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Consumer Group Supports FDA Drug Regulation Reform


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Consumer Group Supports FDA Drug Regulation Reform

Public Citizen, a consumer rights group, is petitioning the Food and Drug Administration to repeal obstacles blocking generic drug label modifications.

The organization asserts that generic drug manufacturers are not able to edit their labels through the prior-approval-supplements or changes-being-effected procedures that major medicine producers can leverage. Public Citizen views this as a disservice to consumers and is pressing the FDA to amend its regulations barring label modification.

"The advocacy group argues that revising FDA drug label regulations will allow generic manufacturers to leverage their information about 'product safety and effectiveness' and to revise drug labels to reflect risks identified by the manufacturers," RegBlog reports.

As the Public Citizen petition mentions, generic drug manufacturers account for a whopping 80 percent of the market, so ensuring labels are up-to-date is a crucial consideration.

The FDA recently highlighted the importance of having up-to-date safety warnings on medication when it voted to put caution labels on osteoporosis drugs to prevent long-term use.