Attorney General Marty Jackley Announces $105 Million Consumer Settlement with GlaxoSmithKline
Wednesday, June 4, 2014
PIERRE, S.D.- Attorney General Marty Jackley today announced a settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers. The Attorneys General have reached a $105 million settlement with GlaxoSmithKline, LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its asthma drug, AdvairÂ®, and antidepressant drugs, PaxilÂ® and WellbutrinÂ®. The Complaint and Consent Judgment filed today alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. South Dakota's share of this settlement is $1,182,269.12.
"We are pleased to join this multistate settlement to ensure that consumers are better protected from unacceptable marketing practices. This settlement sends a clear message that these types of allegations will be taken very seriously," said Jackley.
The Consent Judgment also requires GlaxoSmithKline (GSK) to reform its marketing and promotional practices. Specifically, GSK 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; 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.
The Consent Judgment also requires GSK to continue its Patient First Program at least through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing.