Health
SAN FRANCISCO – Attorney General Kamala D. Harris on Wednesday announced a $105 million multistate settlement with GlaxoSmithKline, LLC (GSK) to resolve allegations that the company unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin. California’s portion of the settlement is the largest of any state, at $7,087,897.
For the first time in a settlement with a large pharmaceutical manufacturer, GSK is prohibited from providing incentive payments to its salespeople, which serve to encourage off-label promotion of drugs, and from using paid doctors to promote its products.
“Patient care is undermined when pharmaceutical companies promote uses for drugs that have not been approved by the FDA or pay medical professionals to promote certain drugs,” Attorney General Harris said. “This settlement requires GSK to pay a significant penalty and imposes strong new rules designed to prevent future misrepresentations of GSK products.”
The complaint and stipulated judgment, submitted Wednesday to the San Diego County Superior Court, alleges that GSK violated state consumer protection laws by misrepresenting the uses and qualities of certain drugs.
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 stipulated 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.
In addition, the judgment requires 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 nonpromotional.
Forty-three additional states and the District of Columbia participating in the settlement include: Alabama, Arkansas, 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, Wisconsin and Wyoming.
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SACRAMENTO – California Department of Public Health (CDPH) Director and State Health Officer Dr. Ron Chapman has warned people not to eat Navitas Naturals Organic Sprouted Chia Powder, Navitas Naturals Omega Blend Sprouted Smoothie Mix, and Williams-Sonoma Omega 3 Smoothie Mixer because they may be contaminated with salmonella.
As of May 27, 2014, 12 patients infected with the same rare strain of Salmonella have been reported in the United States, including two patients from Southern California.
One case-patient in another state has been hospitalized and no deaths have been reported. Interviews conducted with case patients suggest that chia powder may be the source of the illness cluster.
Navitas Naturals of Novato has initiated a voluntary recall of the following products due to the potential for Salmonella contamination. The products were sold nationally through retail grocery stores, natural food markets, and via on-line sales.
- Navitas Naturals Organic Sprouted Chia Powder (8 oz.); best buy date, 04/30/2015 through 09/05/2015;
- Navitas Naturals Omega Blend Sprouted Smoothie Mix (8 oz.); best buy date, 07/29/2015 through 09/19/2015;
- Williams-Sonoma Omega 3 Smoothie Mixer (8 oz.), best buy date, 09/12/2015 through 10/02/2015.
While Navitas Naturals has notified retailers of the recall and asked that the product be removed from store shelves, CDPH is concerned that consumers may still have some of these products in their homes. Consumers in possession of these recalled products should discard them or return them to the place of purchase for a refund.
Symptoms of Salmonella infection include fever, abdominal cramps, and diarrhea which may be bloody.
Most infected people recover within a week. Some may develop complications that require hospitalization. Infants, the elderly, and people with weakened immune systems are at highest risk for more severe illness.
CDPH recommends consumers experiencing any ill effects after consuming these products consult their health care provider.
Consumers that observe the product being offered for sale are encouraged to report the activity to the CDPH toll free complaint line at 800-495-3232.
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