FDA PROPOSES NEW RULE ALLOWING GENERIC DRUGMAKERS TO CHANGE LABELLING
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By: Kelda Doherty
The website of The Office of Management and Budget has revealed that the FDA is planning on revising regulations and implementing a new rule which would allow generic drug makers to update and alter their labeling to contain any new information which could affect consumers health. We cheer this development as we are currently prevented from litigating against generic drug manufacturers.
Currently, if a generic drug maker is alerted to new potential side effects, they are not required to change their labels. As it stands, a generic drug label is only required to mirror that information and health warnings of its brand version drug label.
The impact of allowing a generic drug to alter its label would mean that new information of potentially harmful effects would not go unnoticed and could be communicated to consumers on an updated label. This in turn would also mean that generic drug makers could face the same type of product liability in relation to inadequate labeling as brand-name drug makers.