(Adds Glaxo comment, background)
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 by the states of illegally marketing itsbig-selling asthma drug Advair for use by mild asthma sufferersand the antidepressants Paxil and Wellbutrin for use by childrenand teenagers 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.
The settlement resolves legal claims against the company"regarding historic matters that relate to violations of statetrade practices laws and are similar to the matters settled withthe federal government in 2012," Glaxo said in a statement.
The company in 2012 pleaded guilty to criminal charges andagreed to pay a pharmaceutical industry record $3 billion incivil and criminal fines for promoting its antidepressants forunapproved uses and for failing to report safety data on itsAvandia diabetes drug.
Under the latest settlement with states, Glaxo did not admitto any wrongdoing or liability under the states' laws, it said.
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 for fiveyears, its "Patient First Program" that reduces the level offinancial incentives by the company to sales representatives toreduce deceptive marketing tactics.
The company said it had put in place a series of reforms,including stopping payments to doctors for speaking about itsproducts, halting payments to doctors to attend medicalconferences and cutting the tie linking the pay of salesrepresentatives who call on prescribers in the U.S. to thenumber of prescriptions issued. (Reporting by Bill Berkrot; Editing by Leslie Adler and DianeCraft)
Glaxosmithkline (GSK)
