Call For More FDA Resources Included in New House Appropriations Bill
Steve Wosahla is the Chief Executive Officer of Children’s Cancer Cause
Children’s Cancer Cause has long sought improvements in the development process to help children with cancer. This year, we embarked on a new advocacy effort to improve the drug development process. Our organization worked with key members of Congress to develop appropriations report language that has been included in the House Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies appropriations bill for fiscal year 2022.
We were pleased to see that it includes language that Children’s Cancer Cause submitted to key legislators regarding children’s cancer drug development. The report recommends increased resources for FDA and more extensive international collaboration around pediatric drug development. The specific language is below. The relevant House Subcommittee and the full Appropriations Committee passed the bill in late June. It now awaits consideration by the full House.
“The Committee encourages FDA to hire additional staff to fully implement the Research to Accelerate Cures and Equity for Children (RACE) Act,” the report states. Children’s Cancer Cause, working with the childhood cancer community, helped lead the charge to pass the Research to Accelerate Cures and Equity (RACE) Act.
The RACE Act went into effect in August 2020. Under the RACE Act, new molecularly targeted compounds for adult cancers need to be evaluated for children’s cancers. The enactment of this law requires a systemic response to realize the promise of new more targeted cancer agents.
The enactment of the RACE Act is also increasing the regulatory burdens on FDA. A growing number of sponsors are requesting Early Advice Meetings about drugs in their adult oncology pipeline to respond to the requirements of the RACE Act. Children’s Cancer Cause has long advocated that significant resources be made available to the FDA to hire additional staff to handle the influx of inquiries from sponsors and to fully implement the RACE Act.
Additionally, the report notes: “The Committee encourages the FDA to engage more formally and extensively with international entities to promote greater collaboration between the U.S. and international partners around pediatric cancer drug development.”
Children’s Cancer Cause believes an increase in the number of Pediatric Cluster Calls for oncology products is necessary to support FDA as it responds to sponsors’ requests for early advice meetings. The European Medicines Agency (EMA) and FDA have established monthly teleconferences (“Pediatric Cluster Calls”) to achieve greater efficiency and to avoid exposing children to potentially ineffective trials. Children’s Cancer Cause strongly supports FDA in its collaboration with EMA to ensure that the conduct of pediatric oncology clinical trials are internationally coordinated, carefully designed, and ethical.
The report language also supports efforts to facilitate follow-up coordination outlined in the recent FDA-EMA (European Medicines Agency) template. A new Common Commentary template introduced earlier this year provides a framework for companies seeking scientific advice from both the EMA and the FDA on new Pediatric Investigation Plans (PIPs) and initial Pediatric Study Plans (iPSPs), respectively.
We applaud the Committee for recognizing these important issues. We look forward to working with the Committee on other appropriations bills that will address related childhood cancer funding issues.
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