Abbott Pays $22.5M To States Over TriCor
2 CommentsBy Ed Silverman // January 7th, 2010 // 4:00 pm
The drugmaker was accused of conspiring to block generics of its TriCor cholesterol med - a $1 billion seller - from becoming available by making minor changes in formulation. Lawsuits were previously filed by a group of generic drugmakers, retailers and wholesalers, including Teva Pharmaceuticals, Walgreen and Rite-Aid, which Abbott settled for $184 million in November 2008 (see here).
The multi-state lawsuit, which was filed in March 2008, alleged Abbott and Laboratoires Fournier, which discovered the drug, made the changes to TriCor knowing there was no clinical benefit, but didso in order to prevent pharmacists from dispensing less-expensive generic versions. The states also charged the drugmakers thwarted generics by filing baseless patent-infringement lawsuits against generic rivals (here is the settlement agreement).
“These companies deprived taxpayers, state agencies, and consumers of a fair marketplace that would have lowered prices by offering less expensive generics,” New York State Attorney General Andrew Cuomo, says in a statement. “They manipulated the market causing New York and its citizens to pay more, and that cannot be tolerated. Because of this settlement, millions of dollars will now be distributed into New York State programs.”
shytown
This has been going on for YEARS.
ISOMeR TECHNOLOGY has extended many a patent life. It is good to see the meds with no real advantage are being investigated.
I will be the 1st to acknowlege that having options open for dr.s is important. However, me-too drugs that are obviously just trying to extend their product life cycles should not get approved. IE: Clarinex(Clariton), Focalin(Ritalin). How about setting up efficacy thresh-holds that a current nda must meet to get addl pat extensions for these older drugs.
If a drug can show that it can do better than it’s original, than I say give it an extension.
If it cannot, which I am afraid most drugs fall into this catogory, then do not grant it an extension. It seems pretty simple to me. Am I wrong?
I know this much, Focalin’s efficacy was the exact same as Ritalin. Yet, we were able to spin dr.s off of Ritalin to Focalin with the implied message that the drug was cleaner, yet no studies showed less side effects and even less efficacy. Let’s see your pro-pharma people defend that one!
pharmavet
Even an NDA for a brand-name albeit “me-too” drug doesn’t have to prove itself better than the original. It just has to beat placebo to be approved. This is consistent with the FDA’s core philosophy that it is not in the business of regulating the practice of medicine. Even with drugs such as ACE inhibitors, they all do about the same thing, but individual doctors prefer ceratin ones, and patients may tolerate one better than another. If NDA’s or sNDA’s were held to a comparative efficacy standard, we would not have the wide range of therapeutic options open to both doctors and patients.