(Adds Glaxo comment, background)
June 4 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
"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
"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.
(Reporting by Bill Berkrot; Editing by Leslie Adler and Diane