FDA Standards for Drug Labeling: Pregnant and Breastfeeding Women

The FDA published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will 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.


The final rule replaces the current product letter categories – A, B, C, D and X – used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.


“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”


The final rule requires the use of three subsections in the labeling titled “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential” that provide details about use of the drug or biological product. The detailed subsections must include a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary and relevant information to help health care providers make prescribing and counseling decisions. The “Pregnancy” subsection provides information relevant to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus, and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug or biological product. Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not required until now. The “Lactation” subsection provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child. The “Females and Males of Reproductive Potential” subsection includes information about pregnancy testing, contraception, and infertility as it relates to the drug. This information has been included in the labeling, but there was no consistent placement for it until now.


The “Pregnancy” and “Lactation” subsections will also include three subheadings: “risk summary,” “clinical considerations,” and “data.” These subsections provide more detailed information regarding, for example, human and animal data on the use of the drug, specific adverse reactions, and information about dose adjustments needed during the pregnancy and post-partum periods. It will apply not just to new drugs approved from now on, but also to older drugs approved since 2001 that have been marketed for years without their labeling being updated to incorporate important new information related to pregnancy and lactation.


There are over six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy and breastfeeding. Women may also need to take medications for new or acute conditions that may occur during pregnancy or breastfeeding. The new labeling format and requirements reorganize information and are structured to help inform health care professionals’ prescribing decisions and the counseling of patients using prescription drugs.


The final rule is part of a broad effort by the agency, which began with the “Physician Labeling Rule,” to improve the content and format of prescription drug labeling.


The rule finalizes many of the provisions in the proposed rule that the FDA issued in May 2008, and will be in effect as of June 30, 2015. Once the final rule is in effect, newly approved drug and biological product applications will be required to use the new format immediately, while the new labeling content and format requirements for previously approved products subject to the “Physician Labeling Rule” will be phased in gradually.


The FDA also is issuing draft guidance for the industry to help drug and biological product manufacturers comply with the new labeling content and format requirements. The draft guidance provides a detailed description of how the labeling is to be formatted subsection-by-subsection, noting the type of information that should be included under each heading.


See the FDA Announcement


See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability (to be published January 7, 2015).


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication