The U.S. Food and Drugs Administration proposes allowing generic drug manufacturers to update safety labels when new information about potential risks is discovered.
According to a summary posted Wednesday on the Office of Management and Budget website, the U.S. Food and Drugs Administration proposes allowing generic drug manufacturers to update their drug safety labels when new information about potential risks is discovered.
Currently, generic manufacturers, unlike branded manufactures are not allowed to update their drug labels even if they learn of a potential safety issue that is not included in the existing label. In the event that brand-name equivalent manufacturers make a similar change, generic manufacturers may upgrade their safety label after seeking permission from the FDA. A Public Citizen report lists 434 generic drugs for which no comparable brand-name product exists.
The new proposal would require all manufacturers of the same drug to carry consistent labeling revisions after the FDA approved a revision by one company.
"Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience and complete data that is needed to make these decisions," USA Today quoted Ralph Neas, president of the Generic Pharmaceutical Association as saying.
The new rule comes a month after the Supreme Court ruled that generic manufactures cannot be held responsible or taken to court for any damage caused after using their products. The court also ruled that a state's law cannot run against federal laws on prescription medications whose design has been approved by the FDA.
