Generic Drug Labeling Updates The Target Of FDA Proposal

Posted on November 12, 2013

In a bid to improve the safety of generic drugs, the Food and Drug Administration has proposed a new rule that would allow the makers of such medications to be privy to the same regulations as name brand products.  In doing, consumers and doctors alike could potentially gain access to pertinent information more quickly than before, allowing them to make the appropriate care decision.

The FDA relates how, if ultimately approved, the new rule would allow for generic drug makers to alter the label of a product should they receive new information related to its safety.  At the moment, the labels of generic drugs cannot be altered until such time that the name brand version of the drug receives the agency’s approval.

Just like the brand manufacturer, the producer of the drug would need to notify the FDA of the changes, and the FDA would have to give its approval to the alterations prior to finalization.  The sharing of information between brand and generic would become a two-way street, as the generic manufacturer would need to alert the brand name maker of the changes.

The hope is that the implementation of this new rule will prevent a delay in updated information that could lead a generic drug user to adhere to the wrong information.  By giving generic manufacturers more leeway to act on their own, safety could hopefully be better assured.

How Can We Help You?

If you have a legal matter you would like to discuss with an attorney from our firm, please call us at (310) 477-1700 or complete and submit the e-mail form below, and we will get back to you.

  • This field is for validation purposes and should be left unchanged.
  • This field is for validation purposes and should be left unchanged.
*Required Fields