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Senate Briefing – Turning the Tables: Innovator Meets Regulator

Senate Briefing – Turning the Tables: Innovator Meets Regulator

At a Senate briefing hosted by Friends of Cancer Research (Friends), a panel comprised of leading stakeholders convened to discuss changes in cancer care and criticisms of the U.S. Food and Drug Administration’s (FDA) expedited approval programs. As recent advancements to discover and develop targeted therapies, immunomodulating agents, and cell-based therapies provide new and potentially transformative opportunities for patients, the FDA’s current expedited approval programs facilitate faster approvals for patients in greatest need. While the FDA continues to adapt regulatory pathways to changes in treatment paradigms, the panel addressed critics concerns with the agency’s approach head on. For highlights from the briefing, watch the video below.



Throughout the hour-long conversation, the panelists discussed the importance of FDA’s expedited approval pathways paired with the considerable changes to cutting edge science and new, innovative treatments for patients. Within the last 20 years, drug-makers have shifted to producing higher caliber and targeted treatments with less toxicity for patients. As such, the FDA has evolved to provide the flexibility needed to review and approve these revolutionary drugs while ensuring the gold standard for safety and efficacy at the agency.


“For those promoting going back to the old models: how many patients are acceptable to die? Because they will die without innovation. ” – Ellen Sigal, Chairperson & Founder, Friends of Cancer Research


Panelists also warned against returning to previous eras of FDA regulation, where patients’ options were vastly limited, and the FDA rarely sought input or collaboration with patient communities and other stakeholders. Panelists noted that today drug developers, doctors, patients, and their advocates appreciate the FDA and how it regulates new treatments because the agency ensures an equal playing field, creates opportunities for patient input and collaboration throughout the regulatory process, and maintains high standards for safety and efficacy. It was also stressed that the expedited programs do not allow for special treatment; it allows for more open communication between the FDA and drug developer and leads to a more rigorous review of the data.


“We are privileged to live in a country and have a U.S. FDA that uses all its regulatory tools to adapt and be flexible in the face of compelling science.” – Josh Bilenker, CEO, Loxo Oncology at Lilly


The panel included: Dr. Josh Bilenker – CEO, Loxo Oncology at Lilly; Dr. Christine Lovly – Co-Leader, Translational Research & Interventional Oncology Research Program, Vanderbilt-Ingram Cancer Center; Dr. Richard Pazdur – Director of the Oncology Center of Excellence, U.S. Food and Drug Administration; Dr. Ellen Sigal – Chair & Founder, Friends of Cancer Research; and was moderated by Kate Rawson – Senior Editor, Prevision Policy.


FDA Research Video