NPWH at the Coalition to Advance Maternal Therapeutics Stakeholder Meeting

On Thursday, December 3, NPWH along with 15 stakeholders attended the meeting, including American Academy of Pediatrics, American Congress of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, Society for Women’s Health Research, and Association of Women’s Health, Obstetric and Neonatal Nurses, American College of Nurse Midwives attended the Coalition to Advance Maternal Therapeutics Stakeholder Meeting.

The meeting focused on the new FDA pregnancy and lactation labeling rule with a history of pregnancy labeling, problems with the old system, processes used to develop new labeling rule, and examples of the requirements of the new labeling rule. The CDC presented on the Treating for Two initiative, the magnitude of medication use in pregnancy, and the objectives of the program. The objectives of Treating for Two include:

  1. Reduce fetal exposure to tetratogenic medications,
  2. Prevent birth defects and other adverse pregnancy outcomes,
  3. Improve women’s health by informing safe and effective treatment of conditions during pregnancy and the reproductive years
  4. Increase confidence in using medications during pregnancy that are not associated with adverse outcomes

Learn more about the Treating for Two initiative here.

NPWH Attends FDA Office of Women’s Health — Women’s Health Update Meeting 

The meeting gave women’s health organizations the opportunity to discuss their Women’s Health Priorities for 2016. One of the key points of the meeting was a discussion about the need for women from diverse backgrounds in clinical trials. The FDA is launching an awareness campaign and NIH developed an outreach toolkit for clinical research. The FDA requested feedback from meeting attendees for ideas on how they can collaborate with women’s health organizations, like NPWH, to get more women from diverse backgrounds involved in clinical trials. The evolution of women’s health at the FDA was also addressed.