Drug Companies Illegally Market Off Label Use of Their Products

Drug Companies Illegally Market Off Label Use of Their Products

The National Law Journal, in an article by Tresa Baldas, reports the illegal promotion of "off label" use of products by pharmaceutical companies. An "off label" use is the prescription of a drug by a physician for a use which it was not approved or intended. For example, a drug manufactured as an antidepressant might be prescribed by a doctor to treat pain or a drug manufactured for an unrelated use might be prescribed by a physician to treat cancer even though it was not approved by the FDA for that purpose. In the United States physicians are allowed to prescribe medications for purposes other then their original indication because the FDA does not "regulate the practice of medicine" and physicians are entitled to use their own judgment. They may prescribe an FDA approved drug for any use irrespective of the specified purpose given by the manufacturer. In fact, off label use by physicians is widespread.

What is not permitted and is illegal is for the drug company to deliberately market a drug for off label use since the FDA controls drug approval. When it approves a drug for a specific purpose the law limits the manufacturer to promoting the drug only for the purpose approved. But, drug companies have found an opportunity for huge profits by ignoring this restriction. The drug companies sales staff promotes the off label use to broaden its sales base and increase the market for the drug. The practice has been increasing in the last few years. In 2004 Pfizer/Warner-Lambert was fined $430 Million dollars for violating FDA regulations when it engaged in a scheme to promote an epilepsy drug for off label uses based upon the profits earned. The temptation to violate the FDA regulations is huge because of the greatly expanded market that can be created. By promoting it for uses in addition to the limited approval, without having to get FDA approval to do so, the drug companies increase their market and their profits. The problem is that side effects are either not recognized for the off label use or even are deliberately concealed by the drug company.

Congressional investigations have resulted from the widespread use of this practice and state’s attorney generals have also taken action. In addition lawsuits have been filed over the practice including class action suits. In a state of Washington lawsuit, filed by our office, Abbott Laboratories was found negligent for it’s failure to warn about false positives generated by a test for pregnancy it had developed and which was also used as an off label device to diagnose a form of lethal cancer. This is an increasing area of concern.

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