Attorney General Jack Conway today announced Kentucky’s
participation in a multistate settlement that signals a major change in the
way pharmaceutical sales teams are motivated and paid. Kentucky joined
43 other states and the District of Columbia in reaching a $105 million
settlement with GlaxoSmithKline (GSK) to resolve allegations that the
pharmaceutical manufacturer unlawfully promoted its asthma drug, Advair, and
its antidepressant drugs, Paxil and Wellbutrin. The complaint and
consent judgment filed today alleges that GSK violated state consumer
protection laws by misrepresenting the uses and qualities of these
drugs. Kentucky’s share of the settlement is approximately $1.75
office will not tolerate misleading marketing by pharmaceutical companies,”
Attorney General Conway said. “I will continue to investigate and
vigorously pursue cases against drug companies that put profits ahead of
public safety and health.”
consent judgment also requires GSK to reform its marketing and promotional
practices. Specifically, the company shall not:
Make, or cause to be made, any written or oral claim that is false,
misleading, or deceptive about any GSK product.
Make promotional claims, not approved or permitted by the Food and
Drug Administration (FDA), that a GSK product is better, more effective,
safer, or has less serious side effects than has been demonstrated by
substantial evidence or substantial clinical experience.
Present favorable information or conclusions from a study that is
inadequate in design, scope, or conduct to furnish significant support for
such information or conclusions, when presenting information about a clinical
study regarding GSK products in any promotional materials.
Provide samples of GSK products to those health care professionals who
are not expected to prescribe the sampled GSK products for an approved use,
but who would be expected to prescribe the sampled product for an off-label
Disseminate information describing any off-label use of a GSK product,
unless such information and materials are consistent with applicable FDA
The consent judgment also requires GlaxoSmithKline to
continue its “Patient First” program at least through March of 2019.
“Patient First” reduces financial incentives for sales representatives who
engage in deceptive marketing. In addition, the judgment requires
scientifically trained personnel to be ultimately responsible for developing
and approving responses to health care provider questions and for these
responses to be unbiased and non-promotional.
In addition to Kentucky and the District of Columbia, the
states participating in the settlement were Alabama, Arizona, Arkansas,
California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan,
Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New
York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania,
Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia,
Washington, Wisconsin, and Wyoming.
You can follow Attorney General Conway on Twitter @kyoag, visit the Attorney
General’s Facebook page
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