Advocacy

A key advocacy issue and a cornerstone in the mission of The Pediatric IBD Foundation is the creation of a public safety registry for medicines used to treat children with IBD. Currently, it takes an average of 9 years for medications approved in adults to be approved in children. Medications are often needed but not approved for children with IBD and are prescribed “off label". Companies are not required to monitor safety of off-label prescriptions.

We continue to work diligently with federal agencies (FDA/NIH) and industry to create this public safety registry with meetings and conferences to maintain momentum while we define and refine solutions and strategies to make this vital resource a reality for our children.

The registry will be an indispensable resource and supported by public-private partnerships. Most importantly, the public safety registry will be accessible to industry, investigators and federal regulators thereby greatly enhancing drug development of treatments for children with IBD.

Simply put, the public safety registry will:

• help expedite approvals of pediatric medications and therapies for IBD

• reduce costs to drug companies for required safety monitoring thereby reducing costs to patients

• provide open access to FDA/NIH/EMA to identify signals of unexpected events

Through a public-private partnerships, the IBD public safety registry will operate as an independent 501c3 and modeled after a similar, very successful registry in pediatric rheumatology, (CARRA).

In addition, we will pursue a data-sharing agreement with the CARRA public registry as both Juvenile Arthritis and IBD are autoimmune diseases often treated with the same medications. We believe this will greatly aid our understanding of these diseases and the long-term effects of treatments that often involve suppressing a child’s developing immune system.

Please join us as we make living with IBD safer for all our children,

Eric Zuckerman, DO

Chair, Pediatric IBD Foundation