GlaxoSmithKline to Pay $105 Million to Settle Deceptive Ad Charge

GlaxoSmithKline will pay $105 million to settle charges brought by a group of state Attorneys General arising from alleged improper marketing and promotion of the asthma drug Advair and the anti-depressant drugs Paxil and Wellbutrin.

The New York Attorney General’s settlement relating to Paxil builds on a 2006 New York settlement in which GSK agreed to post summaries of clinical studies and establish and maintain a Clinical Trial Register, an official platform and catalogue for registering clinical trials.

GSK was represented by Matthew O’Connor of Covington & Burling in Washington, D.C.

“When pharmaceutical companies advertise drugs to consumers, their claims should be backed by the best available science, not just slick marketing,” said Attorney General Eric Schneiderman. “Medical decisions are among the most personal and important decisions an individual makes, and drug companies should be held accountable for misleading claims made in advertising. New Yorkers should be able to trust that ads for prescription medications are medically accurate.”

The Attorneys General alleged that GSK engaged in deceptive and misleading practices when it marketed Advair, Paxil, and Wellbutrin for off-label uses and concealed risks associated with Paxil.

As a result of the states’ investigation, GSK agreed to change its marketing of Advair, Paxil, and Wellbutrin and to cease promoting off-label uses of the drugs, which are not approved by the U.S. Food and Drug Administration (FDA).

The complaint charged that GSK promoted Advair for treatment of mild and intermittent asthma even though it was approved by the FDA only for treatment of more serious asthma conditions.

GSK promoted Wellbutrin for treatment of weight loss and sexual dysfunction through its “happy, horny, skinny pill,” campaign, even though these were unapproved uses.  GSK concealed and misrepresented clinical studies that demonstrated Paxil’s ineffectiveness in treating children and adolescents with major depressive disorder, as compared to a placebo group, and that demonstrated a connection between Paxil’s use and an increased risk of suicidal thoughts and acts in adolescents.

The settlement prohibits GSK from making, or causing to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product, making promotional claims, not approved or permitted by the FDA, that a GSK product is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience.

The settlement also prohibits the company from presenting 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.

It also prohibits the company from providing 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 use.

And it prohibits the company from disseminating information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry.

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