Off-label marketing in the pharmaceutical drug industry has become more and more common. Drugs are typically approved by the Food and Drug Administration (FDA) for specific purposes or uses, which doctors and consumers can obtain from the product’s label information. However, drug companies often market their drugs for purposes other than those that the FDA has approved, otherwise known as off-label marketing. Off-label marketing offers the drug companies the opportunity to sell their drugs to a wider audience of consumers who would not have used these drugs otherwise. The additional profits that drug companies can make from off-label marketing can be substantial.
One example of off-label marketing can be seen in several lawsuits filed against the makers of Lexapro and Celexa, which are in a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Specifically, Forest Laboratories is the Defendant in several SSRI related civil lawsuits claiming that Lexapro and Celexa caused or contributed to persons committing or attempting suicide. Additionally, it has been reported that the U.S. Attorney’s Office is investigating whether to bring criminal charges against Forest Labs for violations of the Federal Anti-Kickback laws with off-label marketing activities in the promotion of Lexapro and other products. To date, subpoenas have been issued to Forest Labs requesting documents relating to the company’s marketing and promotional activities since 1997.
Forest Labs, along with other SSRI drug makers, allegedly has been marketing Lexapro for the off-label treatment of many different kinds of illnesses not approved by the FDA, by promoting the notion that every uncomfortable feeling is caused by a “chemical imbalance.” In other words, the drug companies making these drugs have transformed everyday sadness, stress, and worry into mental disorders that only drugs can resolve. The major off-label marketing campaign of mental illness drugs have led many consumers to believe that drugs are needed for normal life-related distress. However, because many doctors are not trained on the side effects of SSRIs, consumers can have a wide range of reactions or behaviors that appear to be symptoms of another “disorder,” and are then prescribed more drugs to counter the unrecognized adverse reactions to the first.
This example of off-label marketing and consumer use is all too common for other classes of drugs in the pharmaceutical industry as well. Therefore, consumers must be proactive when being prescribed new medications by their doctors. Consumers should discuss carefully with their doctors any new medication that is being prescribed.
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