FDA Issues Serious Warning For Abbott’s Depakote
5 CommentsBy Ed Silverman // December 3rd, 2009 // 6:38 pm
The agency says the epilepsy can cause an increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies. And the FDA warns that women of childbearing potential should only use valproate if it is essential to manage their medical condition (here is the FDA statement).
The drug has a sordid profile: it already carries a strong “black box” warning that it may cause birth defects (prescribing info) and a study in The New England Journal of Medicine linked it to lower IQs in the children of women who took the drug. In June, the FDA recommended added study of delayed development reported in children whose moms took Depakote.
The warning comes just one month after Abbott Labs disclosed the US Department of Justice is investigating its sales and marketing for the pill, which is used to treat bipolar disorder, seizures and migraines. The government wants to know whether Abbott violated civil and/or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute in connection with Medicare and/or Medicaid reimbursement to third parties (back story).
Hat tip to Furious Seasons
patrons99
It’s about time! Better late than never. DOJ has all the legal tools it needs, and then some!.
While I’m not a lawyer, I have to believe that, at some point, a RICO action could be brought against Pharma (not necessarily against Abbott). Aren’t all of the elements present? a RICO enterprise, predicate mail and wire frauds, conduct and control, and concerted action (and an agreement) to violate the substantive RICO act.
Condor
Yes, Patrons99 — Most of these larger DoJ investigations lead to civil RICO actions.
Merck is facing at least two; Pfizer — at least three; Lilly at least one or two. It will be years before an outcome, and all along — the revenue continues to pour in.
And so it goes. I do not condone it — but it is just the way it works out. Pharma may be the most-well insulated enterprise we’ve ever seen in the US — see the other current thread, on Pfizer and J&J’s plea negotiations, on that score.
Namaste
patrons99
Wow! Thanks, Condor, for sharing your legal insights. Have there been any criminal RICO actions against Pharma? If so, why would a criminal RICO conviction not result in debarment from Medicare? I notice your use of the word “enterprise” [i.e., "pharma may be the most well insulated enterprise we've ever seen in the U.S."]…that word smacks of RICO. It’s an illegal criminal enterprise. Perhaps, the CRO’s should also be held accountable, for quite often CRO’s actually “conduct” the fraudulent research. “Conduct” is another one of those RICO-associated words (I believe it’s one of the substantive RICO violations, Section 1962(c)). Patients have and died and are dieing. I just don’t see how they can continue to keep plea-bargaining. Drug development and drug marketing are completely corrupt. The public doesn’t have a clue as to what’s going on.
Condor
Other than in TV-Infomercial Diet pill settings (i.e., not big pharma), I am not aware of any use of CRIMINAL RiCO prosecutions.
I know that US Attorneys’ Offices often look at it, conduct the investigation toward that possibility, but often they find the “beyond a resaonable doubt” proof hard to come by — doubly so, when coupled to the required proof of specific intent to commit a felony (the standard is much higher for criminal RICO, compared to civil RICO — where it is a simple “more likely than not” standard of proof).
So it goes. But well-met, just the same, patrons99!
Namaste
Customer
This isn’t news to me. I knew when I was taking the drug over 12 years ago that it had this potential. I was on it for the first four weeks I was pregnant with no ill effect. I was switched off when I found out I was pregnant. My doctor mentioned all these risks to me before I took the first pill. People need to take some responsibility and ask questions and look for answers. None of this information was kept secret.