Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -35

Accepted - Volume 1

Comment Record
Commentor Dr. Carmelita Britton Date/Time 2002-07-01 14:22:25
Organization Albany Medical College
Category Health Professional

Comments for FDA General
Questions
1. What changes to the pediatric rule, if any, would be necessary to integrate the BPCA and the pediatric rule more effectively? Noting that the BPCA is subject to continuation by Congress and that future reauthorization is uncertain, the Pediatric Rule should mirror the scope of the BPCA and apply to all labeled and potential indications as well as new indications. If a company submits a supplemental indication to the FDA, it invokes the Pediatric Rule. It is imortant that appropriate pediatric studies be conducted for that new use; and if the current label lacks appropriate pediatric use information (e.g., for neonates) the FDA should also include in their requirement for pediatric studies of the new indication, any pediatric studies that may be needed for the currently labeled or potential indications.
3. What provisions, if any, of the BPCA could apply to biological products regulated under section 351 of the PHSA? It is essential that the Pediatric Rule remain in place because it is the only mechanism that ensures that biological products will be studied and available for children. No provision of BPCA applies specifically to biological products since the legislation focuses on drugs covered by the Food, Drug and Cosmetic Act (FDCA) and the vast majority of biologics are covered under the Public Health Service Act. Moreover, some of the most innovative new therapies now and in the future are biological products, which are not covered under BPCA.
5. General Comments As a pediatrician who cares for infants and children every day, I welcome the opportunity to comment on the relationship between the 1998 Pediatric Rule and the Best Pharmaceuticals for Children Act (P.L. 107-109). In March 2002 the FDA proposed to suspend the Pediatric Rule. While this proposal was reversed, this action indicates that children are at risk of losing the ground we have fought so hard to secure for them. The Pediatric Rule ensures that children are no longer a therapeutic afterthought by the pharmaceutical industry, and that children have the quality and quantity of drugs they need. This Rule makes medications for children a certainty, not an option, and puts children on a level playing field with adults for the first time. I believe that all components of the 1998 Pediatric Rule must be preserved.  Retiring or relaxing any authorities currently in the Pediatric Rule is inappropriate and would be to the detriment of children. It must always be kept in mind that BPCA is time-limited, voluntary and subject to continuation by the Congress. Those facts speak directly to the need to ensure that the Pediatric Rule remains in place in its entirety.  In determining the process of when pediatric studies are conducted, the FDA should rely on the detailed process for requesting pediatric studies of already marketed drugs and securing labeling that is outlined in the BPCA.  Appropriate formulations are an essential component of providing medications for the pediatric population. It is a requisite for studies in infants and younger children to develop age appropriate formulations, if necessary. Failure to require needed formulations for specific age populations negates the intent of the BPCA and the Pediatric Rule.  BPCA limits its reference to recommendation for formulation changes only to studies completed under public contract. This provision was included to acknowledge that once a formulation is developed in the study phase, while it may be necessary to manufacture that formulation, it may not always be possible to scale up the formulation for distribution to the general public. Thank you for your consideration of these comments.




EC -35