Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
SUMMARY
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling.
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 will provide 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 will provide 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 will include information about pregnancy testing, contraception and about infertility as it relates to the drug. This information has been included in 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 subheadings will provide more detailed information regarding, for example, human and animal data on the use of the drug, and specific adverse reactions of concern for pregnant or breastfeeding women.
Sources and more information
- FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products, FDA News Release, December 3, 2014.
- Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, federalregister.gov, December 04, 2014.