FDA Updates System for Explaining Risks of Meds in Pregnancy

By Emily Largent

On Wednesday, the FDA published the “Pregnancy and Lactation Labeling Rule” (PLLR), which “requires changes to the content and format for information presented in prescription drug labeling . . . to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children.”  The FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling and format requirements.

The current system, which was developed in the 1970s, uses letters of the alphabet–A, B, C, D, and X–to denote risk, with X being the most dangerous.  The PLLR removes pregnancy letter categories from all prescription drug and biological product labeling.  The new system breaks the risk into three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential.  Companies will be required to provide a summary of risks, a discussion of the data supporting that summary, and relevant information to help clinicians make prescribing decisions.  The changes go into effect on June 30, 2015.  Labeling for over-the-counter medications will not change.

The PLLR should help many women, as there are more than 6 million pregnancies in the U.S. each year.  Research suggests that over 90% of women use at least one medicine during pregnancy, and about 70% use at least one prescription medicine.  I think the PLLR is a wonderful step to enhance patient education and decision-making.  It will not, however, address our limited current knowledge of the safety of medication use during pregnancy.  About 98% of medicines approved for use in the United States between 2000 and 2010 had limited data to assess the risk for birth defects, for example.  More research is urgently needed, and it’s unfortunate that the rule stops short of requiring companies to conduct studies if none exist.

Emily Largent

Emily Largent

Emily Largent is an Assistant Professor of Medical Ethics and Health Policy at the Perelman School of Medicine. She also teaches at the University of Pennsylvania LawSchool. Her research examines ethical and regulatory issues arising in human subjects research and when integration of clinical research is integrated with clinical care; she has a particular focus on Alzheimer’s disease research. Emily received her PhD in Health Policy (Ethics) from Harvard and her JD from Harvard Law School. Prior to that, she received her BS in Nursing from the University of Pennsylvania School of Nursing and completed a fellowship in the Department of Bioethics at the National Institutes of Health.

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