FDA announces public meeting on pediatric exclusivity and drug development

On May 15, 2025, FDA will hold an all-day public meeting to obtain input from interested parties for the agency’s report to Congress on pediatric drug development and labeling. Section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to submit a report to Congress every 5 years on the implementation of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) and to obtain recommendations or relevant information from interested parties for the report.

As we discussed in a previous alert, under the BPCA, drug and biologics sponsors are awarded a six-month period of pediatric exclusivity that extends other patents and regulatory exclusivities in exchange for conducting pediatric studies.  PREA generally requires sponsors of new active ingredients, indications, dosage forms, dosing regimens, or routes of administration to conduct pediatric assessments, unless such assessments are waived or deferred by FDA. Together, the BPCA and PREA provide incentives and requirements to spur study in pediatric patients so that drugs and biologics can be labeled with useful information for children. 

Topics to be discussed at the public meeting include:

• the public health impact that the pediatric legislation has had on interested parties, including treatment advances for children, as well as areas of continued unmet medical need;
• the effects of the requirement for pediatric studies under PREA or the incentives under BPCA on drug/biologic development plans, including issues related to international alignment on pediatric drug development;
• any barriers or resource issues preventing undertaking or completing studies under PREA and BPCA; and 
• successes and challenges with leveraging scientific advances in product development, such as pediatric extrapolation and real-world data.

Interested parties attending the meeting, whether virtual or in-person, may request to make an oral comment at the meeting, and comments may also be submitted to the docket online before and after the meeting through June 13, 2025. 

If you may want to submit a comment, or have questions on pediatric drug development more generally, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Dave Fox, Komal Karnik Nigam, and Deborah Cho.