Forest Labs said its CEO will challenge a US Department of Health and Human Services attempt to exclude him from participation in federal healthcare programs. HHS notified CEO Howard Solomon of the potential action yesterday by letter, the company said, adding that the missive alleges no wrongdoing and stems from matters the company settled last year. In September Forest paid $313 million and agreed to plead guilty to a felony obstruction of justice charge, and two misdemeanor counts related to the distribution of an unapproved drug—Levothroid—and the misbranding or off-label promotion of two anti-depressants, Lexapro and Celexa. Solomon, who was given 30 days to respond to HHS, would have to step down from his present executive positions if the HHS decides to exercise its exclusion authority.
An FDA advisory panel voted in favor of approving drugs from Pfizer and Novartis for pancreatic neuroendocrine tumors (pNET). The drugs, Afinitor from Novartis and Sutent from Pfizer, are already on the market for treating kidney cancer. Regulatory decisions on the pNET indications are likely to come in late 2011.