• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Regulatory Information

  • Print
  • Share
  • E-mail

Fact Sheet: Pediatric provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA)

FDASIA renews and strengthens three essential laws to improve the safety and effectiveness of pediatric drugs, biological products, and medical devices used in children: the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Pediatric Medical Device Safety and Improvement Act.

Key Facts

Children have unique needs for medical products and these provisions increase the FDA’s ability to meet these needs.

By making BPCA and PREA permanent – no longer subject to reauthorization every five years – the law ensures that children will have a permanent place on the agenda for drug research and development.

FDASIA requires earlier pediatric study plan submission by drug manufacturers subject to PREA and gives FDA new authority to help ensure PREA requirements are addressed in a more timely fashion.  These improvements will help spur pediatric drug development and speed pediatric drug information to patients and providers.

To address continuing needs for neonatal expertise, the Act requires the Office of Pediatric Therapeutics to include a staff member with expertise in a pediatric subpopulation that is less likely to be studied under BPCA or PREA and specifies that for five years after enactment, this should include an expertise in neonatology.  It further specifies that an FDA employee with expertise in neonatology should sit on the Pediatric Review Committee.  FDASIA also requires BPCA requests for pediatric drug studies to include a rationale for not including neonatal studies if none are requested.

For pediatric studies submitted under BPCA 2002 for products granted pediatric exclusivity and receiving a pediatric labeling change, FDASIA requires FDA to post the medical, statistical, and clinical pharmacology reviews and corresponding written requests on the FDA website in the same manner as currently posted materials. (Previously, only medical and clinical pharmacology summaries were required to be posted for these products.)  
 
FDASIA also requires FDA hold a public meeting and to issue a report on efforts to accelerate development of products for pediatric rare diseases.