Working to Improve Information on Medication Use during Pregnancy

When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages.  But what to do about prescription drugs is a more complicated topic.

There are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical practice must prescribe needed medicines to pregnant women to treat a variety of illnesses and conditions such as diabetes, high blood pressure or even something as simple as a dental infection.

Indeed, about half of the 6.3 million women who are pregnant every year take at least one medication, and prescription use is on the rise, up by more than 60 percent from 1976 through 2008.

More information is clearly needed. The 21st Century Cures Act, which was enacted in 2016, established a task force to consider what is being done to identify and address gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. Within 18 months after it is established, the task force will develop a report to Congress with specific recommendations for addressing the issues identified. The Office of Women’s Health (OWH) is leading FDA’s activities for the task force. My colleagues at OWH will be working with FDA’s Centers to promote dialogue and research collaboration. We look forward to hearing from our public and private partners at the Task Force’s two-day public meeting, which begins today.

Meanwhile, we are continuing our work to help ensure that doctors and their patients have better drug information. In 2015 we began implementation of new requirements for the pregnancy and lactation subsections of labeling for prescription products. The new requirements provide a framework for clearly communicating information on the benefits and risks of using a drug during pregnancy and lactation and also remove the decades-old pregnancy category letter system that was often confusing and did not accurately or consistently communicate differences in degrees of fetal risk.

FDA is also collaborating on research to fill in the gaps of our knowledge about medication use by pregnant women. OWH leads pregnancy research initiatives that fund studies and workshops to support FDA decision-making. Some of our research is using predictive modeling to try to anticipate how pregnant women might respond to a drug without having to expose them to the drug during a clinical trial. Other projects address emerging issues like Zika while others have examined ongoing issues like food safety in pregnancy. FDA’s Centers are also conducting research to better understand the safety, efficacy and effects of products used during pregnancy. Their research addresses a wide array of topics including vaccine safety, MRI effects, drug toxicity, and tobacco use and its potential impact in pregnancy.

Through the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), a multi-site research collaboration between FDA, academia and health insurers, FDA is doing research to learn more about medication effects by linking healthcare records for moms and babies. MEPREP has already conducted a number of projects including an award-winning study of sulfonamide use during pregnancy and the risk of congenital anomalies. MEPREP is currently conducting a 3-year epidemiologic study to evaluate a potential association between neural tube defects and maternal exposure to prescription opioids.

Finally, we are doing what we can to encourage pregnant women to enroll in a pregnancy exposure registry if they take a prescription drug for a medical condition. Enrolling can help improve safety information for medicines used during pregnancy and can be used to update drug labeling. FDA’s pregnancy registry site connects women and health professionals to over 40 registries and provides links to drug information and educational resources on medication use during pregnancy. Studies conducted with the registry data can help to provide information on the effects of prescription drug and vaccine exposures on the health of pregnant women and, after they give birth, of their babies.

Real-World Research and Safety Monitoring

FDA’s pregnancy research assists in the assessment and safety monitoring of the range of products that pregnant women use in their daily lives. Our guidance and policy efforts provide a research framework for industry. And, our pregnancy outreach activities help to raise awareness and disseminate timely safety information. The work that we do with other government and private sector partners leverages existing data and collaborative approaches to address gaps in knowledge about medication use during pregnancy.

Throughout my career at FDA, I have had the chance to collaborate with diverse partners on pregnancy research with MEPREP and later in my role at OWH, and I have seen the positive impact of FDA’s pregnancy initiatives. I look forward to the task force report. But in the interim, I know that OWH will continue to serve as an information source and catalyst for research in support of FDA’s ongoing commitment to providing pregnant women and their healthcare providers with the best possible information to guide their healthcare decisions.

By: Pamela E. Scott, Ph.D.

Pamela E. Scott, Ph.D., is Deputy Director and Director of Research and Development, FDA Office of Women’s Health