Attorney General Bob Ferguson announced that legal action by Washington along with 44 other states has resulted in drug manufacturer GlaxoSmithKline, LLC (GSK) paying the states $105 million to resolve claims of deceptive marketing and promotion of non-approved uses of certain drugs. Washington’s share is $2.1 million.
The attorneys general allege that GSK unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin.
The Complaint and Consent Decree filed today in King County Superior Court allege that GlaxoSmithKline violated the Washington State Consumer Protection Act by misrepresenting the uses and qualities of these drugs. This resulted in the drugs being prescribed to patients for “off-label” uses that the Food and Drug Administration had not approved.
“GlaxoSmithKline gambled with consumers’ health to increase profit,” said Ferguson. “I’m pleased our legal action will put a stop to future deceptive business practices.”
Today’s action will result in major changes in GSK’s sales practices to remove incentives for the sales and promotion of off-label uses.
Overview of Consent Decree
In addition to the $105 million payment, the Consent Decree requires GlaxoSmithKline to reform its marketing and promotional practices. GSK shall not:
• Make promotional claims, unless approved or permitted by the FDA that a GSK product is better, more effective, safer, or has less serious
side effects than what has been demonstrated by substantial evidence;
• Provide samples of GSK products to health care professionals who would be
expected to prescribe the sampled product for an off-label use; and
• Disseminate information describing any off-label use of a GSK product, unless such information is consistent with applicable FDA regulations.
The Consent Decree also requires GSK to:
• Continue its Patient First Program through March 2019 which reduces financial incentives for sales representatives to engage in deceptive
marketing; and
• Require scientifically-trained personnel to be responsible for developing and approving unbiased and non-promotional responses to health care provider questions.
Washington participated in this legal action along with Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Wisconsin and Wyoming.
