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GlaxoSmithKline in $105 mln settlement with U.S. states over marketing

Wed, 04th Jun 2014 17:02

June 4 (Reuters) - British drugmaker GlaxoSmithKline Plc has agreed to pay $105 million to settle allegations by44 U.S. states and the District of Columbia that it promoted itsmedicines for unapproved uses, several states attorneys generalannounced on Wednesday.

Glaxo was accused of illegally marketing its big-sellingasthma drug Advair for use by mild asthma sufferers and theantidepressants Paxil and Wellbutrin for use by children andteenagers without FDA approval. Several antidepressants havebeen associated with increased risk of suicide in youngerpatients.

"GlaxoSmithKline put its business interests ahead of what wasbest for vulnerable patients," Illinois Attorney General LisaMadigan said in a statement.

While doctors are allowed to prescribe medicines in any waythey see fit - including so called off-label uses -pharmaceutical companies are allowed to promote their productsonly for indications specifically approved by the U.S. Food andDrug Administration.

"Consumers shouldn't have to wonder whether financialincentives are negatively influencing their medical care,"Michigan Attorney General Bill Schuette said in a statementannouncing his state's $2.6 million portion of the settlement.

Under the settlement, Glaxo is banned from disseminatinginformation describing any off-label use of a product, unlesssuch information and materials are consistent with applicableFDA regulations and FDA guidance.

The settlement also requires Glaxo to continue its "PatientFirst Program" that reduces the level of financial incentives bythe company to sales representatives in order to reducedeceptive marketing tactics for five years. (Reporting by Bill Berkrot; Editing by Leslie Adler)

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