“Cancer patients cannot afford logistical delays and the OCE was not established to add another layer of bureaucracy.” – Ellen Sigal
Washington, DC – March 14, 2018 – On Thursday, March 15, 2018, the U.S. Food and Drug Administration (FDA) will hold a public listening session on the Oncology Center of Excellence (OCE) from 9am to noon. The meeting is for stakeholders to provide recommendations for the OCE, specifically in regard to: structure, function, regulatory purview, and activity.
Friends of Cancer Research’s (Friends’) Founder & Chair, Ellen Sigal, will present an oral presentation during the public meeting. Please find her full remarks below.
“Good morning. Thank you for the opportunity to be here and a part of this important discussion about a timely and unparalleled opportunity in the field of oncology.
Scientific advancements and increased funding for cancer research have led to transformative discoveries and better treatments for patients. The FDA plays a critical role in ushering these new therapies as quickly and safely as possible through the development and regulatory process. FDA has embraced this role and established itself as a global leader in approving new medicines. On behalf of all cancer patients, we thank you for your leadership.
But today’s discussion is about the future and ensuring FDA continues to be a global leader through the quick and effective implementation of the Oncology Center of Excellence. If the last few years are any indicator, the future will look nothing like the past.
The cancer treatment landscape is rapidly changing, and successful regimens now rely on multiple different types of products simultaneously. Cancer patients today may be given a drug, guided by the results of a diagnostic test, in combination with a complex biologic.
Each of these types of products is regulated by a different part of the FDA with different processes and timelines. Historically, for products used independently, this wasn’t a problem.
But for these combinations of technologies to be optimally developed and reviewed, the FDA of the future should look nothing like the past.
I recognize that the people here today are not the ultimate decision makers that determine the fate and structure of the Oncology Center of Excellence and the final decision ultimately rests with Commissioner Gottlieb.
Commissioner Gottlieb has stated the Oncology Center of Excellence would serve as a template for new centers of excellence to follow and would allow experts in different disease fields from across different centers at FDA to work together and speed product reviews. Commissioner Gottlieb stated that “it’s very important that we get it right.”
However, here we are 21 months after the Oncology Center of Excellence was announced as the first Inter-Center Institute established by 21st Century Cures, and we have no clear understanding of an organizational plan, processes, or timelines for achieving milestones for setting up the OCE.
Cancer patients cannot afford logistical delays and the OCE was not established to add another layer of bureaucracy. The OCE offers the opportunity for cross-center collaboration, coordination and prioritization guided by agency-wide leadership to remove redundancies and expedite reviews.
The external stakeholder community would benefit from understanding how the OCE will be organized, how it will be staffed, how it will function in relation to typical product reviews, and the timelines that will be met.
As Commissioner Gottlieb helps to implement a fully functional OCE, the cancer community has several requests:
- The FDA should work closely with the cancer community as it did in 2004 when the FDA successfully consolidated anti-cancer product review by transitioning the review of certain biologics, such as monoclonal antibodies, into the existing structure for cancer drug review in the Center for Drug Evaluation.
- The FDA should transition all OHOP staff and medical oncologists, support staff and project leads from CBER and CDRH to the OCE to add consistency and synchrony to the review of cancer treatments.
- The FDA should establish transparent processes and responsibilities for clinical reviews of oncology products including final sign-offs that span different centers with the goal of reducing bureaucracy and redundant reviews.
- The FDA should clarify the role of the OCE when it comes to requesting and review post-marketing clinical requirements, labeling requirements, and Risk Evaluation and Mitigation Strategies (REMS).
- The FDA should establish timelines and milestones for accomplishing implementation goals for the OCE to ensure it serves as a successful template for other centers of excellence.
- The OCE should leverage this expertise from across centers to develop and advance innovative regulatory science and promote patient-focused drug development of anti-cancer therapeutics
Cancer patients everywhere are counting on Commissioner Gottlieb to do the right thing by ensuring FDA remains a global leader in approving new therapies for cancer patients as quickly and safely as possible.”
For more information on Thursday’s meeting click HERE.
To watch the webcast, click HERE.
About Friends of Cancer Research
Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed lifesaving treatments to patients. For more information, please visit www.focr.org.