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Attorney General J.B. Van Hollen and 44 Other Attorneys General Reach a $105 Million Consumer Settlement with GlaxoSmithKline Concerning the Asthma Drug Advair
 

MADISON — Attorney General J.B. Van Hollen today announced that he and 44 other Attorneys General have reached a $105 million settlement with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline violated consumer protection laws in its promotion of its asthma drug, Advair®, and antidepressant drugs, Paxil® and Wellbutrin®. The Complaint filed today alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs.  Under the settlement, Wisconsin will receive $1,958,888.19.

 

The Proposed Consent Judgment, which was submitted today for the Court’s consideration, requires GlaxoSmithKline (GSK) to reform its marketing and promotional practices.  Specifically, under that Consent Judgment, GSK shall not:

 

  • Make any claim that is false, misleading, or deceptive about any GSK product;
  • Make promotional representations or suggestions, not approved or permitted for use in the labeling or under the Food, Drug and Cosmetic Act 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;
  • For information that may be material to a health care professional’s prescribing decision, 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 or a substantially equivalent program through March 1, 2019.  The Patient First Program reduces financial incentives for sales representatives to engage in improper marketing.  In addition, the Consent Judgment requires scientifically trained personnel to be ultimately responsible for developing and approving clinical responses to health care provider questions regarding a GSK product, and for the data in these responses to be presented in an unbiased and non-promotional manner.

 

Also participating in the settlement are Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wyoming.

 

The State was represented by Assistant Attorney General Phillip D. Ferris. 

 

Copies of the Complaint and the Proposed Consent Judgment submitted to the Court for its consideration are available at the following links:

 

Proposed Consent Judgment

Summons and Complaint