Source: Public Citizen
“When drug companies market their products for off-label uses to doctors, hospitals, and others, consumers may be injured or die. After all, an off-label use is a use that the FDA has not found to be safe and effective. In recent years, the FDA and the Justice Department have stepped up their criminal prosecutions of drug companies that market their products for off-label uses.
Yesterday, the Justice Department announced that the Deparment along with its law enforcement partners have reached an historic $3 billion resolution with the pharmaceutical manufacturer GlaxoSmithKline, LLC, to resolve multiple investigations into the company’s sales, marketing, and pricing practices. This action constitutes the largest health care fraud settlement in United States history. [emphasis added]
…GSK will plead guilty to criminal charges and pay $1 billion in criminal fines and forfeitures for illegally marketing and promoting the drugs Paxil and Wellbutrin for uses not approved by the FDA – including the treatment of children for depression, and the treatment of other patients for ailments ranging from obesity, to anxiety, to addiction and ADHD…”
Read the full, original blog post here.
Go here to read the complaint, the plea agreements, and other information concerning the prosecution.
This AP story provides more details.