February 25, 2009
Drug firm slapped with federal complaint
U.S. authorities accused a New York pharmaceutical company Wednesday of making false claims about two antidepressants it markets for unapproved pediatric use.
The civil complaint unsealed in U.S. District Court in Massachusetts, not only alleges Forest Laboratories Inc. marketed Celexa and Lexapro improperly but that it paid kickbacks to doctors to prescribe them.
The federal complaint alleges that a double-blind, placebo-controlled, pediatric trial found Celexa no more effective than the placebo for pediatric use. The study also found more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo. Those results led the FDA to deny Forest's request to approve Celexa for pediatric use but the government alleges the company promoted the drugs for children anyway.
The complaint alleges Forest gave doctors 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.