Newswise — The Food and Drug Administration should require clear labeling on all prescription drug and biological products to educate pregnant and lactating women about potential health risks for women and their fetuses or nursing infants, the Society for Women's Health Research told the agency Thursday in a public comment letter in response to the FDA's request for input on plans to change medication labeling.
The Society, a national non-profit organization based in Washington, D.C., believes the proposed regulatory amendments have long been needed to improve health care for pregnant or nursing women and their children. Women and their health care providers often do not have adequate information to assess the health risks of a treatment to fetuses or nursing infants.
"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 and health care outcomes," President and CEO Phyllis Greenberger and Vice President of Public Policy Martha Nolan said on behalf of the Society.
Specifically, the Society believes that fetal risk summaries should be listed first in the pregnancy subheading of drug labels. The risk information should include short and long term side effects and reflect the severity of the condition for which the treatment may be prescribed. This is vital information for women who are or may become pregnant and must weigh treatment options for chronic health conditions.
The Society also believes that pregnancy exposure registries, which monitor the outcomes of pregnancies exposed to specific medical products, should be enhanced to inform future research and treatment decisions. More research is also needed to examine the levels and effects of drugs in breast milk.
"Beyond labeling of current know risks, we need more research to understand how medical treatments affect pregnant women and their children," Greenberger said. "These groups have not been adequately studied in the past, so we can't conclude that research on medication use in the general population will apply to them. This is an important point that holds true for all medical research.
"We know there are substantial differences between women and men and among different racial and ethnic groups in health and disease, including responses to treatments. Research studies must be designed and analyzed with a focus on group differences. If scientists don't ask questions about how women, children, minorities or the elderly might be affected differently and publish the results, our understanding of population differences will never grow and we'll struggle to close gaps in health outcomes for these groups."
The FDA will consider the comments in preparing a report to Congress on the issue.
On the Net:Society for Women's Health Research: http://www.womenshealthresearch.org/
FDA Call for Comments Related to the Requirements for Pregnancy and Lactation Labeling proposed regulation (Docket no. FDA-2006-N-0515): http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064806051dd
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