Proposed Changes to the Pregnancy Section of Labels for New Drugs and Biologic Products, by S. Kweder and A. Scialli. It is the consensus of these subcommittees that before writing a labeling proposal, it is important to discuss core principles that communicate our position on the pivotal issues in the development of new guidance for pregnancy labeling. We feel that these core principles should be applicable to any pregnancy labeling proposal that is developed. We urge the FDA to adopt them as guiding principles for your works on this project.
Secondary customers are pharmacists and pregnancy counseling groups.
Physicians and other health professionals need better guidance in interpreting the details of preclinical findings and assessing the potential risk based on those findings. We believe that these customers want bottom-line advice presented in a standardized format on the use of a drug in pregnancy. Bottom-Line Advice should be provided using Summary Statements, not categories or standardized language. Custom-written dialog, within general guidelines, is recommended. This recommendation should make a conclusive statement about use in pregnancy.