261073 Informed use of medicines in children and pregnant women: Overcoming the challenges

Tuesday, October 30, 2012 : 8:30 AM - 8:50 AM

Rosemary Addy, MHS , Center for Drug Evaluation and Research, Pediatric and Maternal Health Staff, U.S. Food and Drug Administration, Silver Spring, MD
Carrie Ceresa, Pharm D, MPH , Center for Drug Evaluation and Research, Pediatric and Maternal Health Staff, U.S. Food and Drug Administration, Silver Spring, MD
Lynne Yao, MD , Pediatric and Maternal Health Staff, Food and Drug Administration, Silver Spring, MD
Susan McCune, MD , CDER/Office of Translational Sciences, FDA, Silver Spring, MD
     
Historically, data to support the use of medications in children and pregnant women has been limited and impacted health across the lifespan with potentially devastating consequences for public health. Addressing this data gap is critical and in order to address this gap in knowledge and enable health care providers to make well-informed decisions, FDA has collaborated with stakeholders in recent years to develop clinically relevant, evidence-based communications to facilitate the informed use of medicines in children and pregnant women. Great strides have been made studying medication in children. Some of the lessons from this work may be applied to fill the data gap with regard to medication use during pregnancy. For example, one advance is the now routine integration of pediatric populations into the planning process for the development of new drugs instead of waiting to address pediatric needs until well after a new drug has been approved. This session will explore the advances in pediatric medicine, inform the audience about current regulations and rules that govern drug development for pediatric patients as well as pregnant and nursing mothers, evaluate the successes and also discuss the challenges of including pregnant women in clinical trials.

Learning Areas:
Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
1. Identify current laws and regulations that govern pediatric and maternal medicine. 2. Evaluate the success of including children in clinical trials. 3. Discuss the challenges and requirements for inclusion of pregnant women in clinical trials.

Keywords: FDA, Maternal and Child Health

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am an officer in the United States Public Health Service. I joined the Food and Drug Administration in 2008 and the Pediatric and Maternal Health Staff in 2010 where I serves in a dual role as a Regulatory Reviewer and Project Manager. I earned a Bachelor of Science in Biology from the University of Maryland, a Doctorate of Pharmacy from Shenandoah University and a Master of Public Health from the University of North Carolina.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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