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 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.
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 its "Patient
First Program" that reduces the level of financial incentives by
the company to sales representatives in order to reduce
deceptive marketing tactics for five years.
(Reporting by Bill Berkrot; Editing by Leslie Adler)