OFF LABEL PROMOTION OF PHARMACEUTICAL DRUGS UNDER THE CARONIA AND AMARIN CASES

Abstract

The Food and Drug Administration approval is necessary before a manufacturer can distribute a drug or medical device in the market. Congress amended the Federal Food Drug and Cosmetic Act (FDCA) by enacting the Drug Amendments of 1962. The aforementioned require manufacturers to demonstrate that their drugs are both safe and effective for their intended uses before they are approved for distribution.  Under the FDCA, a manufacturer may not introduce or deliver for introduction into interstate commerce any new drug that the FDA has not approved.

The FDCA also prohibits the introduction or delivery for introduction into interstate commerce of a drug that is misbranded, even if FDA has approved the drug The FDCA states that a drug or device is misbranded if its labeling is false or misleading in any particular. Labeling includes the label and any other written, printed, or graphic material that accompanies a device and any of its wrappers or containers. The labeling must include adequate directions for use of drugs and medical devices and any warnings necessary to protect the health of the user.

FDA regulations incorporate the intended use. The term “intended use” refers to the objective intent of the persons legally responsible for the labeling of drugs. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. The materials that may serve as proof of a manufacturer’s intended use include the promotional statements by the company or its representatives. “Off-label promotional statements could constitute evidence of an intended use of a drug that the FDA has not approved.” 

A number of recent cases between pharmaceutical companies or representatives and the federal government have involved a novel legal argument that the truthful and non-misleading speech relating to an off label use is protected under the First Amendment of the United States Constitution. "Where off-label prescribing is ineffective or ill-advised, the FDA has a legitimate, compelling interest in protecting the public health by ensuring that companies do not transmit false or misleading information, or otherwise encourage off-label prescribing when there is no underlying medical basis. But where the challenged off-label information is truthful, what is the public interest in forbidding it?"

It is relevant to consider how effective FCA sanctions may be for a company with an extensive pipeline of products to treat several conditions.  For example, how significant to Pfizer is a FCA settlement of $2.3 billion compared with 2014 reported revenues of $49.6 billion?  It represents almost five percent of the revenue for a given year.  That money may be invested in research and development of new products to treat patient conditions.