PROVIDENCE – Attorney General Peter F. Kilmartin announced Wednesday that Rhode Island will receive $1.2 million as its share of a multistate settlement with GlaxoSmithKline LLC to resolve allegations that the company violated state consumer protection laws by misrepresenting its asthma drug Advair and antidepressant drugs Paxil and Wellbutrin.
Under the terms of the settlement, GSK will pay out $105 million to 45 states and continue a Patient First Program to reduce financial incentives that may encourage sales representatives to engage in deceptive marketing.
“This settlement sends a strong message to the pharmaceutical industry that the marketing of drugs for off-label, or not FDA approved, uses will not be tolerated, and the information provided to consumers must be accurate and balanced,” said Kilmartin in a statement.
In addition to the $105 million monetary payout, the settlement also requires GSK to take measures to reform its marketing and promotional practices, including stipulations that 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 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.
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 use.
Disseminate 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.