GlaxoSmithKline (GSK) has agreed to pay $105 million to authorities in 44 U.S. states to settle allegations that the company unlawfully misrepresented the uses and qualities of its asthma drug, Advair, and antidepressants, Paxil and Wellbutrin—the pharma’s second settlement in nearly two years over the marketing of its treatments.
The settlement bars GSK from providing incentive payments to its salespeople who encourage off-label promotion of drugs, as well as promoting its products through paid doctors.
“This settlement requires GSK to pay a significant penalty and imposes strong new rules designed to prevent future misrepresentations of GSK products,” California Attorney General Kamala D. Harris said yesterday in a statement.
Harris said California will receive the largest portion of the settlement, nearly $7.1 million. Among other major states, Texas will receive $6.1 million; Illinois, $5.1 million; New York, more than $4.1 million; Pennsylvania, $4.1 million, and New Jersey, $2.45 million, officials in those states announced.
In court papers, California and the other states alleged that between 1999 and 2003, GSK deceptively promoted Paxil as safe and effective for children and adolescents, despite lack of FDA approval and data from three clinical trials linking the drug to increased risk of suicide in such patients.
During that same period, the court complaint alleged, GSK promoted Wellbutrin—then indicated for treating major depressive disorder in adults—for treatment of children as well as for a variety of indications unapproved by FDA, including weight loss, obesity, sexual dysfunction, Attention Deficit Hyperactivity Disorder (ADHD); addictions, anxiety, and bipolar disorder.
GSK was also accused of wrongly promoting Advair between 2000 and the drug’s label change in 2010 as a first line treatment for all asthma patients, including mild asthma patients not on inhaled corticosteroid (ICS) medication and only used short-acting beta agonists (SABAs) intermittently. The pharma giant allegedly also promoted Advair as a first line treatment for mild asthma patients by citing clinical trials dismissed by FDA as offering insufficient evidence for, without telling healthcare professionals of FDA’s stance.
“GSK does not admit any violation of law, and does not admit any wrongdoing,” according to the formal stipulation for entry of final judgment, filed with San Diego County Superior Court.
Under the settlement, GSK agreed to cease:
- Making, or causing to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product;
- Making promotional claims that are not approved or permitted by the FDA, stating that GSK products are better, more effective, safer, or has less serious side effects or contraindications than demonstrated by substantial evidence or substantial clinical experience;
- Presenting favorable information or conclusions from a study that is inadequate in design or scope—or conducting such a study to furnish “significant” support for such information or conclusions, when presenting information about a clinical study regarding GSK products in any promotional materials;
- Providing samples of GSK products to healthcare professionals who are expected to prescribe them for off-label uses, and are not expected to prescribe the samples for an approved use; or
- Disseminating information and materials describing any off-label use of a GSK product, unless they are consistent with FDA regulations and less formal FDA Guidances for Industry.
GSK is also required to continue its Patient First Program at least through March 2019. Patient First reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the judgment requires scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and nonpromotional.
GSK’s settlement with the states comes nearly two years after the pharma giant pleaded guilty to US Department of Justice charges of improper practices, and agreed to pay a $3 billion fine. The federal government alleged that GSK improperly promoted its Paxil and Wellbutrin antidepressants for unapproved uses, and failed to report safety data about the diabetes drug Avandia.
The company agreed to the largest settled fine of any pharma giant under the False Claims or whistleblower act—accounting for GSK topping GEN’s most recent list of Top 10 Biggest Biopharma Marketing Fines, published January 27.
Joining California in the litigation and settlement were the District of Columbia and 43 other states: Alabama, Arkansas, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, and Missouri.
Also, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.