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Executive Director Jonathan Agin Provides Public Comment Before the Food and Drug Administration

On June 20, 2018, Executive Director Jonathan Agin provided open public comments before the Food and Drug Administration (FDA) Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on the issue of the implementation of the RACE for Children Act signed into law in August 2017.  The RACE Act fixes several loopholes in existing regulations in an effort to require drug companies to provide earlier access to new therapies for testing and initiation of clinical trials.  The FDA is required to hold periodic meetings to discuss the regulatory framework for implementing new laws so that all stakeholders understand what is expected.  As the RACE Act compels drug manufacturers to conduct pediatric investigations for adult drugs, if there is a similar molecular target, there are some open questions regarding these implications.

Jonathan implored the members of the subcommittee to interpret the legislation as broadly as possible.  As Jonathan explained, given the lack of drugs approved by the FDA over the past twenty years, the RACE Act provides an opportunity to accelerate new approvals and make an impact against forms of childhood cancer, like DIPG a terminal brain tumor that took his daughter.  Currently, there are over 900 drugs in the adult oncology pipeline with only a handful of drugs approved specifically for pediatric cancer.  Jonathan applauded the stakeholders including the FDA, clinicians, the National Cancer Institute and advocates for the passage of the RACE Act while at the same time urging for those gathered to create unambiguous regulatory guidelines aimed at bringing pediatric cancer drug development in line with so many new and promising scientific discoveries.  Ultimately, as Jonathan stated, requiring drug manufacturers to provide new drugs and compounds for pediatric testing can provide opportunities for industry to create new pathways for revenue generation.

Advocacy comprises the third prong of the Max Cure Foundation’s mission against childhood cancer.  Through Vice Chairman Richard Plotkin and Executive Director Jonathan Agin, Max Cure is at the forefront of the childhood cancer community effectively advocating for positive change in the fight against childhood cancer.  Stay tuned in the coming weeks, as we will highlight more of Max Cure’s recent advocacy efforts.