Forest Labs has had a tough time with regulators over the last two years. The company’s sales reps can’t seem to stop breaking the law.
The latest offense, which generated an Untitled Letter from the Office of Prescription Drug Promotion (OPDP), was brought to light through OPDP’s Bad Ad program, which encourages physicians to report on shady sales rep behavior, like off-label promotion or more commonly, risk minimization or broadening the indication of a drug during a sales detail.
Last October, according to the Untitled Letter (dated August 1), Forest reps made statements to physicians that both minimized risks and broadened the indication for Daliresp, a COPD drug. Daliresp launched in August 2011, and earned $31.2 million in Forest’s 2012 fiscal year; the company is forecasting sales of $85 million for 2013. “OPDP is concerned that the violative conduct…occurred despite Forest’s September 15, 2010, Corporate Integrity Agreement (CIA)…that requires Forest to ensure that its policies and procedures address ‘appropriate ways to conduct promotional…functions in compliance with all FDA requirements, and to provide specific training to its employees engaged in promotional functions,” OPDP admonished.
“False and misleading statements from Forest sales representatives are particularly troubling considering OPDP expressed concerns regarding similar violative promotional activities as recently as April 2011,” the letter stated, noting a separate Untitled Letter addressing the promotion of Savella, a fibromyalgia drug, for unapproved uses, as well as a minimization of “serious risks” associated with drug.
Untitled Letters are small potatoes compared with the giant pumpkin of a letter sent from the Office of Inspector General (OIG) to Howard Solomon, chairman, CEO and president of Forest Labs, in April 2011. That letter, the result of a litany of charges including the off-label promotion of two anti-depressants, informed Solomon that he could face exclusion from doing business with government healthcare plans, which would effectively end his career. Solomon has vowed to fight exclusion in court; his attorneys, and their attorney friends, are currently mum on any new developments.
The OIG couldn’t be immediately reached for a status update on Solomon’s exclusion, or whether or not Forest will face additional penalties under its CIA for non-compliance. Check back for updates.