Off-Label Advertising Ban Sparks Lawsuit
The Food and Drug Administration regulates almost every aspect of prescription drugs in the United States, including manufacturing, labeling, and marketing. To obtain FDA approval for a drug, the manufacturer must demonstrate to the FDA that the drug is safe and effective for its intended use. If the company can demonstrate that the drug is safe for a particular use, the FDA will approve the drug to be advertised and promoted for that intended use. However, once a drug hits the market, it will often be discovered that the drug can be used in ways not contemplated by the manufacturer or submitted to the FDA for approval. Such use is called “off-label” use and accounts for approximately twenty percent of all drug prescriptions in the United States. Off-label use of drugs is not illegal in the U.S., but drug makers are not supposed to advertise off-label uses or attempt to persuade physicians to prescribe their drugs for such uses, as it can be a crime.
Allergen, Inc., the maker of Botox and its sister drug Botox Cosmetic, recently filed a lawsuit against the United States seeking to enjoin the government from preventing drug companies from providing information on off-label uses to the medical community. Allergen contends that it is protected by the First Amendment of the United States Constitution from being prevented from disseminating truthful information to the medical community about effective uses of its drugs, even if they are considered off-label uses. Botox is FDA approved to treat certain types of spasms involving the eye but has other medically accepted, but non-approved, uses such as relieving certain types of spasticity in adults and children. Botox contends that since such “off-label” uses are legal, they should be able to work with the medical community in evaluating the risks and benefits of off-label uses.
The issue in this lawsuit will be whether or not the First Amendment protects Allergen’s right to inform the medical community of the benefits of off-label uses of its drugs. Allergen contends that it takes too long to comply with the procedures for FDA approval to wait for such approval before marketing its drugs for off-label uses. Its stance is that since off-label use is legal and accepted, advertising and promotion of such use should be legal and accepted too. The FDA, however, contends that the public health and welfare depends on drugs gaining FDA approval for specific uses before those uses can be advertised and promoted. If Allergen is successful in obtaining its injunction, drug companies across the United States would potentially be able to encourage the medical community to prescribe their drugs for off-label uses and may be able to advertise their drugs for such off-label uses as well, meaning this lawsuit has the potential to drastically change the pharmaceutical marketing landscape. As experienced Tennessee product liability attorneys, we will be closely following the outcome of this case as it may have a great influence on the safety of consumers.
Sources: http://www.law.com/jsp/article.jsp?id=1202434283040
