Friday, February 27, 2009

Pharmaceutical company in trouble for attempts to get doctors to prescribe drug to children

The New York Times reports that the Justice Department has filed a complaint against a pharmaceutical company for violations of FDA regulations. The charges were filed last Wednesday against the drug maker Forest Laboratories for defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers. The drugs are currently approved by the Food and Drug Administration only for adults. The complaint alleges 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 causing some to become suicidal. It also alleges that from 2001 to 2004, Forest heavily promoted results from a clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives. 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. 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. 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. Currently, drug makers are required to disclose the results of all their clinical trials. But the issues surrounding Forest’s marketing of Celexa and Lexapro date to before those rules were in place. For the full story, click here.

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