DoJ Asked to Reopen Forest Celexa Case
A law firm that has been litigating cases against Forest Pharmaceuticals related to its off-label promotion of the antidepressant Celexa (citalopram) for use in children and adolescents says Forest lied to FDA and the U.S. Attorney’s Office and settlements with the company should be reopened. “Documents and testimony obtained in our litigation have been unsealed, over Forest’s objection,” says a letter from Baum Hedlund to a U.S. Attorney civil enforcement official in Massachusetts, “and we have prepared a detailed memorandum outlining Forest’s misconduct and fraud with the hope the U.S. Attorney’s Office will consider reopening its investigation. Obviously, we are not an unbiased source of information, however, we believe the documents and testimony speak for themselves.”
In 2010, Forest agreed to plead guilty to one count of obstruction and two counts of distributing a misbranded drug under the Federal Food, Drug, and Cosmetic Act. The plea agreement imposed criminal fines of $39,500,000 for off-label promotion of Celexa. The company also entered into a civil settlement agreement to resolve various whistleblower False Claims Act lawsuits for both Celexa and Lexapro (escitalopram) for children and adolescents between 1998 and 2005 and agreed to pay $149,158,057.66 to settle the claims. Finally, the company entered into a corporate integrity agreement to address its promotional conduct for a five-year period. “Each agreement was contingent on the others and each agreement required complete honesty from Forest,” the letter says.
The firm particularly calls attention to the promotion and dissemination of a positive Celexa trial in children and adolescents that documents show was not actually positive and says the company misled the government and the public about the trial’s success. It cites an internal document in which a company regulatory affairs manager said part of her job was to create “masterful euphemisms to protect medical and marketing.” The letter says that not only was the disclosure to FDA on the trial dishonest, but a company manager said it was her job to mislead FDA. It also says that the FDA official who approved a new indication for Lexapro said the decision was based on a belief that the clinical trial had yielded positive results and the indication would not have been approved had he known that the trial results were negative.