Like targets at a Department of Justice shooting gallery, drugmakers are going down on marketing violations. The latest is Forest Laboratories, which agreed to a $313 million settlement. The misbehavior: selling an unapproved drug, marketing another drug off-label, and lying to FDA inspectors during a visit.
The company's Forest Pharmaceuticals unit pleaded guilty to criminal charges of marketing its unapproved thyroid drug Levothroid--and ignoring the agency's warnings to stop. The plea also covers charges of "misbranding" its antidepressant drug Celexa, which basically means that it promoted the drug for off-label use. In this case, Forest pushed Celexa for use in children even though it was only approved for use in adults, an FDA statement says.
Prosecutors also say that Forest sales reps paid doctors to persuade them to prescribe Celexa and its successor drug Lexapro, giving them cash "disguised as grants or consulting fees," plus expensive meals and entertainment, such as Broadway tickets, a deep-sea fishing trip, and pro baseball tickets. Forest "expressly denies" those claims, despite its agreement to pay some $148 million to settle those and other civil complaints.
Forest's deal--and the charges associated with it--are mostly familiar by now, what with the feds racking up settlement after settlement. This deal hits the news just two weeks after the $600 million Allergan settlement for mismarketing its wrinkle drug Botox. And of course there were those big settlements with Pfizer (Bextra and other drugs, $2.3 billion) and Eli Lilly (Zyprexa, $1.4 billion).
- see the FDA statement
- here's the DoJ release
- get the story from the New York Times
- check out the Bloomberg coverage
- read the Wall Street Journal piece