The FDA proposed a new rule to speed the distribution of new safety information about generic drugs to healthcare professionals and patients by allowing generic manufacturers to use the same process as brand drug manufacturers to update their safety information in the product labeling.
This proposal would allow generic manufacturers to independently update package inserts with new safety information before the FDA’s review, as brand manufactures currently do. Generic manufacturers would also be required to inform the brand manufacturer about the change.
This labeling change would then be evaluated by the FDA and the agency would make an approval decision on the generic drug labeling change and the respective brand drug labeling change at the same time. This would result in both products having the same FDA-approved prescribing information.
Under current procedures, generic manufacturers are required to wait to update product safety information until the corresponding brand product has received approval to update. Generic manufacturers have to alert the FDA of any new safety update then wait for the FDA and brand manufacturer to approve that updated labeling. The wait may result in a delay in conveying the new information to healthcare professionals and patients.
During this time of review, the FDA plans to create a web page where safety-related changes proposed by all drug manufacturers would be posted.
For more information call (888) 463-6332 or visit the FDA’s Federal Register notice.