Federal Prosecution of Major Drug Manufacturer

The United States Department of Justice has charged the drug maker Forest Laboratories with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.
In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including suicides. The drugs are currently approved by the Food and Drug Administration only for adults.
Doctors can legally prescribe drugs to patients, including children, for whom those drugs are not approved by the FDA, but it is illegal for companies to actively promote such uses
Lexapro is Forest’s biggest product, with total sales of $2.3 billion in 2008.
The complaint alleges that from 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective in children, without disclosing the negative study to the FDA, its own medical advisers or its sales representatives.
The complaint states that 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.
The action follows a 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.
Prosecutors also charged that Forest paid kickbacks, in the form of baseball tickets and gift certificates to expensive restaurants, to doctors who prescribed its drugs, and provided some doctors with paid vacations.

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