FDA’s Recent Drug Labeling Changes Will Help Pregnant Women and Their Physicians
March 17, 2017
Overview
Prescribing drugs for patients is routine for physicians, but counseling pregnant patients about medication use is more complex. The FDA’s recent Pregnancy and Lactation Labeling Rule (PLLR) addresses this issue by making known drug safety data readily available to both doctors and patients.
Over six million pregnancies occur annually in the U.S., and many pregnant women suffer from acute and chronic conditions that necessitate medication use during or throughout pregnancy. The CDC estimates that 90 percent of women take at least one medication during their pregnancy. Of great public health concern is the lack of information available to determine whether a medication is safe to take during pregnancy. The FDA’s recent Pregnancy and Lactation Labeling Rule (PLLR) addresses this issue by making known drug safety data readily available to both doctors and patients.
In effect since June 30, 2015, the PLLR changes how prescription drugs are labeled with pregnancy-related safety information, replacing a labeling system that assigned drugs to discrete pregnancy risk categories (A, B, C, D, X) with one that emphasizes a narrative format and highlights human data. Under the PLLR, labeling must include a risk summary that incorporates a drug’s risks of use during pregnancy. When available, clinical considerations such as risks associated with untreated health conditions during pregnancy are provided to aid in prescribing and risk-benefit counseling. If a pharmaceutical company has established a scientifically acceptable pregnancy exposure registry to study outcomes of pregnancies exposed to a particular drug, the drug’s labeling must state that the registry exists and specify how to obtain information about it. When a pregnancy exposure registry generates new, clinically relevant data about a drug’s use during pregnancy, the pharmaceutical company must update the drug’s labeling to reflect this new information. With these highlighted changes, labeling affords more complete data, eliminating confusion and misperceptions associated with the previous letter categories.
With ready access to more comprehensive information, physicians and patients can engage in shared decision-making, which allows physicians to counsel pregnant patients on the risks and benefits of medication use based on best evidence. This process calls for a physician-patient relationship with effective communication and trust to ensure that patients comprehend detailed information and its relevance to their pregnancies. Thus, patients who have a regular physician they frequently communicate with may enjoy more successful shared decision-making than those who lack continuity of care. Doctors must also employ professional judgment and be well versed in labeling details, a more time-consuming task than under the previous system, where discrete letter categories provided quick cues. These efforts benefit patients, whose education and understanding of medication risks and benefits may alleviate anxiety about using medicines needed to maintain their own health during pregnancy. Finally, physicians can encourage their patients to participate in existing pregnancy exposure registries, which can help capture positive and negative outcomes of medication use in humans during pregnancy.
Overall, the PLLR facilitates shared decision-making by making what is known about prescription medications readily available to physicians and patients. Although relatively new, these changes may lead to improvements in maternal and child health by providing tools to promote healthier pregnancies and enhance fetal safety.
This blog post was developed by Erin Redmon, J.D., M.P.H., Fellow, Regulatory Science Program, University of Arizona, and Leila Barraza, J.D., M.P.H., Consultant, Network for Public Health Law – Western Region, Assistant Professor, Mel and Enid Zuckerman College of Public Health at the University of Arizona.
The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.
Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not necessarily represent the views of, and should not be attributed to, RWJF.