Going Off-label, Again

Forest Laboratories is the latest drug maker being charged with defrauding federal and state governments of millions of dollars by illegally marketing two of it’s medications, Celexa and Lexapro, for unapproved uses in kids.

Federal prosecutors alleged in their civil complaint that former top executives at Forest concealed a clinical study that showed that the medications were ineffective in children and might even pose risks, including suicidal tendencies.

Forest aggressively marketed results from an internally financed clinical trial which showed that the medications were safe and effective, without providing the negative study to those scientists, its own sales representatives or its medical advisors.

By failing to disclose the negative clinical trial results, Forest was able to deceive prescribing doctors and the public as to the potential risks involved in using the treatments. Off-label prescribing is a widely used and legal practice, whereby doctors are free to prescribe medications to patients for whom those drugs are not approved by federal regulators. However, it is illegal for drug makers to actively promote such uses.

The government is seeking treble damages against Forest for the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro. Prosecutors have also alleged that Forest used pay-offs, in the form of baseball tickets and gift cards to pricey restaurants, to doctors who played ball–some even received paid vacations. The complaint also charges that Forest ran seeding studies, or trials that were used as marketing tools to promote the drugs. Lexpro is Forest’s biggest product, with sales totaling $2.3 billion in 2008.