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The St. Baldrick’s Foundation commended the U.S. Food and Drug Administration (FDA) for convening a three-day hearing on issues related to drug development for rare diseases including certain types of childhood cancer, in written comments submitted to the agency in March.
The Foundation urged the FDA to strengthen the Pediatric Research Equity Act (PREA), which requires pharmaceutical companies to study adult drugs for use in children only if the drug is developed for a disease that occurs in both children and adults.
Because common adult cancers, including breast, colon, lung, and prostate cancers, typically do not affect children, companies receive waivers so they are not required to study these drugs in children, even though they may hold great promise.
“The St. Baldrick’s Foundation urges the FDA to seek every opportunity to strengthen PREA in hopes that promising cancer drugs for adults can more readily turn into promising cancer drugs for children as well,” stated Kathleen Ruddy, St. Baldrick’s Foundation Chief Executive Officer, in the comments.
The St. Baldrick’s Foundation also urged the FDA to refrain from referring to all childhood cancers as “rare,” to work with industry to create programs and incentives to encourage the development of new drugs for children with cancer, and to consider parents and other adult caregivers as the most appropriate persons to report treatment outcomes for young patients enrolled on drug development protocols.
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