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Capitol Health Call
March 12, 2014

Proposed FDA Generic Drug Labeling Policy Questioned

Author Affiliations

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(10):1005. doi:10.1001/jama.2014.1175

A group of House and Senate Republicans sent a letter to Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, questioning the FDA’s proposed regulation to allow generic drug companies to unilaterally change their drug labeling information.

On November 8, 2013, FDA officials announced the proposed regulation ( The agency said the measure would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling. Currently, before generic manufacturers can update safety information for a product, they are required to wait until the manufacturer of the corresponding brand-name product has received such approval.

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