Optimizing the Use of Postapproval Pregnancy Safety Studies


FDA Convening

Optimizing the Use of Postapproval Pregnancy Safety Studies

Event Graphics Including Name Time and Date of Event


Optimizing the Use of Postapproval Pregnancy Safety Studies


September 18, 2023

10:00 AM - 4:30 PM ET

September 19, 2023

10:00 AM - 2:30 PM ET


In the United States (U.S.), approximately 5.5 million pregnancies occur each year.1  Half of the individuals who are pregnant use at least one drug or biological product to treat chronic (e.g., diabetes, seizure disorders, or asthma), acute (e.g., infection) or serious medical conditions.2  Typically at the time of initial market approval, there are limited to no human data on the safety of drug or biological products used during pregnancy.  As a result, for most products, human pregnancy safety data are collected after a product is available on the market (i.e., postapproval). 

In May 2019, FDA published a draft Guidance for Industry titled Postapproval Pregnancy Safety Studies,3 which discusses the strengths and limitations of postapproval study types including studies based on registry data and cohort studies using electronic health records or claims data. However, more research is needed to better understand the key considerations for determining the optimal postapproval study designs to obtain timely evidence to ensure the safe use of drug and biological products in pregnant individuals. The public workshop is a preliminary discussion with stakeholders to inform FDA’s further development of a framework and also meets a performance goal under the FDA User Fee Reauthorization Act of 2022, in accordance with the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027 letter (PDUFA VII Commitment Letter), which is available at https://www.fda.gov/​media/​151712/​download. Specifically, the PDUFA VII Commitment Letter outlines the commitment of a public workshop to discuss postapproval pregnancy safety studies to facilitate determination of ideal study designs.

The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. FDA, is convening a two-day Public Workshop that will discuss designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). During this event, participants will hear FDA’s considerations for constructing a framework describing how data from different types of postapproval pregnancy safety studies might optimally be used; stakeholders’ perspectives on opportunities to optimize postapproval pregnancy safety study types and designs; design considerations and potential approaches to bridge knowledge gaps in developing the framework, including understanding how the Sentinel Initiative (i.e., Sentinel System and Biologics Effectiveness and Safety (BEST)) may address these gaps; and stakeholders’ perspectives on considerations for FDA’s proposed framework. 

[1] U.S. Centers for Disease Control and Prevention, National Center for Health Statistics. U.S. Pregnancy Rates Drop During Last Decade [Press Release] Hyattsville (MD); 2023 April 12, Available from: https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2023/20230412.htm.

[2] Mitchell AA, Gilboa SM, Werler MM, et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011;205:51.e1-8.

[3] U.S. Food and Drug Administration. Postapproval Pregnancy Safety Studies Guidance for Industry. Silver Spring, (MD); 2019 May, Available from: https://www.fda.gov/media/124746/download.


If you plan to attend this event in-person and require special accommodations due to a disability, please contact Luke Durocher no later than 5 p.m. Eastern Time, September 4th, 2023.


Acknowledgement of Funding

This meeting is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $5,192,495 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Duke-Margolis Planning Team

Nancy Allen Lapointe

Nancy Allen LaPointe

Faculty Fellow, Duke-Margolis Institute for Health Policy
Margolis Core Faculty
Adjunct Associate Professor in the Department of Medicine Faculty

Maryam Nafie Headshot

Maryam Nafie

Policy Analyst