Drug Company Launched Ad Campaigns Such as “Happy, Horny, Skinny Pill” to Market Drugs for Purposes Unapproved by U.S. Food and Drug Administration
New York, NY - June 4, 2014 - Attorney General Eric T. Schneiderman announced today that he, along with 43 other State Attorneys General and the District of Columbia, reached a $105 million settlement with GlaxoSmithKlein, LLC (GSK) arising from alleged improper marketing and promotion of the asthma drug Advair and the anti-depressant drugs Paxil and Wellbutrin. New York’s share of the settlement is over $4.1 million. The 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.
“When pharmaceutical companies advertise drugs to consumers, their claims should be backed by the best available science, not just slick marketing,” said Attorney General 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.”
In a complaint filed in New York County Supreme Court, Attorney General Schneiderman 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 Attorney General’s complaint charged, among other things, 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;
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;
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; or
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.
The Consent Judgment also requires GSK to continue its Patient First Program through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing by removing individual sales targets and begins the process of ending direct payments to health care professionals for speaking engagements and attendance at medical conferences.
The case was handled by Assistant Attorney General Benjamin J. Lee, Deputy Bureau Chief Laura J. Levine and Bureau Chief Jane M. Azia, all of the Consumer Frauds Bureau. The Consumer Frauds Bureau is part of the Division of Economic Justice, led by Executive Deputy Attorney General for Economic Justice Karla G. Sanchez.
The settlement papers can be read here and here.