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

Benjamin Sahn1,2, Ross M Maltz3,4, Joel R Rosh1,2

  • 1Northwell, New Hyde Park, NY, USA.

Crohn'S & Colitis 360
|July 1, 2025
PubMed

Insights

Pediatric inflammatory bowel disease (IBD) treatment is limited by a lack of FDA-approved medications. This review highlights approval delays and calls for regulatory changes to expedite pediatric IBD therapies.

Area of Science:

  • Pediatric gastroenterology
  • Clinical pharmacology
  • Regulatory science

Background:

  • Pediatric inflammatory bowel disease (IBD) treatment faces significant challenges due to a scarcity of US Food and Drug Administration (FDA)-approved biologic and small-molecule medications.
  • Children with IBD experience substantial burdens stemming from these treatment limitations.

Purpose of the Study:

  • To explain the burdens of limited FDA-approved medications for pediatric IBD.
  • To appraise historical differences in medication approval timelines for adult versus pediatric IBD.
  • To compare the disparity in approved therapies for pediatric IBD versus pediatric rheumatologic immune-mediated diseases.

Main Methods:

  • Review of historical medication approval data for IBD and rheumatologic immune-mediated diseases in pediatric populations.
  • Analysis of regulatory agency protocols and evidence stringency for medication approval.
  • Comparative assessment of therapeutic options available for pediatric IBD versus other immune-mediated conditions.

Main Results:

  • Significant historical delays exist in FDA approval of medications for pediatric IBD compared to adults.
  • There is a notable disparity in approved advanced therapies for pediatric IBD when compared to pediatric rheumatologic diseases.
  • Evidence requirements for approving medications for pediatric rheumatologic diseases appear less stringent than for pediatric IBD.

Conclusions:

  • Current regulatory protocols hinder timely access to advanced therapies for children with IBD.
  • A modernized regulatory strategy is needed to expedite the approval of essential medications for pediatric IBD.
  • Changes in regulatory agency protocols are crucial to improve treatment outcomes for pediatric IBD patients.

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