Children With Inflammatory Bowel Diseases are Disadvantaged by Current Drug Approval Policies: A Call for Urgent Change.

Treatment of pediatric inflammatory bowel disease (IBD) is significantly hindered by the lack of US Food and Drug Administration-approved biologic and small-molecule medications. This review explains the burdens faced by children with IBD because of this problem and appraises the marked historical timeline differences in medication approval between adults and children with IBD. The authors follow with an in-depth focus on the pointed disparity in approved therapies for children with IBD compared to children with rheumatologic immune-mediated diseases, highlighting the differences in stringency of evidence that has been used to gain medication approval for children with rheumatologic diseases. The editorial concludes with a call for change in regulatory agency protocols, to adopt a modernized strategy that will expedite the approval of advanced therapies for children with IBD.