Pharmaceutical manufacturer AstraZeneca, based in Wilmington, Del., has agreed to pay $520 million to settle allegations that it had illegally marketed its antipsychotic drug Seroquel, according to an AZ Central news report.
Under the Food, Drug and Cosmetic Act, a company is required to specify each intended use of a product in its application to the Food and Drug Administration. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses, or "off-label" uses, renders the product misbranded. AstraZeneca had been accused of marketing Seroquel as off-label treatment for insomnia and psychiatric conditions, according to the report.
The company had also been accused of paying kickbacks to physicians. The physicians allegedly agreed to be authors of articles written by the company and its agents about the off-label uses of Seroquel. Additionally, physicians were allegedly paid to travel to resort locations to advise AstraZeneca about marketing the off-label use of the drug, according to the report.
Although it has agreed to settle the allegations, AstraZeneca is denying any wrongdoing. State Medicaid programs, including Kansas, will receive a portion of the pharmaceutical company's settlement.
Read the AZ Central news report about AstraZeneca's settlement.
Read other coverage about pharmaceutical company fraud.
- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing
- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud
- Justice Department Files to Intervene in Whistleblower Kickback Case Against Pfizer
Under the Food, Drug and Cosmetic Act, a company is required to specify each intended use of a product in its application to the Food and Drug Administration. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses, or "off-label" uses, renders the product misbranded. AstraZeneca had been accused of marketing Seroquel as off-label treatment for insomnia and psychiatric conditions, according to the report.
The company had also been accused of paying kickbacks to physicians. The physicians allegedly agreed to be authors of articles written by the company and its agents about the off-label uses of Seroquel. Additionally, physicians were allegedly paid to travel to resort locations to advise AstraZeneca about marketing the off-label use of the drug, according to the report.
Although it has agreed to settle the allegations, AstraZeneca is denying any wrongdoing. State Medicaid programs, including Kansas, will receive a portion of the pharmaceutical company's settlement.
Read the AZ Central news report about AstraZeneca's settlement.
Read other coverage about pharmaceutical company fraud.
- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing
- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud
- Justice Department Files to Intervene in Whistleblower Kickback Case Against Pfizer