The FDA is working to change existing drug regulations in regard to use in pregnant women. With these changes, drug companies will have to provide evidence that a drug is safe for both mother and fetus before it can receive proper labeling.
For its part, the NICHD has started the Obstetric-Fetal Pharmacology Research Unit program to support new research on the safety and effectiveness of medications used during pregnancy. This new research effort will rely on clinical sites around the country to conduct clinical trials in pregnant women to: - Find out how drugs affect pregnant women, at different stages of pregnancy;
- Figure out what effects, if any, these drugs have on the growing fetus, at different stages;
- Determine safe and effective doses for medications used in pregnant women; and
- Inform health care providers about drug testing in pregnant women and which drugs have been proven safe and under what circumstances.
The NICHD will sponsor a scientific workshop on the Obstetric-Fetal Pharmacology Research Unit program in late 2003, to develop a research plan and discuss partnering with professional organizations to help this research advance. The NICHD and the FDA remain committed to this important work. Reproductive Health in Women with Disabilities Through its National Center for Medical Rehabilitation Research (NCMRR), the NICHD is working to understand the issues that women with disabilities face, in terms of their reproductive health. Much of this research occurs within the projects that address the overall health of and health promotion for women with disabilities.
Some of the research projects supported by the NCMRR include: finding body responses to spinal cord injury that are unique to women; understanding how spinal cord injury impacts a woman's sexual responses and sexual health; learning how arthritis and multiple sclerosis affect women's reproductive health; realizing how menopause and the stages of menopause are unique in women with disabilities. In addition, the Center for Research on Women With Disabilities (CROWD), at the Baylor College of Medicine in Texas, conducts research on a wide range of topics in the area of women with disabilities. The NCMRR has provided support for the Center in the past. The CROWD Web site offers patient information on reproductive health for women with disabilities. The site also offers results from the National Study of Women with Physical Disabilities, a study supported by the NCMRR that spurred the creation of CROWD. |