December 4, 2014

FDA Issues Final Rule on Pregnancy and Lactation Labeling

The Food and Drug Administration announced a final rule today that sets new standards for labeling information for prescription drugs and biological products. The rule, which was under consideration since 2008, requires that the labeling information include a summary of risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation.

Until now women and their healthcare providers had to make treatment decisions based on limited guidance. SWHR has written to the agency on the finalization of this rule in 2008 and 2011 and is pleased that it will now provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding and requires information on whether there is a patient exposure registry that collects and maintains data on the effects of the medication use in pregnant women.

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