Generics Primed To Fight FDA On Labeling Flexibility

Law360, New York (February 12, 2013, 8:40 PM EST) -- The U.S. Food and Drug Administration is considering making generic-drug makers responsible for the warnings on their product labels, but attorneys say the industry may attempt to avoid liability by attacking the agency's ability to issue such a rule without approval from Congress.

The FDA confirmed Monday that it may allow generics makers to alter their labeling “in appropriate circumstances.” The federal government first had indicated the agency was considering such a move in a footnote to an amicus curiae brief filed to the U.S. Supreme...
To view the full article, register now.