Nearly eight years ago, an Allergan (AGN) unit paid $150 million to settle criminal charges of illegally marketing three drugs. Now, the U.S. attorney in Boston is being asked to reopen its investigation after newly unsealed documents suggest the company may have deliberately misled federal officials about a key clinical trial for one of the medicines, undermining the basis for the settlements.
Specifically, the documents indicate Forest Laboratories obscured crucial information demonstrating the Celexa antidepressant was not effective in children. Instead, using what its medical director acknowledged was “a masterful stroke of euphemism,” the company portrayed the study results as positive in materials that were submitted to the Food and Drug Administration in hopes of winning approval for pediatric use, according to the court documents.
This is the same study that Forest had improperly touted as evidence its pill was useful in helping children, even though regulators had never approved Celexa for that purpose. Marketing a drug for children that has been approved only for adults is illegal. At the time the settlements were announced in 2010, the Department of Justice pointed to the marketing of the study, known as MD-18, as an important factor in pursuing charges against the drug maker.
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