GlaxoSmithKline has reached an agreement to pay $105 million to settle claims brought by 45 states over the alleged illegal marketing of the asthma drug Advair, as well as the antidepressant drugs Paxil and Wellbutrin .
The settlement agreement was announced on June 4, by Hawaii’s Department of Commerce and Consumer Affairs. In addition to the monetary portion of the settlement, the states forced Glaxo to make a number of promises to reform its promotional practices and how it compensates sales representatives.
The agreement requires the company to extend its Patient First program, first launched in 2011, until at least 2019. The program changes how the company compensates its sales representatives, by not setting sales targets and rewarding them based on their technical knowledge and the quality of service they provide in support of patient care.
In 2012, the company paid the federal government $3 billion to settle claims that it illegally marketed the drugs Avandia, Paxil and Wellbutrin.
These more recent claims were brought by states and focused mainly on Advair, which the states say the company marketed to people suffering from mild asthma, which is not an approved use of the drug. The company also allegedly attempted to market Paxil and Wellbutrin for use by children, which is also not approved by the FDA.
Drug companies are only allowed to market their products for uses approved by the FDA. Doctors, however, can prescribe drugs for any purpose they see fit.
Advair (salmeterol and fluticasone) is a blockbuster asthma medication manufactured by GlaxoSmithKline PLC, which brings in an estimated $7 billion in sales annually.
In February 2010, the FDA contraindicated Advair and other drugs in the same class, known as long-acting beta agonists (LABAs), for solo use. The agency determined that side effects of Advair and similar asthma medications could increase the risk of severe asthma attacks and death in adults and children. The agency determined that the drugs should only be used if they are being used in conjunction with an asthma controller medication, like an inhaled corticosteroid.
Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.