Abbott got nailed for its off-label promotion of drug Depakote this May. The $1.5B settlement covers civil, criminal, and administrative charges, but the settlement still leaves the door open for prosecutors to come after Abbott management if they fail to comply with onerous post-settlement requirements.
In addition to the monetary settlement, Abbott will have to comply with its new a Corporate Integrity Agreement with the HHS OIG. I cannot imagine what the cost of compliance with these new self-imposed requirements but it must be in the millions or tens of millions of dollars a year.
So, what exactly did Abbott due that was so bad? Child labor? Government bribery? Abbott failed to adequately label its Depakote product between 2004-2006. What exactly did Abbott misstate? Abbott failed to warn that older patients with dementia could become aggressive. Wow, that would seem to be an important warning, I mean a drug that can cause someone to become aggressive is something the patient and the patient’s family and the patient’s community should be warned about. The weird twist for me is that Depakote is used for treating schizophrenia also known as bipolar disease. Depakote is supposed to reduce the symptoms of mania associated with the mania of bipolar disease.
Well, let’s spread the word about the new warnings. And, let’s give a special thanks to the Office of Inspector’s General whose core mission includes protecting the Health and Human Services department from fraud, waste, and abuse.