Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for …
Is Off-Label Enforcement Off Limits?
December 7, 2012 Leave a Comment
On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for …
With Boehringer Ingelheim FCA Settlement, Government Continues To Expand Off-Label Enforcement and Enhance CIAs
October 31, 2012 Leave a Comment
Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”) is the latest pharmaceutical manufacturer to enter into a False Claims Act settlement with the Department of Justice (“DOJ”) predicated on off-label marketing and promotion. Last Friday, October 26, 2012, BIPI agreed to pay $95 million to resolve …
DOJ and GSK Enter Into Record-Setting $3 Billion Settlement, Expansive CIA
July 2, 2012 Leave a Comment
The Department of Justice today announced the largest-ever health care fraud settlement and largest-ever payment by a drug company. Global pharmaceutical giant GlaxoSmithKline LLC (GSK) agreed to pay $3 billion to resolve criminal and civil liability in connection with its drug sale and promotion practices, …
OIG’s Guidance on Excluding Owners and Managers Begins to Take Shape
December 15, 2010 Leave a Comment
The Office of Inspector General (OIG) has exercised its authority to exclude a board member of a sanctioned entity. K-V Pharmaceutical Co. pleaded guilty earlier this year to criminal charges for allegedly misbranding and adulterating drugs. In a settlement with the OIG, Marc Hermelin, a former K-V CEO and …
Noteworthy Indictment for Health Care Lawyers
November 19, 2010 Leave a Comment
Laura Stevens, a former vice president and associate general counsel of GlaxoSmithKline, was charged with obstruction and making false statements during a Food and Drug Administration investigation. This indictment has implications for industry executives and counsel who interact with the FDA or other regulatory …