On his last full day as FDA commissioner, Robert Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur its director.
The process of forming the center began in June, and Pazdur has been the acting director. Reorganization of the FDA oncology portfolio is an element of the Obama White House Moonshot Initiative.
The underlying issue isn’t new. For over a decade, cancer groups have been lobbying to combine all FDA cancer expertise in one administrative unit.
Though Califf announced this change on his last day at the agency, his action signals that Pazdur’s vision of how drugs should be developed and approved will survive transition to the Trump administration.
“This is it! We did it! I am thrilled,” said Ellen Sigal, chair and founder of Friends of Cancer Research, who spearheaded the effort to form the center. “It’s fully authorized, the intention is to get it fully funded, and we are now into implementation.”
The change also suggests that the agency is considering reorganizing around therapeutic areas. Currently, therapies are spread out to centers of drugs, biologics and devices.
“This is establishing a model for approval of therapies by teams of experts with the expertise in a disease setting,” Sigal said to The Cancer Letter.
FDA officials said the agency will use $3.6 million of its existing funds for initially forming the oncology center. However, another $75 million over five years is expected to wind its way through NIH and NCI (The Cancer Letter, Dec. 10, 2016).
Reorganization of FDA’s oncology unit was viewed as one of the most achievable and least costly goals of the White House moonshot (The Cancer Letter, Feb. 26, 2016).
Vice President Joe Biden personally announced the center last June (The Cancer Letter, July 1, 2016).
Pazdur is widely viewed as a visionary in the field, and is widely supported by academics, advocacy groups and the industry. As a result, Califf was lobbied to start the oncology center, overcome internal resistance to change and place Pazdur at the helm of the agency’s consolidated unit (The Cancer Letter, June 10, 2016).
In an interview with The Cancer Letter reporter Matthew Ong in June 2016, Pazdur, a gastrointestinal oncologist who joined the agency in 1999, described his vision for the oncology center and the FDA (The Cancer Letter, July 1).
“I’ve always had a vision to enhance collaboration and focus our work in oncology here at the FDA in disease-specific teams. That was one of the first things I did when I became the director of what was then the Division of Oncology Products in CDER, and I think the OCE is a continuation of that across medical products.
“This OCE builds upon the collaborative work that the oncology team at FDA has been working toward. For example, one model that has worked well in the past is holding cross-center monthly meetings to discuss key oncology issues, collaborative workshops and programs, and working together on research and scientific publications.
“I am also honored to help facilitate engagement externally with oncology stakeholders, including patient-focused advocacy groups, professional associations, industry, academia, sister agencies such as the National Institutes of Health and international regulatory agencies. The FDA has incredibly strong partnerships in oncology that we look forward to building upon through the OCE.
“Anyone who knows me knows that two things at the heart of what I try to bring to the table are the patient voice, and fostering innovation. At the FDA, the patient voice is an integral part of our regulatory decision-making, based on professional responsibility and personal experience. This will continue to be valued in the work of the OCE across oncology-related products.
“At FDA, we support innovation and believe that multiple treatment and diagnostic options are in the best interest of patients. I look forward to continuing to support the agency’s mission in this regard.”
Reacting to the agency’s announcement, Clifford Hudis, CEO of the American Society of Clinical Oncology, said Pazdur has provided fundamental, intellectual and regulatory guidance to the enterprise of drug development.
“We commend the Food and Drug Administration for establishing the Oncology Center of Excellence with Dr. Richard Pazdur as its director,” Hudis said to The Cancer Letter.
“The FDA has provided not only regulatory guidance but also intellectual leadership in the development of oncology products and this new OCE will build on that past, creating a larger community of scientists and clinician experts within the agency. ASCO looks forward to working with the OCE and the new administration to help improve the lives of people living with cancer.”
The text of Califf’s announcement of the formation of the center, dated Jan. 19, follows:
Today, the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers.
The FDA is taking important steps to formalize the structure and implementation of the OCE as part of its overarching effort to better address the needs of cancer patients, through reorganization within the FDA’s Office of Medical Products and Tobacco.
While the review criteria and application requirements for medical products, as well as the work of review staff in the centers will not change, uniting experts to collaborate on the clinical review of oncology products will enhance the agency’s work in approving safe and effective cancer products.
In addition, the FDA’s Oncology Center of Excellence will improve the agency’s ability to advance oncology-related regulatory science and policy and streamline stakeholder engagement.