By Jeff Overley (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 incentive to look for new risks. Also, because many brand-name products are pulled from the...
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