By shelving a proposed federal rule to allow generic drug makers to update the warning labels on their medicines, the U.S. Food and Drug Administration (FDA) settled a contentious issue and largely shielded the companies from potential litigation.
The debate sprang from a 2011 U.S. Supreme Court ruling that stated generic drug manufacturers cannot be sued for failing to warn consumers about new safety concerns because federal law requires them to use the branded drug’s labeling, which they have no authority to modify – unlike a drug’s original brand-name sponsor. In 2013, the FDA proposed a rule that would permit generic manufacturers to change labels (a rule widely opposed by the generic industry), but the recent decision drops that plan.
Critics argue that the double-standard for brand-name and generic companies leaves consumers vulnerable and unaware of new, potentially deadly or debilitating side effects. In The Wall Street Journal, FDA Commissioner Scott Gottlieb, MD, defended the decision in a statement: “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities … [and] might have raised the price of generic drugs.”
Source: The Wall Street Journal, December 13, 2018.