HHS Floats Proposal To Upend Generic-Drug Labeling Regs

Law360, New York (July 3, 2013, 7:51 PM EDT) -- The U.S. Department of Health and Human Services intends to propose allowing generic drugmakers to alter the warnings that accompany their products, the agency said, a rule that could effectively undo the U.S. Supreme Court's landmark Mensing decision.

The HHS expects a notice of proposed rulemaking to be released by the end of September, it said in a July 3 entry in the Unified Agenda, a document released twice a year that outlines federal agencies' regulatory plans. The agency had previously only indicated it was considering...
To view the full article, register now.