Statement of Dr. Jennifer L. Howse, President, March of Dimes on the final FDA rule on pregnancy and lactation labeling for prescription drugs and biologics

Washington, District of Columbia | Wednesday, December 3, 2014

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Cindy Pellegrini

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The March of Dimes released today the following statement from President Dr. Jennifer L. Howse regarding the Food and Drug Administration’s (FDA) release of its final rule on pregnancy and lactation drug labeling information for prescription drugs and biologics:

“The March of Dimes hails the release of the final rule, which will drive critical improvement to prescription drug labels regarding known effects on pregnancy, breastfeeding, and fertility.  The rule takes vital steps to improve the organization, readability, and usefulness of this information, which will enable women and their providers to find it use it more readily. 

“The final rule eliminates the pregnancy categories of A, B, C, D and X, which were not consumer-friendly or easy to understand.  Categories titled “Pregnancy,” and “Lactation” will contain all the relevant information about the drug’s known or expected impacts on all aspects of pregnancy, labor and delivery, and breastfeeding for both mother and child.  In addition, information important to women of child-bearing age in making various decisions about their reproductive health and future would be consolidated in a new category, “Females and Males of Reproductive Potential.”  In this way, both patients and providers are more likely to be able to locate the information they need and use it to make informed health decisions.

“It is important to note, however, that this rule is only a first step, and it does not address other crucial issues related to pregnancy, lactation, and prescription drugs.  In many cases, the effects of prescription drugs and biologics on pregnancy, lactation and other aspects of reproductive health are simply unknown.  For many drugs, the new labels will have little or no useful information to provide to women and health care professionals.  Promoting enrollment in pregnancy registries is a useful step, but not the full answer to this challenge.  The March of Dimes looks forward to working with the FDA and other interested stakeholders to ensure that appropriate research is performed and data generated to allow women and their health providers to make fully informed decisions about medication and its expected impact on pregnancy, lactation and childbearing.”

About March of Dimes

March of Dimes leads the fight for the health of all moms and babies. We support research, lead programs and provide education and advocacy so that every baby can have the best possible start. Building on a successful 80-year legacy of impact and innovation, we empower every mom and every family.

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