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Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy

Photo of female health care specialist talking with pregnant woman in exam room.

By: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) and Amy Ramanadham, PharmD, MS, Staff Director of Drug Safety Operations, CDER 

Every year, there are approximately 5.5 million pregnancies in the U.S. Many pregnant individuals have chronic conditions, such as diabetes or asthma, that require continual treatment. Some patients may develop medical conditions during pregnancy that necessitate therapy; others take medications before they realize they are pregnant. This amounts to approximately 50% of pregnant people using at least one prescription medication at some point during their pregnancy. 

Patrizia Cavazzoni M.D.
Patrizia Cavazzoni, MD

With this high percentage, it is important to generate appropriate and timely information regarding the safe use of medicines during pregnancy, and the U.S. Food and Drug Administration continues to work with several partners to optimize studies and methods to obtain this data for available medicines. Pregnant individuals are often excluded from clinical trials of investigational medicines for a variety of reasons. As a result, when medicines are approved and first enter the market, there are often limited or no human data about their safety in pregnancy. 

Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling. To achieve this, the medical community needs to improve the quality of pregnancy safety studies so that they yield as much relevant information as possible. In 2014, the FDA held a public meeting on postapproval pregnancy study approaches. In 2019, the agency published a draft guidance on this topic. 

Upcoming Public Workshop to Discuss Pregnancy Safety Studies

The FDA is continuing our efforts to enhance postapproval pregnancy safety studies, capitalizing on the increased availability of population-based health care data and advances in methods to study the benefits and risks of treatments. One of the FDA’s Prescription Drug User Fee Reauthorization Act VII commitments is to develop a framework that describes how to optimally use data from postapproval pregnancy studies to identify and evaluate safety signals that provide useful and timely information in product labeling for prescribers and patients. As one part of this commitment, the Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, is holding a two-day public workshop on Sep. 18-19 to discuss pregnancy safety studies. 

Amy Ramanadham, PharmD, MS
Amy Ramanadham, PharmD, MS

At the workshop, attendees will assess the current processes to collect and evaluate postapproval pregnancy safety information and consider ways to advance this field of research to generate timely pregnancy safety data. Sessions will explore the different study types and designs, such as registries (systems that systematically collect health care information about people with a specific disease or condition or who are being treated with a particular drug or biological product) or through medical claims analysis. There will also be opportunities to discuss how to fill in knowledge gaps by using electronic data sources, such as the FDA’s Sentinel Initiative, which evaluates the safety of medical products and has developed tools that specifically look at pregnancy safety, and the agency’s Biologics Effectiveness and Safety (BEST) System, which evaluates the safety and effectiveness of biologics. 

A large portion of the meeting later this month will be devoted to beginning our work on the pregnancy safety study framework. FDA presenters will participate in discussions with stakeholders to help inform the development of the framework. In 2024, the FDA plans to publish a workshop report and begin five demonstration projects, which are relatively small-scale projects to illustrate a particular approach. These projects will address gaps in our knowledge about different study designs. By 2027, we will update the framework based on the results of these demonstration projects and publish an analysis of our findings.

Over several years, the FDA has been engaging in dialogue and information sharing among researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing post approval safety studies. The upcoming workshop is another opportunity to participate in and propel this ongoing discussion.


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