SWHR Supports New Requirements for Pregnancy Drug Labeling

SWHR supports Sen. Kohl and FDA on important women’s health legislation

Washington, DC (January 28, 2011) – On Wednesday, Sen. Herb Kohl of Wisconsin furthered a Society for Women’s Health Research (SWHR) long-term advocacy priority with his letter to support new drug labeling and protections for pregnant women. Sen. Kohl and SWHR submitted independent letters with proposed guidelines to the Food and Drug Administration (FDA) regarding the delay in issuing new guidance and labeling for medication use to protect pregnant women.

The requirements outlined in the proposed regulation will give pregnant and nursing women and their clinicians important and detailed information that will improve treatment decisions as well as health outcomes. The case for more comprehensive information on prescription use during pregnancy is clear, and reflects the larger issue of decades of under-studying and under-reporting in women’s health. SWHR has long fought for clinical trials to look at sex differences, as well as racial and ethnic differences in how people react to drugs and biologics.

“SWHR is pleased to support potential revisions to drug labeling in order to protect one of the most vulnerable populations, pregnant women,” said Phyllis Greenberger, M.S.W., President and CEO of SWHR. “Pregnant women and their fetuses need protection from possible harms, but this is only possible when we know how to inform care choices. Without appropriate research and labeling, women are being denied the chance to make informed decisions.”

Nine out of ten medications on the market today have an undetermined risk for use in pregnancy and lactation. An estimated 50% of pregnancies in the U.S. are unplanned, often precluding a woman from stopping or changing potentially hazardous therapies before conceiving. A vast majority of women will use prescription or over-the-counter medications while pregnant.

As the current system for drug risk classification was developed in 1975, SWHR and others believe that the proposed labeling rules, under consideration since 2008 by the FDA, are long overdue. Better information and labeling will substantially advance and augment the health care treatment and procedures for pregnant and nursing women and their children. This large portion of the general population needs added protections and cautions on drugs and biological products, but for too long women and their providers have been forced to make decisions based on limited and inadequate research. SWHR is excited to see and motivate further momentum towards getting this labeling rule passed through FDA.

Click Here to Read SWHR's Comment Letter regarding Pregnancy Drug Labeling.


For more information on the Society for Women’s Health Research please contact Rachel Griffith at 202-496-5001 or Rachel@swhr.org.

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