Drug Maker ‘Jumped the Gun’ on Laxative Lawsuit

     (CN) – The 7th Circuit affirmed dismissal of a lawsuit accusing generic drug makers of labeling laxatives “prescription only,” even though the maker of the original drug sells an over-the-counter version. Judge Posner told MiraLAX maker Schering-Plough to wait until the Food and Drug Administration weighs in on the misbranding issue.




     Schering-Plough pioneered the oral laxative MiraLAX, which was originally available by prescription only. The FDA later approved generic versions and allowed Schering-Plough to sell an over-the-counter version of MiraLAX.
     Because the law forces generic drug makers to use the same labeling as the original, Breckenridge, Paddock and others included the phrase “prescription only” on their labels and inserts.
     The generic versions were, in fact, available by prescription only.
     But Schering-Plough argued that the labels misled consumers by implying that there weren’t any over-the-counter versions of the oral laxative.
     “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 wrote for the Chicago-based appeals court.
     “We agree with the district court, therefore, that Schering jumped the gun by suing before the FDA addressed the misbranding issue.”

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