FDA proposes new pregnancy categories for prescription label

May 30, 2008

A new three-category label is in the works for pregnancy and breastfeeding information.

A new proposed rule that will change the way a prescription label presents pregnancy and breastfeeding information has been issued by the Food & Drug Administration. If enacted, the revision would remove the current letter categories from the pregnancy section and reformat the information into three sections. A “Fetal Risk Summary” would provide a risk conclusion based on the available data and would be followed by a summary of the most important data on the drug’s effects. The “Clinical Considerations” section would include discussion regarding the risk to mother and baby, provide dosing information, and address handling of potential complications. The third and final section, “Data,” would describe, in detail, the data used to form the conclusion statement in the “Fetal Risk Summary.” The lactation section of the label would follow the same format. According to the FDA, newly approved drugs would utilize the new structure immediately while older drugs would be phased in gradually. Comments on the new proposal can be submitted electronically for 90 days to the Federal Documents Management System eRulemaking portal.

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