FDA proposes rule to speed dissemination of new safety information about generic drugs

FDA takes action to speed safety information updates on generic drugs

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.

Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA's review of the change, in the same way brand drug manufacturers do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change.

The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same 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. "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."

Currently, generic manufacturers must wait to update product safety information until the corresponding brand name product has received approval to update its safety information. Brand drug manufacturers are allowed to independently update and promptly distribute updated safety information by submitting a "changes being effected" (CBE-0) supplement to FDA. Generic manufacturers must notify the FDA of new safety information, and wait for the FDA and the brand manufacturer to determine the updated labeling, which may result in a delay in getting new information to health care professionals and patients.

Under current law, generic and brand drug manufacturers are required to promptly review safety information about their drugs and comply with the FDA's reporting and recordkeeping requirements. When new information becomes available that causes the product labeling to be inaccurate, all drug manufacturers must take steps to update the labeling.

To enhance transparency while the FDA is reviewing the change and to make safety-related changes to drug labeling quickly available to health care professionals and the public, the FDA plans to create a web page where safety-related changes proposed by all drug manufacturers would be posted. Members of the public could subscribe to receive updates.

The FDA is seeking public comment on the proposed rule announced in a Federal Register notice today.

FDA-approved generic drugs are copies of brand drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.