Generics may have to supply their own safety information, if a new FDA proposal goes through. Depending on perspective, drugmakers will either be liberated or burdened with the proposal to allow generics manufacturers to update their safety labels even if the branded version of the drug has not.
Current rules prevent generics makers from creating labels that do not match branded versions, and even if branded labels change, the generic label has to get an all-clear from the FDA before it can make a change. Brand manufacturers, however, now have a two-part update process: manufacturers can modify their labels and then tell the FDA what’s been changed, and the FDA can provide a retroactive rejection or approval.
The FDA’s new proposal would give generics makers the same labeling authority as their branded peers. The FDA said in a statement Friday that the proposal would “speed the dissemination of new safety information about generic drugs to healthcare professionals and patients.”
Health and Human Services says in the introduction to the proposed rule that the change would “create parity” between branded-drug manufacturers and generics makers. The HHS proposal also explains why the new rule is surfacing: generics now account for 80% of dispensed prescription drugs and “brand-name manufacturers may discontinue marketing after generic-drug entry.”
The new rule would allow/require generics makers to stay abreast of known risks as they surface. Current rules allow generics makers to wait things out until, and if, issues surface and brand manufacturers address them. The proposal would also require generics makers to alert branded manufacturers of label changes.
Not everyone is on board with the proposed change. The Chamber of Commerce says the new rules would increase the cost of generics, telling Regulatory Focus that a new rule would require research and a label review process. RF notes that it could also create a new liability for generics makers: if the companies are given the ability to update their labels and ignore risks associated with the treatments, they could potentially be liable if a patient is harmed and the risk not disclosed.
