GlaxoSmithKline (GSK) has agreed to plead guilty to three criminal charges and pay an unprecedented $3 billion in criminal and civil fines arising from allegations of illegal promotion of some of its drugs, failure to report safety data and alleged false price reporting. According to prosecutors, GSK illegally promoted Paxil for treating depression in children, even though it was not approved by the FDA for anyone under 18. The company also promoted its drug Wellbutrin for weight loss, the treatment of sexual dysfunction, substance addictions and ADHD when it was only approved for major depressive disorder. In addition, GSK allegedly failed to report safety data about the diabetes drug Avandia to the FDA. In addition to the fines, the company has agreed to be monitored for five years by government officials to attempt to ensure the company’s compliance.
The multi-billion settlement is the largest in U.S. history for healthcare fraud and adds to a string of other settlements with pharmaceutical companies. Critics argue that these large fines are not enough to deter drug companies from unlawful behavior. Since the penalties are considered just part of their operating costs, combined with their huge profits, the critics may be correct. Having dealt with the politically powerful drug industry, I can say without reservation that the FDA must be given more authority to control the drug companies. If the American people knew how weak and ineffective regulation of the drug industry really is, they would demand that Congress make some badly-needed changes. But that would require “running over” the powerful drug industry lobby.
Sources: New York Times and USA Today
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.