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# Bill Introduced to Spur Pediatric Rare Disease Studies
- URL: https://www.fdaweb.com/bill-introduced-to-spur-pediatric-rare-disease-studies/
- Published: 2024-08-06T12:00:00.000Z
- Updated: 2026-09-14T14:37:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157514

Senators **Jack Reed** (D-RI) and **Shelley Moore Capito** (R-WV) have introduced a bipartisan bill entitled “Innovation in Pediatric Drugs Act” (S 4905) that would attempt to accelerate research and treatment advances for pediatric rare diseases. The measure would make changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act to ensure drugs for rare diseases are studied in children and drug companies are accountable for completing pediatric study requirements, the lawmakers say in a [release](https://www.reed.senate.gov/news/releases/reed-capito-introduce-bipartisan-plan-to-accelerate-pediatric-rare-disease-research-and-treatment-advances?ref=fdaweb.com). “It would close research gaps created by the growth in so-called “orphan drug” approvals by … FDA,” they say, noting that most drugs for rare diseases (e.g., orphan drugs) are not required to be studied in children.

Reed and Capito also note that the Pediatric Research Equity Act-mandated due dates for required pediatric studies are typically deferred by FDA until after the approval of the drug for adults. “Unfortunately, FDA has no effective enforcement tools to ensure that these studies are completed on time — or at all,” they contend. Their Innovation in Pediatric Drugs Act would give FDA the authority it needs to ensure that legally required pediatric studies are completed in a timely manner.

A companion bill has been introduced in the U.S. House of Representatives by Reps. **Anna G. Eshoo** (D-CA) and **Michael McCaul** (R-TX).