We are now over a month into a new regime in the U.S. that paves the way for pregnant women to be better provided for. As of June 30, the Food and Drug Administration (FDA) revised the rules on the labeling of prescription drugs, meaning that doctors have more information and women can expect better advice.
“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal, and infant risk-benefit considerations,” says Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.”
What the changes mean
The drug labels will include three subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. While consumers won't see new labels on pill bottles or bags, doctors will have more information to discuss with them.
So how will this change things at real life level? The American College of Obstetricians and Gynecologists (ACOG) has welcomed the move as an important step towards making sure pregnant women get the care they need.
“As obstetrician-gynecologists, we understand the importance of keeping women healthy before, during, and after their pregnancies, whether they live with chronic conditions or whether they are confronting new diagnoses,” ACOG said in a statement. “And, we recognize that medications can be vital to maintaining a mother's continued good health when pregnant, a goal of central concern in obstetric care.”
However, there may be another important effect: the new rules could stimulate research.
At the Pregnancy and Medicine Initiative, we’ve talked before about the urgent need for pregnant women to be included in studies about medication. Their exclusion is what lies behind the dangerous data gap around pregnancy and medication. Now, ACOG is hopeful that things could be changing.
“By updating the labeling, the FDA is helping to encourage manufacturers to conduct needed research on the impact of medicines during pregnancy and lactation,” Dr. Barbara Levy, vice president of policy at ACOG told us.
“ACOG hopes that the inclusion of more information on prescription medicine labeling will provide added incentives for clinical research as well as participation in patient registries, to better capture the impact that prescription medicines have on pregnant and breastfeeding women.”
On clinical trials
ACOG already has a clear stance and supports the idea that all women should be presumed eligible for participation in clinical studies. “The potential for pregnancy should not automatically exclude a woman from participating in a clinical study,” says the organization. “Consent of the pregnant woman alone is sufficient for most research. Pregnant women considering participation in a research study should determine the extent to which the father is to be involved in the process of informed consent and the decision.”
Provided informed consent is given, and subject to the usual risk-benefit analysis, the inclusion of women in research is not only vital but also moral, the organization believes.
“Systematic exclusion of women from research violates the ethical principle of justice, which first requires that persons be given what is due them,” ACOG says. “If the medical treatment of women is invalidly based on studies that excluded women, then they are not receiving fair treatment.”
With this is mind, perhaps the added incentive to manufacturers (clinical research) that the new FDA ruling provides could be its most important outcome.