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Attorneys General Reach $105 Million Settlement With Pharmaceutical Company

Department of Justice | Department of Justice Press Releases | Fraud | Date Posted: Wednesday, June 4, 2014



Attorneys General charge that GlaxoSmithKline illegally promoted medications;

Biden secures more than $1 million for Delaware

DOVER – Delaware Attorney General Beau Biden and 44 of his colleagues announced a $105 million settlement today with GlaxoSmithKline to resolve claims that the pharmaceutical giant unlawfully marketed asthma and anti-depressant medications.

 

The Attorneys General allege that GlaxoSmithKline unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin by misrepresenting the uses and qualities of these drugs. In Delaware, such conduct falls under the Consumer Fraud Act, which is enforced by Biden’s Consumer Protection Unit. Delaware’s share of the settlement will be $1.015 million.

 

On top of the $105 million, the settlement also requires the company to make significant changes in its marketing efforts that will ultimately benefit consumer. Specifically, GlaxoSmithKline shall not:

  • Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any of the company’s product;
  • Make promotional claims, not approved or permitted by the FDA that a company 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 company products to those health care professionals who are not expected to prescribe the sampled company 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 company product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry.

 

The settlement also requires GlaxoSmithKline 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.  In addition, the company will be required to  scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional.

The Attorneys General in Oregon and Illinois led the investigation. In addition to Delaware, other participating states were: Alabama, Arizona , Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, 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, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming.

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Attorneys General Reach $105 Million Settlement With Pharmaceutical Company

Department of Justice | Department of Justice Press Releases | Fraud | Date Posted: Wednesday, June 4, 2014



Attorneys General charge that GlaxoSmithKline illegally promoted medications;

Biden secures more than $1 million for Delaware

DOVER – Delaware Attorney General Beau Biden and 44 of his colleagues announced a $105 million settlement today with GlaxoSmithKline to resolve claims that the pharmaceutical giant unlawfully marketed asthma and anti-depressant medications.

 

The Attorneys General allege that GlaxoSmithKline unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin by misrepresenting the uses and qualities of these drugs. In Delaware, such conduct falls under the Consumer Fraud Act, which is enforced by Biden’s Consumer Protection Unit. Delaware’s share of the settlement will be $1.015 million.

 

On top of the $105 million, the settlement also requires the company to make significant changes in its marketing efforts that will ultimately benefit consumer. Specifically, GlaxoSmithKline shall not:

  • Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any of the company’s product;
  • Make promotional claims, not approved or permitted by the FDA that a company 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 company products to those health care professionals who are not expected to prescribe the sampled company 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 company product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry.

 

The settlement also requires GlaxoSmithKline 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.  In addition, the company will be required to  scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional.

The Attorneys General in Oregon and Illinois led the investigation. In addition to Delaware, other participating states were: Alabama, Arizona , Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, 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, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming.

###

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Related Topics:  , , ,


Graphic that represents delaware news on a mobile phone

Keep up to date by receiving a daily digest email, around noon, of current news release posts from state agencies on news.delaware.gov.

Here you can subscribe to future news updates.