WASHINGTON, Feb 25 (Reuters) - The United States accused Forest Laboratories Inc (FRX.N) of inappropriately marketing the drugs Celexa and Lexapro for children and paying kickbacks like spa visits to pediatricians who prescribed the drugs, the Justice Department said on Wednesday.
Prosecutors said the antidepressant Celexa was no more effective than a placebo when taken by children or teenagers, and, in fact, more patients taking Celexa reported suicidal thoughts or attempted suicide.
The Food and Drug Administration approved Celexa to treat adult depression but refused to approve it for children, and required that Forest put a warning on the labels for Celexa Lexapro. The two are chemically similar.
Frank Murdolo, Forest Laboratory's vice president of investor relations, said that the company was working with the government in an investigation that dates to 2004.
"We've seen the release but that's all we've seen," he said. "We'll look at the complaint, see what's there. We'll see what the next steps are."
Lexapro is Forest's top-selling drug with sales of $585.5 million in the third quarter of fiscal 2009. Celexa lost patent protection and is no longer a major product for the company.
In the complaint, Forest is accused of pushing aside a study showing that Celexa was ineffective for pediatric use and instead urged its sales staff to promote a second, more positive study.
That promotion involved fishing trips, golf and spa outings as well as tickets for physicians to attend sporting events and the Broadway theater as well as meals at fine restaurants, the complaint said.
Some were also given cash for participating on advisory boards.
"Ostensibly, Forest paid physicians to attend these advisory boards to get their feedback on the marketing of Celexa and Lexapro," the complaint said. "In reality, as repeatedly reported in internal company documents, Forest intended that the advisory boards induce the attendees to prescribe more Celexa and Lexapro."
The Justice Department said those actions violated laws that forbid kickbacks.
"The United States alleges that federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest," the department said in a statement.
From Department of Justice:
United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act
Pharmaceutical Company Allegedly Marketed Drugs for Unapproved Pediatric Use and Paid Kickbacks
WASHINGTON – A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company’s marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.
Acting Assistant Attorney General Michael F. Hertz; United States Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation - Boston Field Division; Susan J. Waddell, Special Agent in Charge of Health and Human Services - Office of Inspector General, Office of Investigations; Mark Dragonetti, Resident Agent in Charge of the Food and Drug Administration, Office of Investigations - Office of Inspector General; and Jeffrey Hughes, Special Agent in Charge of the Northeast Field Office of the Veterans Affairs Office of the Inspector General, announced that the civil Complaint against Forest Laboratories Inc., of New York, New York, alleged that the company’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 alleges that a double-blind, placebo-controlled, pediatric trial found Celexa no more effective than the placebo for pediatric use and that, in the study, more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo. The negative efficacy data led the FDA to deny Forest’s request to approve Celexa for pediatric use. It is further alleged that, despite the FDA’s denial of a pediatric indication, 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 same study was among those later considered by the FDA when it mandated that Forest add a "black box" warning to both the Celexa and Lexapro labels.
The Complaint alleges that Forest sought to induce physicians and others to prescribe Celexa and Lexapro by providing them with various forms of illegal remuneration, including cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment and other valuable goods and services, all in violation of the federal anti-kickback statute.
Neither Medicaid nor TRICARE ordinarily cover drugs for off-label uses unless the off-label use is for a medically accepted indication. The United States alleges that federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.
Prior to filing its Complaint, the government had intervened in two separate whistleblower actions against Forest that had been commenced under the qui tam provisions of the False Claims Act. The False Claims Act allows for private persons to file whistleblower suits to provide the government information about wrongdoing. Under the statute, 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 to $11,000 for each false or fraudulent claim filed. If the Government is successful in resolving or litigating its claims, a proper whistleblower can receive a share of between 15 percent and 25 percent of the amount recovered.
This investigation was conducted by the U.S. Attorney’s Office for the District of Massachusetts, the Civil Division of the U.S. Department of Justice, the Federal Bureau of Investigation, the Office of Inspector General of the Department of Health and Human Services, the Office of Criminal Investigations of the Food and Drug Administration and the Office of Inspector General of the Department of Veteran’s Affairs.
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