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FDA Considers Timeline for Safety Labeling Changes After Approval of Prescription Drugs

Tuesday, December 20, 2011
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is requesting comments no later than Feb. 21, 2012, on specific issues related to its authority under the Federal Food, Drug and Cosmetic Act to require or order safety labeling changes for approved prescription drug products based on new safety information that becomes available after a drug product is approved.

The Food and Drug Administration Amendments Act of 2007 authorizes FDA to require labeling changes when it becomes aware of new safety information it believes should be included in the labeling of an approved drug product. Before the enactment of this law, if FDA believed that a labeling change was necessary to address safety information newly identified after the approval of a drug product it would ask the application holder to make the appropriate labeling changes. In most cases application holders responded by negotiating appropriate language with FDA staff to address the concern and then submitting a supplement or amended supplement to obtain approval of the changes. FDA routinely asked applicants to submit supplemental applications to revise the labeling of approved products, but it lacked the authority to compel changes to product labeling based on new safety information.

Under the FDAAA, FDA is now authorized to require and, if necessary, order application holders to implement safety labeling changes to reflect new safety information. Although the statute provides specific and relatively short timelines for the submission and review of FDAAA-required safety labeling changes following a notification or order from FDA, it does not include specific deadlines for how soon the revised labeling must be incorporated into the packaging of the product that is offered for sale, or into other labeling.

FDA is therefore interested in hearing from application holders, manufacturers, distributors and other stakeholders about their experience with and views on the practical implementation of revised product labeling, including how factors in the following three categories may affect implementation: (1) drug manufacturing and packaging, and printing labels and other labeling; (2) supply chain issues; and (3) other issues. FDA may use the information received to develop draft guidance for industry regarding timeframes for revising product labeling following the approval of safety labeling changes and may apply these timeframes to particular safety labeling changes.

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