Resources for You
Maternal Health Team
The Maternal Health Team (MHT) is part of the Pediatric and Maternal Health Staff located in the Immediate Office of the Office of New Drugs.
Our mission is to help women and their healthcare providers make well informed medicine choices when medicine is needed during pregnancy or breastfeeding.
The Maternal Health Team aims to:
- Improve drug labeling information related to the use of drugs during pregnancy and lactation.
- Develop regulations, guidance documents, and procedures related to how drugs are labeled for use during pregnancy and lactation.
- Respond to consult requests from review divisions in the Office of New Drugs related to pregnancy and lactation.
- Encourage research on medicines used by pregnant and breastfeeding women.
- Help women and their healthcare providers make well informed medicine choices when medicine is needed during pregnancy or breastfeeding.
- Working with other government Agencies on pregnancy and lactation initiatives.
- Developing regulations, guidance documents, and procedures related to the use of medicines during pregnancy and lactation.
- Assessing risks of drug exposure during pregnancy and lactation.
- Identifying special government employees with expertise in human teratology, birth defects, and obstetrical pharmacology.
- Encouraging research in women using medicines during pregnancy and breastfeeding in order to improve drug labeling and evidence-based clinical decision making.
- Responding to consult requests from drug review divisions related to:
- Pregnancy exposure registries
- Pregnancy and nursing mothers sections of labeling
- Pregnancy prevention risk management programs
- Protocol review for studies in pregnant and lactating women (IND/NDA/Phase IV)
- Evaluating published case reports/series and epidemiologic studies of possible drug-induced adverse pregnancy outcomes or effects in breast-fed infants.
Pregnancy and Lactation Labeling Initiative
- On May 29, 2008, the FDA published the Proposed Pregnancy and Lactation Labeling Rule. The Proposed Rule will amend current regulations on the format and content of the Pregnancy, Labor and Delivery, and Nursing Mothers subsections of labeling. For more information on the proposed rule, please visit the Pregnancy and Lactation Labeling website.
- As of February 2011, the Final Rule is in the writing and clearance process. This process requires identification and consideration of all issues raised in the public comments. A working group was convened in 2008 to work on these issues and determine whether the proposed regulation should be revised (and if so, how) based on this feedback, the current state of the science, and FDA's current regulatory authority. The rulemaking process has many necessary and important steps. The Pregnancy and Lactation Labeling Rule is an Agency priority and is moving through this process as efficiently as possible. When the Final Rule publishes, there will be a draft Guidance for Industry and information for healthcare practitioners about these important changes.