FDA's Proposed Rule on Pregnancy and Lactation Labeling

Will include two subsections: one on pregnancy and one on lactation. Each subsection will include three principle components: risk summary, clinical considerations, and a data section.

1. Risk Summary: Four types of developmental abnormalities addressed (based on animal or human data).

• Structural anomalies
• Fetal and infant mortality
• Impaired physiologic function
• Alterations in growth

2. Clinical Considerations: address three main topics important when counseling with, and prescribing for, women who are pregnant, lactating, or of childbearing age.

• Inadvertent exposure: known or predicted risk to fetus (date on dose, timing, and duration of exposure)
• Prescribing decisions for pregnant women:
  • Risk to the pregnant woman and the fetus from the disease the drug is indicated to treat
  • Dosing adjustments during pregnancy
  • Adverse reactions unique to pregnancy associated with use of the drug. 
  • Any interventions that may be needed (e.g., monitoring blood glucose for a drug that causes hyperglycemia in pregnancy)
  • Any complications in the neonate associated with drug use, including severity and reversibility, and interventions needed
• Drug effects during labor or delivery:
  • Effect of the drug on the mother; the fetus/neonate
  • Duration of labor and delivery
  • Possibility of complications, including needed interventions; and the later growth, development, and functional maturation of the child

3. Data Section:

• A description of the types of studies
• Animal species used
• Dose exposure information  (animal doses described in terms of human dose equivalents)
• Nature of any identified fetal developmental anomalies and other adverse events
• For animal data, an explanation of what is known about the relationship between drug exposure and mechanism of action in animals versus humans.

Reference: US Department of Health and Human Services