British drugmaker GlaxoSmithKline Plc has agreed to pay $105 million to settle allegations by 44 U.S. states and the District of Columbia that it promoted its medicines for unapproved uses, several states attorneys general announced on Wednesday.
Glaxo was accused by the states of illegally marketing its big-selling asthma drug Advair for use by mild asthma sufferers and the antidepressants Paxil and Wellbutrin for use by children and teenagers without FDA approval. Several antidepressants have been associated with increased risk of suicide in younger patients.
"GlaxoSmithKline put its business interests ahead of what was best for vulnerable patients," Illinois Attorney General Lisa Madigan said in a statement.
The settlement resolves legal claims against the company "regarding historic matters that relate to violations of state trade practices laws and are similar to the matters settled with the federal government in 2012," Glaxo said in a statement.
The company in 2012 pleaded guilty to criminal charges and agreed to pay a pharmaceutical industry record $3 billion in civil and criminal fines for promoting its antidepressants for unapproved uses and for failing to report safety data on its Avandia diabetes drug.
Under the latest settlement with states, Glaxo did not admit to any wrongdoing or liability under the states' laws, it said.
While doctors are allowed to prescribe medicines in any way they see fit - including so called off-label uses - pharmaceutical companies are allowed to promote their products only for indications specifically approved by the U.S. Food and Drug Administration.
"Consumers shouldn't have to wonder whether financial incentives are negatively influencing their medical care," Michigan Attorney General Bill Schuette said in a statement announcing his state's $2.6 million portion of the settlement.
Under the settlement, Glaxo is banned from disseminating information describing any off-label use of a product, unless such information and materials are consistent with applicable FDA regulations and FDA guidance.
The settlement also requires Glaxo to continue for five years, its "Patient First Program" that reduces the level of financial incentives by the company to sales representatives to reduce deceptive marketing tactics.
The company said it had put in place a series of reforms, including stopping payments to doctors for speaking about its products, halting payments to doctors to attend medical conferences and cutting the tie linking the pay of sales representatives who call on prescribers in the U.S. to the number of prescriptions issued.