The US government Wednesday filed a complaint against pharmaceutical Forest Laboratories Inc. for marketing an anti-depressant that was not approved for children and paying kickbacks to doctors who prescribed it.
The Justice Department alleges that Forest's "illegal promotional practices surrounding its antidepressant drugs Celexa and Lexapro caused thousands of false and fraudulent claims to be submitted to federal health care programs."
The complaint refers to a clinical trial that found Celexa "no more effective than the placebo" for children's use, and that "more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo."
The Food and Drug Administration (FDA), which regulates and supervises the safety of foods, drugs and medical products and devices, had turned down Forest's request to approve Celexa for pediatric use.
The FDA later also mandated that Forest add a clear warning on Celexa and Lexapro labels, the Justice Department said.
Despite the FDA's actions, it added, Forest "actively promoted pediatric use of the drugs and misled physicians and the public by failing to disclose the results of the negative study."
The company also tried to "induce physicians and others to prescribe Celexa and Lexapro by providing them with various forms of illegal remuneration, including cash payments ... expensive meals and lavish entertainment ... all in violation of the federal anti-kickback statute," the complaint added.
The US government said it based its complaint on two whistleblower actions against New York City-based Forest, under the False Claims Act.
Under the statute, the Justice Department explained, "if it is established that a person has submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and 5,500 dollars to 11,000 dollars for each false or fraudulent claim filed."
In a successful litigation, whistleblowers stand to receive a share of between 15 percent and 25 percent of the amount recovered, it added.