HHS wants input for its TXT4Tots childhood advice program, Gilead releases some Hep. C clinical trial data, and Shire settles with the DOJ over disputed marketing practices.
GlaxoSmithKline will pay $3 billion to settle state and federal charges that it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.
Pharmas shelled out $2.2 billion in False Claims Act fines and settlements with the Justice Department this year as the feds' healthcare fraud haul hit an all-time high.
A federal appeals court has agreed to hear oral arguments about whether the First Amendment protects a sales rep's ability to share information about off-label uses of a drug.
Novartis's recent off-label settlement with the Department of Justice -- to the tune of $422 million -- also included the signing of a Corporate Integrity Agreement (CIA) requiring the Swiss-based manufacturer to review incentive-based compensation for reps, and to examine "the extent to which compensation is based on product performance," according to the CIA.
Forest Laboratories is the latest pharmaceutical company to settle unlawful marketing allegations with a multi-million dollar payout - over $313 million - to the Department of Justice (DOJ), just two weeks after Allergan agreed to pony up $600 million to settle illegal Botox marketing practices.
Before Allergan could begin settlement negotiations with the Department of Justice (DOJ) -- which ended with an agreement to pay $600 million on Wednesday -- DOJ required the Botox manufacturer to first withdraw a First Amendment lawsuit against the FDA filed last October.
As part of an $81 million off-label settlement with the Department of Justice (DOJ), Ortho-McNeil Janssen Pharmaceuticals Inc. (OMJPI) sales reps will be buddied up with internal compliance monitors tasked with observing and reporting the rep's behavior out in the field.
The world's largest pharmaceutical company, Pfizer, and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion, the largest healthcare fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability charges arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.