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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.