WASHINGTON D.C. (BNO NEWS) – Allergan, a pharmaceutical company, agreed on Wednesday to a $600 million settlement for aggressively promoting its flagship drug Botox and other violations of the False Claims Act.

“This case sends a clear message that the FBI will not allow manufacturers to promote their prescriptions or products for uses beyond their intended purpose,” said Brian Lamkin, FBI Atlanta special agent in charge.

Allergan, an international company based in California, also promoted Botox for uses not approved by the Food and Drug Administration (FDA). Botox is known for its cosmetic use but the FDA also approved its therapeutic use.

For nearly a decade, Allergan promoted the drug to treat headaches, pain, spasticity, and juvenile cerebral palsy. This was made to maximize sales in the lucrative off-label market and without the FDA’s approval.

As part of the promotion, the pharmaceutical company gave kickbacks to doctors in cash, travels and meals. Allergan also held seminars where doctors were instructed on how to bill Medicare for off-label procedures.

The company also made false and fraudulent statements regarding Botox’s efficacy for those off-label treatments. Allergan even lied when there was little or no clinical evidence that the uses were effective. The company reportedly earned millions of dollars thanks to this practice.

“When a pharmaceutical manufacturer violates the integrity of the drug approval process established by Congress and the FDA by paying kickbacks to encourage the off-label use of an unapproved drug, that not only undermines the judgments of health care professionals, it also threatens to put patients’ health and safety at risk,” Tony West, Assistant Attorney General said.

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