Allergan, a pharmaceutical company based in Irvine, Calif., has agreed to pay $600 million for promoting its pharmaceutical drug Botox — commonly used for cosmetic treatment — for uses not approved by the FDA, paying kickbacks to physicians and other violations of the False Claims Act, according to an FBI news release.
Under the Food, Drug and Cosmetic Act, a company must specify each intended use of a product in its application to the FDA. 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. Although Botox has been approved for therapeutic treatment in rare cases, Allergan allegedly falsely promoted its off-label treatment for headaches, pain, spasticity and juvenile cerebral palsy without the FDA's approval. Little clinical evidence showed the drug effectively served as treatment for those conditions, according to the report.
In its efforts to continue aggressive promotion of the drug, Allergan also paid illegal kickbacks to physicians in the form of cash, travel and meals. It also held seminars instructing physicians on how to bill Medicare for off-label procedures, according to the report.
Allergan has agreed to pay $375 million in criminal penalties for misbranding Botox and another $225 million to resolve claims that its unlawful marketing practices caused false claims to be submitted to government healthcare programs such as Medicare and Medicaid. The investigation into Allergan's fraudulent activity began when three lawsuits were filed by five whistleblowers starting in 2007. The whistleblowers will receive payments totaling $37.8 million under the qui tam, or whistleblower, provisions of the False Claims Act, according to the report.
Read the FBI's news release about Allergan's settlement.
Read other coverage about pharmaceutical company settlements:
- New Jersey Pharmaceutical Company Settle Medicaid Fraud Allegations for $2M
- Forest Pharmaceuticals to Pay $313M to Settle Criminal and Civil Charges, Including Paying Kickbacks to Physicians
- Pharmaceutical Company to Pay $27M for Medicaid Fraud
Under the Food, Drug and Cosmetic Act, a company must specify each intended use of a product in its application to the FDA. 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. Although Botox has been approved for therapeutic treatment in rare cases, Allergan allegedly falsely promoted its off-label treatment for headaches, pain, spasticity and juvenile cerebral palsy without the FDA's approval. Little clinical evidence showed the drug effectively served as treatment for those conditions, according to the report.
In its efforts to continue aggressive promotion of the drug, Allergan also paid illegal kickbacks to physicians in the form of cash, travel and meals. It also held seminars instructing physicians on how to bill Medicare for off-label procedures, according to the report.
Allergan has agreed to pay $375 million in criminal penalties for misbranding Botox and another $225 million to resolve claims that its unlawful marketing practices caused false claims to be submitted to government healthcare programs such as Medicare and Medicaid. The investigation into Allergan's fraudulent activity began when three lawsuits were filed by five whistleblowers starting in 2007. The whistleblowers will receive payments totaling $37.8 million under the qui tam, or whistleblower, provisions of the False Claims Act, according to the report.
Read the FBI's news release about Allergan's settlement.
Read other coverage about pharmaceutical company settlements:
- New Jersey Pharmaceutical Company Settle Medicaid Fraud Allegations for $2M
- Forest Pharmaceuticals to Pay $313M to Settle Criminal and Civil Charges, Including Paying Kickbacks to Physicians
- Pharmaceutical Company to Pay $27M for Medicaid Fraud