Pfizer On The Hook For Off-Label Generic Use
9 CommentsBy Ed Silverman // March 22nd, 2008 // 9:15 am
A Philadelphia judge has ruled that Pfizer may have a legal duty for money spent on the generic version of Neurontin, according to The Legal Intelligencer. The brand-name drug, you may recall, was approved as a supplemental med for epilepsy, but Pfizer and Warner-Lambert - which Pfizer acquired - paid a $430 million fine four years ago for off-label marketing. And the generic, known as gabapentin, was made by other manufacturers.
The legal question presented in a Pfizer motion for partial summary judgment was whether a drugmaker, which “negligently or intentionally perpetrates a fraud upon the medical community” by the off-label marketing of its brand-name drug, can be held responsible for money paid to other drugmakers that make the generic equivalent of the brand-name drug, wrote Philadelphia Common Pleas Judge Mark Bernstein. And so he let stand claims of negligent misrepresentation, negligence and intentional misrepresentation concerning the generic that was made by other manufacturers.
The judge wrote that it was foreseeable that marketing Neurontin for off-label use would increase the demand for a generic version, according to the Intelligencer. Pfizer estimated that Neurontin would lose between 65 percent to 95 percent of its market once Neurontin patents expired, so Pfizer proposed marketing its own generic, Bernstein noted.
“I believe it’s the first opinion in the country that expressly says that a brand-name manufacturer can be liable for the money spent on drugs manufactured by a third-party manufacturer,” plaintiffs attorney John Weston tells the paper. “There are not a huge number of cases that address this.”
Justice in Michigan
Interesting. As we now know, the key point of the off-label promotion efforts were to save those approvals for Lyrica when Neurontin went off patent. Would make Lyrica look more “innovative” and thus much more competetive with generic gabapentin. So, WL/Pfizer would have cake and eat it too. Makes this ruling ironic, to say the least.
Some will know there was discussion of the N case in the Melody P. thread, including the FDA’s summary re: motivation as well as tactics (way beyond “speech”). The Justice Dept. summary Ed links is that much more complete.
Atlex
The funny part is that a number of payers including Pennsylvania Medicaid and some large insurers mandate the off-label use of gabapentin for fibromyalgia before Lyrica can be used on-label. This seems to be a Catch 22.
Justice in Michigan
Interesting, Atlex. To me, it sounds consistent. The payers are saying, in essence, that the two meds can be considered interchangeable unless demonstrated otherwise for a particular pt. Thus, use cheaper generic gabepentin first.
As I understand it, the core of the Neurontin scam was not that it didn’t work for a range of uses (it clearly does), although not for all for which it was promoted. It was the decision to not seek approval for those uses, so Lyrica (”son of Neurontin” in the DOJ report) would look a lot newer than it is.
Lisa Van S
Justice
Since Lyrica,..as you put it is the son of neurontin, would we see suicide and attempts as a side effect?
www.worldpharmanews.net
Pharmalot » Pfizer On The Hook For Off-Label Generic Use…
The legal question presented in a Pfizer motion for partial summary judgment was whether a drugmaker, which “negligently or intentionally perpetrates a fraud upon the medical community” by the off-label marketing of its name-brand drug, can be held r…
Justice in Michigan
The phrase “son of Neurontin” is not mine; it comes from the Department of Justice report on the Neurontin case.
Here is the relevant paragraph from that report which is linked in Ed’s post:
“These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin, which was expected to go off-patent soon, to compete with a “son of Neurontin” drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses.”
Thus, the issue is not whatever differences can now be shown between the two drugs. The relevant issue for this case was what the Department of Justice discovered was Warner-Lambert’s long-range marketing plan, and how promoting, but not applying for, uses fit into it.
USA
I’m fine with the Pfizer move. Why Not? Pfizer puts there research and money into discovering great Med’s and some out of the country scab generic company steals there product
to sell at a lower price. Why not buy Pfizer’s generic’s? Americans should want to see Pflizer survive not go under. There stock has been crushed over time. Were will all those NY’ers work if they go under? The Generic companies are based in India etc, a bit of a drive from the Big Apple.
Jack2
I don’t think a company should be forced to pursue approval for an indication.
Justice in Michigan
Jack2 - Fascinating view. So would you require any efficacy/safety studies for anything? How would you decide what indications were on the PI and what weren’t? (If there even was a PI.)
Or would companies be allowed to promote for whatever conditions they chose, with no requisite science that is reviewed to back it up, once drug was approved for _something_. From there, all up to docs and pts?
Genuine questions.