Reporting Off-Label Marketing

Off-label marketing occurs when a company promotes a medication for purposes not approved by the Food and Drug Administration (FDA). The Food, Drug, and Cosmetic Act (FDCA) requires companies to provide information regarding a drug’s intended uses in the application submitted to the FDA for approval. Promoting drugs for purposes not included in the approval application is a violation of FDA guidelines subjecting companies involved in various penalties and fines. In some cases, off-label marketing negatively affects consumers and can lead to class action lawsuits and large payouts. Two of the largest cases related to off-label marketing involved Eli Lilly and Company and Pharmacia & Upjohn Company, Inc.

Eli Lilly and Company

In 2009 Eli and Lily Company (“Eli”) paid $515 million in criminal fines and $800 million dollars in civil settlements for allegations related to off-label marketing for its product, Zyprexa. Zyprexa was approved by the FDA for the treatment of psychotic disorders, bipolar disorder, and schizophrenia. However, Eli promoted the drug for treatment of dementia, Alzheimer’s dementia, depression, anxiety, agitation, aggression, hostility, and sleep disorders. 

The Eastern District of Pennsylvania filed four qui tam lawsuits against Eli claiming that between 1999 and 2005 Eli spent millions of dollars promoting Zyprexa for off-label uses. According to the Eastern District of Pennsylvania, a bulk of the money was spent creating marketing material and training sales personnel to promote Zyprexa in nursing homes and long-term care facilities for treatment of dementia and symptoms related to Alzheimer’s. Additionally, Eli was accused of interfering with the integrity of doctor-patient relationships because medical professionals promoted the drug to receive kickbacks as opposed to recommending the drug for its benefits to patients. 

Pharmacia & Upjohn Company, Inc

In September 2009, Pharmacia & Upjohn Company, Inc. (“Pharmacia & Upjohn”) admitted to off-label marketing of four of its drugs: Bextra, Geodon, Zyvox, and Lyrica. The FDA approved Bextra for anti-inflammatory issues; Geodon was approved as an anti-psychotic drug; Zyvox as an antibiotic; and Lyrica as an anti-epileptic drug. Pharmacia & Upjohn faced nine qui tam lawsuits for promoting these drugs for various indications that were not medically accepted. The major unacceptable indications were promoting the drugs for use at higher dosages than that approved by the FDA. Pharmacia & Upjohn successfully promoted the drugs by offering physicians kickbacks to increase prescribing.

Pharmacia & Upjohn’s unethical practices resulted in the company paying a criminal fine of $1.15 billion. Additionally, the company was forced to forfeit $105 million to resolve criminal restitution for civil liabilities. Overall, Pharmacia paid about $2.3 billion in fines, the highest fines ever imposed upon any company by the United States.

The purpose of the FDA’s application process is to ensure companies abide by specific standards and guidelines when producing and marketing drugs. Companies like Eli Lilly and Pharmacia & Upjohn are hit hardest by large fines and a tarnished reputation, but eventually they recover. However, consumers affected by off-label marketing face higher prices such as non-relief of symptoms, unnecessary health risks, and in some cases death. Fortunately, organizations like the PEW Prescription Project exist to assist physicians with reporting unethical pharmaceutical practices and to assist the FDA with identifying companies promoting drugs for off-label uses.