New FDA Drug Label Rule Makes it Easier for Pregnant, Breastfeeding Women to Understand Risks


The Food and Drug Administration (FDA) published on Dec. 3 a final rule on labeling biological products and prescription medication for the benefit of pregnant and breastfeeding women.

Providing consistency when including relevant information about the risks as well as benefits associated with biological products and prescription medication, the final rule replaces current product categories used for classifying risks with three subsections: pregnancy, lactation and females and males of reproductive potential.

The "Pregnancy" and "Lactation" subsections have further subheadings: risk summary, clinical considerations and data. Effective June 30, 2015, the rule also finalizes a lot of the provisions in the proposed ruling that the FDA issued in 2008.

According to Sandra Kweder, M.D., deputy director of the FDA Center for Drug Evaluation and Research's Office of New Drugs, prescriptions for pregnant and lactating women have to be individualized, involving complex risk-benefit considerations for the mother and fetus or child.

"The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk," she explained, adding the final rule offers explanations using available data about potential risks and benefits mothers and fetuses or breastfeeding children are exposed to.

The "Pregnancy" subsection will contain information on topics such as dosage and the potential risks of taking certain medication to the developing fetus, requiring information on the existence of a registry that collates and maintains data on the effects of biological products and medication on pregnant women. Information on pregnancy registries was recommended before but only with the release of the final rule was it required.

As for the "Lactation" subsection, it will feature information such as how much of a drug is passed through breastmilk and what the potential side effects are on a child when tainted breastmilk is consumed.

The "Females and Males of Reproductive Potential" subsection will offer information on contraception, pregnancy testing and infertility in relation to the use of biological products and medication.

Once the final rule is in effect, newly approved biological products and medications will be required to follow the prescribed format immediately. To help manufacturers adhere to the new rule, the FDA will also be issuing draft guidance for the industry detailing how the subsections are to be formatted in labels and what information should be included for each. Comments for the draft guidance may be sent online starting Dec. 4 through

More than 6 million pregnancies are reported in the U.S. each year. On average, women take between three and five prescriptions during the course of their pregnancy.

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