Schering-Plough Laxative Lawsuit ‘Jumped The Gun’
4 CommentsBy Ed Silverman // November 4th, 2009 // 7:36 am
That’s what the a federal appeals court judge ruled this week in affirming dismissal of a lawsuit accusing several generic drugmakers were accused of improperly labeling their laxatives as “prescription only” products. The 7th Circuit judge, Richard Posner, concluded that Schering-Plough should have waited until the FDA decided on whether any misbranding took place, Courthouse News Service reports.
The background is simple enough: Schering-Plough originated the MiraLax oral laxative, which was originally available by prescription only. The FDA later approved generic versions and allowed Schering-Plough to sell an over-the-counter version, the news service notes.
But generic drugmakers must use the same labeling as the original, so these companies included the phrase “prescription only” on their labels and inserts. The generics were, in fact, available by prescription only. But Schering-Plough argued the labels misled consumers by implying there weren’t any OTC versions.
“Schering has been coy about what it thinks the disclaimer should say, and its coyness makes us doubt that this is a matter that can be resolved intelligently without a decision by the FDA,” Judge Richard Posner ruled, Courthouse News writes. “We agree with the district court, therefore, that Schering jumped the gun by suing before the FDA addressed the misbranding issue.”
Anne PME
Dear Ed,
How much sugar and caffeine do you think that these people ingested before filing this lawsuit?
How much sugar and caffeine (or other potential mood altering activities like shopping sales or watching football for example) do you think that it will take to get the FDA to address this?
I wish that the new FDA appointees and others who are involved in safety efforts could concentrate on dealing with H1 N1, the beef recall and other serious safety issues. Instead, it seems like all of this and more gets thrown at these employees and appointees all at once. I worry that some FDA employees and appointees will loose their sense of humor and quit, and want them and others to know that we really appreciate and thank them for their effort and patience.
Anne
Former Pharma Marketing Director
Anne,
Seems H1N1 is taking up importance space that MAYBE it shouldn’t…..
Swine Flu
Anne PME
Thanks FPMD.
Do you think that maybe the FDA, HHS and other agencies are using H1N1 as type of practice session for a more serious public health threat? Also, is it me or are you also a little surprised that no one is tying H1 N1 to health care reform efforts and the need to have universal HC?
Former Pharma Marketing Director
Hi Anne,
Let’s follow that logic….
Let’s say this was some sort of practice run. The question is, is it ethical to dupe the legions of citizens into having something injected in their body that they may or may not need, but according to the Cochran Institute they probably do not need, and who knows what it will do to them later, maybe ensure that they are all “return” consumers with one health care ailment or another? Then on this premise, no it is not ethical. You cannot even argue that it is for a patients own good, or you could not argue that it is good for the majority, there is no way to slice and dice this to make it ethical…
But, let’s say one did have to test some hypothetical system so that we can know in the future if it will work against some other threat. Well, then it is like a clinical trial of sorts, you calculate what size cohort you need and you voluntarily sign up people to participate. You do not need to tell them the full extent of what you are doing, but you can tell them that for a few days they are in a trial. Then they are in clinical trial centres where TV ads and “fake” news commercials are simulating a pandemic, then see how many sign up for the vaccine and how smoothly the inoculation process goes. This is just one way, but if I spent time thinking about it I would come up with several others.
The point is, no, no, there is nothing that you could come up with that would justify this.
And yes, it is really amazing that people are not making the obvious health reform link….