Ohio to receive part of $105M GlaxoSmithKline drug settlement
Wed, 04 Jun 2014 18:22:20 GMT —
Ohio will receive a portion of a $105 million settlement with a major drugmaker after allegations of unlawful promotions of popular drugs.
Ohio Attorney General Mike DeWine announced the multi-state settlement with GlaxoSmithKline LLC Wednesday after a judgement was submitted Tuesday in Lucas County Common Pleas Court. The settlement resolves allegations that the company unlawfully promoted its asthma drug Advair and antidepressants Paxil and Wellbutrin in 45 states, including Ohio and Michigan.
"Pharmaceutical sales teams were promoting these drugs for off-label uses," Attorney General DeWine said. "This is not only illegal but also dangerous to consumers. The settlement changes the way sales teams are motivated and paid in order to protect consumers from unnecessary risk. Financial gain should never take priority over the health and safety of consumers."
Ohio's share of the settlement is $2,882,287.91.
The judgement also requires GSK to change its marketing and promotional practices, including not doing the following:
· 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; or
· 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.
GSK sales representatives are also required to participate in the Patient First Program, which reduces financial incentives for reps that engage in deceptive marketing.
The District of Columbia and all other 50 states except Alaska, Louisiana, Mississippi, New Hampshire, South Carolina, and West Virginia will receive money in the settlement.