Generic Drug Makers may Use Same Process as Branded Drug Makers to Update Labeling: FDA

The US Food and Drug Administration has proposed a new rule that could see generic drug makers make use of the same process as brand drug manufactures to update safety information on their labels if they receive any information of potential problems. The FDA said that generic drug makers can provide package warning inserts as soon as they receive information directly through the FDA or through announcements from the health agency.

However the generic drug makers will still have to inform the brands about changes to the product labels. The health agency said that the rule could speed up the spread of new information to health professionals and patients who make use of the generic drugs.

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use. More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date”, the director of the FDA's Center for Drug Evaluation and Research, Janet Woodcock said.


Source-Medindia