With the proliferation of prescription drug use in America, pharmaceutical companies are constantly trying to find new uses for medicines already in the marketplace. To gain acceptance for such uses, they engage in a practice called "off-label" marketing. Labeling refers to the approved uses granted by the Food and Drug Administration (FDA) based on research and studies submitted by drug makers. Physicians routinely prescribe medicines for unapproved uses. Off-label uses are legal and often beneficial advances to medicine.
However, it is illegal to advertise a drug for purposes outside of its approved use. This is a growing problem in the pharmaceutical industry, as eight of the 10 largest settlements by the Department of Justice involved pharmaceutical companies. Drug maker Allergan paid $600 million to settle off-label marketing allegations of its anti-wrinkle drug Botox, AstraZeneca paid $520 for improper promotion of Seroquel, and Novartis settled a suit involving epilepsy drugs for $422 million. These settlements come on the heels of billion-dollar settlements by Pfizer and Eli Lilly in 2009.
Off-label marketing has become such an accepted practice, enforcement fines are nearly viewed as a cost of doing business. Pharmaceutical companies continually give free samples and financial incentives to physicians, and impose quotas on sales representatives that could be met only through off-label marketing. Additionally, most penalties pale in comparison to the profits drug makers make on a successful brand, so the reward of getting a blockbuster drug to market is worth the risk of a government inquiry.
Consumer advocates and whistleblowers believe that patient safety should not be compromised in the pursuit of profits. They contend that consumers are at significant risk to off-label marketing because no testing has been conducted on potential side effects, and dosing requirements must be closely studied in order to make medicines safe. They also fear that no regulatory strategy will be effective unless physicians understand the extent of improper marketing practices, as well as the effect it would have on patient safety.
With that said, patients who have been harmed as a result of illegal marketing have the opportunity to hold drug makers accountable through defective product lawsuits. If you have been harmed by a drug given to you though an off-label prescription, chances are that it was a result of off-label marketing. Contact an attorney to learn about your rights and options.