Bill Aims To Eliminate Generic-Drug Labeling Delays

Law360, New York (October 15, 2009, 3:38 PM EDT) -- Sens. Jeanne Shaheen, D-N.H., and David Vitter, R-La., have introduced legislation intended to keep brand-name pharmaceutical makers from delaying competitors' attempts to roll out generic alternatives by giving generics makers an expedited approval path for labeling changes.

The Access to Affordable Medicines Act, S. 1778, submitted to the Senate on Wednesday, would give generic-drug companies a 60-day grace period after brand-name counterparts tweak label content in which to seek U.S. Food and Drug Administration approval for making similar changes to their own safety guidelines.

Current law...
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