Abbott CME use led to Depakote fine
The steady stream of big pharma firms settling with the feds and states for alleged off-label marketing continued with Abbott Labs in May.
Abbott's $1.6-billion payment package—second only to Pfizer's $2.3 billion Bextra penalty of 2009—resolves allegations that the drugmaker used a multifaceted strategy to expand prescriptions for CNS drug Depakote beyond the med's three approved uses (bipolar, epilepsy and migraine prevention) to include controlling agitation and aggression in elderly dementia patients.
Not only was Abbott flagged for inducing its sales force as well as long-term care pharmacies to achieve that end, court papers assert that, from 1998 through 2006, it “improperly and unduly” influenced the content of company sponsored CME programs, in violation of anti-kickback laws.
Abbott pled guilty to a criminal misdemeanor for misbranding Depakote. As part of a five-year probation period, the firm agreed to ensure that CME grant-making decisions are not controlled by sales and marketing, a no-no according to 2005 OIG guidelines.It also signed a five-year corporate integrity agreement requiring, among other things, that Abbott post on its website information about payments to doctors. Breaching the CIA could result in exclusion from federal healthcare programs, including Medicare and Medicaid, and/or monetary penalties.