GOP Lawmakers Rip FDA's Generic-Drug Labeling Overhaul

Law360, New York (January 23, 2014, 7:08 PM EST) -- Congressional Republicans on Wednesday sharply criticized the U.S. Food and Drug Administration's controversial plan to let generic-drug makers independently change their warning labels, saying they have "grave concerns" that the move would drive up costs and conflict with federal law.

In a lengthy letter, GOP lawmakers asserted that the FDA's proposed rule runs contrary to the Hatch-Waxman Act’s so-called sameness requirement, which dictates that generic and brand-name drugs share identical labels.

Regulators have argued that the inability of generics makers to unilaterally revise labeling reduces their...
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