of the government’s investigations in these 21 instances were initiated by a qui tam complaint filed pursuant to the False Claims Act.   The...

Pfizer Ordered to Pay $95 Million for Deceptive Marketing of NeurontinThis posting was written by Jody Coultas, Editor of CCH State Unfair Trade Practices Law.Pharmaceutical company Pfizer, Inc. violated the California Unfair Competition Law (UCL) by marketing its prescription drug Neurontin for a...

Texas Court Dismisses Off-Label Device Marketing FCA Case

A federal district court in the Southern District of Texas recently dismissed a qui tam False Claims Act complaint against Medtronic alleging improper off-label marketing.  See United States ex rel. Bennett v. Medtronic, Inc., No. H-08-3408 (S.D. Tex. Sept. 30, 2010).  Following a...