Patients and physicians around the country, including in Georgia, rely on pharmaceutical companies to market their products for the uses for which they are approved by the Food and Drug Administration and nothing else. When a company markets a product for what is called an “off label” use, unintended consequences and side effects can occur. This type of marketing is said to perpetrate a fraud on both physicians prescribing the medication and the patients taking it.
GlaxoSmithKline (GSK) recently reached a settlement with 45 states. The settlement is for $105 million and pertains to certain of the company’s asthma and antidepressant medications. Apparently, the company was marketing Wellbutrin and Paxil for use by children and teens. However, the FDA never approved these drugs for those groups.
Reportedly, Glaxo also marketed Wellbutrin for other conditions for which it did not have FDA approval. Some of those conditions included weight loss, anxiety and attention deficit disorder. The settlement also addresses ways to curb GSK — and other pharmaceutical companies by association — from using deceptive marketing practices. As for the money involved in the settlement, it appears that California will be receiving the lion’s share of the settlement, but several other states are participating as well — including Georgia.
Businesses must be careful not to violate state or federal laws regarding what is considered fraud in advertising. Having an understanding of the laws on this issue is important, but it is equally important to keep abreast of any changes that may occur in those laws. Laws are always evolving, and if not careful, a company may be in violation of the law without even realizing it.
Source: UPI, “GlaxoSmithKline settles $105 million dispute with almost all of America“, Matt Bradwell, June 4, 2014