The U.S Food and Drug Administration (FDA) is proposing a new rule which will allow generic drug makers to independently update the safety information on their product labels the same way brands do. The federal agency believes that the new rule can help quickly spread the new information to health professionals and patients who use generic drugs.
The new proposal suggests that generic drug makers can start the package inserts as soon as the FDA releases an announcement of any changes on the brand. However, the process still requires the generic makers to inform the brand that they are updating the product labels.
The federal agency is still to evaluate the proposal before it can decide on the changes and draft specific rules for the generic makers and the brands. This is to make sure that all rules will be aligned on the FDA-approved prescribing information.
"This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a press release. "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 current process permits the generic makers to update their product labels only after the brand completes its update. The former will then need to inform the FDA that it will be updating its labels too which needs to be approved by the brand too. The proposed change would allow the generic makers to file an update request to the FDA without waiting for the brand to finish updating its label.
Click here to see the proposal document of the labeling changes.