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Policy Proposal Would Allow Generics To Modify Labels

Regulations Stop Generics From Changing Labels

Currently, manufacturers of generic drugs are not permitted to make changes to their product labels. However, the U.S. Food and Drug Administration (FDA) made its intent to reconsider regulatory barriers known after officials spoke with Alison Frankels, a reporter for Reuters.

When contacted, the FDA responded that it was seriously considering revoking the policy regulation that bars generics from altering their labels like brand-name manufacturers can. The change would allow for label adjustments under appropriate circumstances, the FDA told Reuters in its response email. Generic drug-makers are legally required to post the same warning labels as their brand-name counterparts, which they cannot change.

FDA Seeks Public Input On Possible Labels Overhaul
Before the policy change affecting labels goes further, the FDA intends to open up a channel for discussion to allow consumers to give their feedback regarding the proposal. Generic producers were formally barred from changing their product labels after the United States Supreme Court issued a ruling in 2011 that held anyone claiming injuries from generic products cannot sue these companies for failure to warn of any drug-related dangers. The case exempted generic drug companies from legal recourse because they are not in control of what warning labels must be displayed on medication.