PIERRE, S.D.- Attorney General Marty Jackley announced today that he, along with 37 other Attorneys General, reached a record $68.5 million dollar settlement with AstraZeneca Pharmaceuticals LP arising from alleged improper marketing of the antipsychotic drug Seroquel. South Dakota’s share is $909,838.
The complaint, filed today along with the settlement agreement, alleges that AstraZeneca engaged in unfair and deceptive practices when it marketed Seroquel for unapproved or off-label uses, failed to adequately disclose the drug’s potential side effects to health care providers, and withheld negative information contained in scientific studies concerning the safety and efficacy of Seroquel.
“This settlement sends the right message to pharmaceutical companies that they cannot promote a drug to doctors and patients for uses without proper testing and FDA approval,” said Jackley. “This practice puts patients at risk of dangerous side effects that can affect their overall health.”
Following a 3 year investigation, AstraZeneca agreed not to promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses, which are not approved by the U.S. Food and Drug Administration. In addition to the $68.5 million payment, the terms of the settlement include injunctive provisions which address specific concerns identified in the investigation. Along with other prohibitions and requirements, the agreement specifically requires AstraZeneca to:
· Publicly post its payments to physicians on a website;
· Have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing;
· Have policies in place to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use; and
· Cite to Seroquel’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only.
The South Dakota Consumer Protection Division participated in the settlement negotiations.
FOR IMMEDIATE RELEASE: Friday, March 11, 2011
CONTACT: Sara Rabern, (605) 773-3215