The United States attorney’s office in Boston has filed a civil complaint against drug maker Forest Laboratories for the off-label marketing of antidepressants Celexa and Lexapro to children and teenagers.
According to the complaint, Forest defrauded the government out of millions of dollars by concealing the results of a clinical study which showed that Celexa and Lexapro were not only ineffective in children and teens, but had the potential to cause them to exhibit suicidal thoughts and behaviors.
Instead of disclosing these results to doctors, patients or even its own sales representatives, Forest used the results of another self-financed clinical trial showing that Celexa and Lexapro were effective in young people to market the drugs to children and teens from 2001-2004, despite having FDA approval for adult use only.
By failing to disclose the negative trial results, prosecutors said in the complaint, “Forest told prescribing physicians a half-truth and thereby prevented them and the public from having all potentially available information when making decisions about how to treat a serious medical condition in pediatric patients.”
Doctors are free to prescribe drugs to patients, including children, for whom those drugs are not approved by federal regulators. But it is illegal for companies to actively promote such uses.
The filing follows a long-running federal investigation that began with complaints filed by two former company officials. Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure. -Barry Meier and Benedict Carey, The New York Times
In addition to the off-label marketing, Forest allegedly provided perks such as baseball tickets, expensive dinners, and paid vacations to doctors who prescribed its drugs.
Currently, Lexapro is Forest’s top seller, with 2008 sales numbers of $2.3 billion.