Japanese Drugmaker Pays $4M To Settle Fraud
6 CommentsBy Ed Silverman // March 27th, 2008 // 5:58 pm
Otsuka American Pharmaceutical, the US unit of the Japanese drugmaker, agreed to pay more than $4 million to resolve allegations that it marketed the Abilify antipsychotic for off-label uses, according to the US Department of Justice.
The settlement resolves allegations that, from 2002 through 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis, although at the time, the FDA had not approved the drug for use in geriatric patients, teenagers or children. Last November, the FDA did approve Abilify for teenagers.
Otsuka developed Abilify in Japan and then entered an agreement with Bristol-Myers to co-promote the drug in the US. Bristol-Myers paid $515 million last September to settle the same allegations. Meanwhile, the whistleblower, Joseph Piacentile, a physician, will receive about $348,000 as his share of the federal recovery amount from the settlement, and an additional share of the state settlement amount.
Dan
I use to sell Pletal, which was at one time promoted by Otsuka, as a co-promotion agreement with Pharmacia many years ago. That company, Otsuka, sent the coolest stuff for promotion all the time when I was associated with them.
HorusCat
Dan,
This is totally off topic, but Pletal! I had forgotten about that drug, not being in PC offices anymore. Intermittant claudication, right?
Dan
Right, and I was a hospial rep at the time. Number one rep in the region for pletal, and never spoke of the med at all, as my focus was an IV antibiotic with my own company.
www.worldpharmanews.net
Pharmalot » Japanese Drugmaker Pays $4M To Settle Fraud…
The settlement resolves allegations that, from 2002 through 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis, although at the time, the FDA had not approved the drug for use in geriat…
HorusCat
Dan,
Isn’t that funny? The same say the V.A.Cant wins contests all the time…
This thread is a perfect illustration of the need for more flexible policies about off-label uses of drugs…Abilify is a great drug for kids. I hate to admit it, because I competed with them for awhile (not with child psychs, but in adult psych) and they kicked our ass, but it’s truly a miracle drug for some kids. Now I know I am going to get all the ripostes about the use of antipsychotics in kids, but the truth is, some kids need medication.
My son (autistic) takes Abilify. When we started him on it, the teacher actually called us to tell us how much his behavior had changed. He is still pretty quirky, but he is aware enough socially now to have friends (even a “girlfriend” at the age of 11)…and he can usually take a deep breath and stop himself from going over the deep end when something doesn’t go his way. Although he did get punched in the nose yesterday…
HorusCat
You know, I just reread the blurb and noticed the part about the “whistleblower” doc getting all that money…
I wonder if some docs ask off-label questions and push a rep to comment on off-label uses with the hopes of blowing the whistle and raking in the bucks…
I did wonder awhile back when I met a BMS rep who said he had been a long-term-care rep for Abilify…I was kind of confused, because they don’t have an indication…