Content and Format of Labeling for Human Prescription Drugs; Pregnancy Labeling; Public Hearing

Résumé

The Food and Drug Administration (FDA) is announcing a public hearing regarding requirements for the content and format of the pregnancy subsection of labeling for human prescription drugs. The public hearing will focus on the requirement that each drug product be classified in one of five pregnancy categories intended to aid clinicians and patients with decisions about drug therapy. Public comments and FDA's preliminary review of the pregnancy category designations for marketed drugs suggest that the categories may be misleading and confusing, may not accurately reflect reproductive and developmental risk, and may be used inappropriately by clinicians in making decisions about drug therapy in pregnant women and women of childbearing potential and also in making decisions about how to respond to inadvertent fetal exposure. The hearing is intended to elicit comments on the practical utility, effects, and limitations of the current pregnancy labeling categories in order to help the agency identify the range of problems associated with the categories and to identify and evaluate options that might address identified problems, and to hear the views of groups most affected.