Labeling for generic drugs must always remain the “same as” that of listed brand name drugs and generic drug manufacturers cannot unilaterally change labeling without prior FDA approval. Following an FDA requirement, generic manufacturers revised the labeling for a drug, metoclopramide, regarding the risk of tardive dyskinesia. A patient who developed tardive dykinesia after taking such generic drugs for four years sued, asserting that the generic manufacturers failed to adequately warn about the association between long-term ingestion of the drug and movement disorders. The generic drug manufacturers argued that the patient's claims were preempted by federal law. According to the U.S. District Court for the District of Minnesota, under abbreviated new drug application procedures, a generic manufacturer is required to put exactly the same language on its warning labels as the listed drug. Any duty to unilaterally heighten the warning labels would directly conflict with federal law requiring that generic labels be the same as listed drug labels, and there is no legal duty to propose revised labeling or undertake independent communication with health care professionals. The company's motion to dismiss was granted.
SOURCE: Mensing v. Wyeth, Inc. d/b/a Wyeth
For more information on this and related topics, consult the CCH Food, Drug and Cosmetic Law Reporter.
Visit our News Library to read more news stories.
Food, Drug and Cosmetics Law Reporter
Everything you need to know about Food and Drug Regulations.Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Learn More » |
Medical Devices ReporterAccess the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices. Learn More »
|