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Prescription Drugs: Consumer Fraud in Sales and Marketing
Pharmaceutical companies have found themselves in the cross hairs of both plaintiffs' lawyers and prosecutors. As a consequence of their sales and marketing practices, these companies have been civilly and criminally fined hundreds of millions of dollars. Meanwhile, the plaintiff's bar is persistently poised to file civil actions almost simultaneously with news of a potential question involving the safety of a prescription medication.
Background
The U.S. Food and Drug Admin- istration ('FDA') must approve all new drugs and accompanying labeling, including all warnings. When submitting a new drug application ('NDA'), the company provides the FDA with data as to the product's safety and efficacy for the treatment of specific conditions at certain strengths. Should the FDA approve that product, its approval is limited only to those conditions and dosages that have been subjected to rigorous testing. The FDA also approves the product labeling, including the language of all warnings and precautions. Approval of a product for one particular indication does not mean that it cannot be used for some other purpose. A physician is permitted to prescribe a product for any use, regardless of the approved labeling. Such a use is termed an 'off-label' use. A pharmaceutical company may not, however, market its products for off-label uses. Marketing of a product for an off-label use results in the product being deemed misbranded and may subject the company to civil and criminal penalties. Both prosecutors and plaintiffs' lawyers are paying close attention to those companies that engage in off-label promotion, particularly where direct-to-consumer advertisements expressly or implicitly promote a product for an off-label use.
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