The FDA Oncology Center of Excellence—first proposed in the National Moonshot Cancer Initiative—is gaining support from oncology groups as well as in both chambers of Congress.
Earlier this week, 28 oncology professional societies and advocacy organizations sent a letter to FDA Commissioner Robert Califf, describing the organizational structure they’d like to see in the proposed center.
Dated June 6, the proposal was signed by the American Society of Clinical Oncology, the American Association for Cancer Research, the American Cancer Society, the Association of American Cancer Institutes, and Friends of Cancer Research.
Two days later, on June 8, Reps. Fred Upton (R-Mich.) and Frank Pallone (D-N.J.) introduced the FDA Cross-Center Collaboration Act, which mandates the creation of one or more FDA “Intercenter Institutes.”
Similar language was included in the Senate companion bill to the 21st Century Cures Act, a legislation designed to speed up drug development, modernize clinical trials and accelerate approval of drugs and medical devices. The FDA and NIH Workforce Authorities Modernization Act was introduced March 17 by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.).
Both measures emphasize coordination of staff from existing FDA centers—across drugs, biologics, and devices—in accordance with major disease areas.
Presumably, this would begin with cancer. Leaders in academic oncology, patient advocacy, and industry agree that the intercenter approach should first be tested in oncology, because the field is well developed to serve as a “regulatory incubator.” (The Cancer Letter, Feb. 26.)
FDA is “actively and expediently” working on the issue, officials said in a statement.
“Planning meetings have already begun internally at the FDA for the Oncology Center of Excellence involving the Commissioner, the Associate Deputy Commissioner for the Office of Medical Products and Tobacco, along with directors of Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and Center for Devices and Radiological Health, and the FDA is holding listening sessions to gain input from health care professional and patient advocacy groups, as well as industry, to inform our approach,” FDA said in a statement to The Cancer Letter. “We value and appreciate the input from these groups.
“While the details of the specific framework of this Oncology Center of Excellence are still in the process of being developed, the FDA is actively and expediently moving forward in this important work and will share more information when possible. The FDA looks forward to working across FDA centers, the federal government and the private sector to tackle this devastating disease that touches so many American families.”
The entire controversy boils down to the interpretation of one word: Virtual.
According to afact sheet that accompanies President Barack Obama’smemorandum on the moonshot, “the FDA will develop a virtual Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.” (The Cancer Letter,Feb. 5.)
This directive comes with $75 million in new mandatory funds for FDA in fiscal 2017.
However, the word virtual is conspicuously absent from the letter to FDA, the agency’s response, and the Senate and House bills.
In place of “virtual,” oncology groups are suggesting that FDA integrate “clinical personnel from all centers into the existing disease-specific teams to ensure consistency” and consolidate “review processes, including review by a single clinical and single statistical team.”
“All disciplines that contribute to the clinical assessment of the disease-specific therapeutic or in vitro diagnostic product fall under the authority of the Director of the Oncology Center of Excellence,” the groups wrote in the letter to Califf. “Other aspects of product review not associated with benefit-risk assessments (i.e. patent issue, naming, etc.) should remain separate.”
The House bill aims to streamline the review of drugs and devices for major disease areas across product centers, said Reps. Upton and Pallone in a statement June 8.
“With this bipartisan effort, each Intercenter Institute would be primed to coordinate activities and convene the right scientific and regulatory experts to help solve challenges that are unique to specific conditions and diseases,” the representatives said. “Throughout the 21st Century Cures process, we’ve seen that success is possible when we work together. This commonsense bill encourages centers to working together to help accelerate the discovery, development, and delivery of cures.”
The Oncology Center of Excellence will refocus resources for the benefit of patients, said Ellen Sigal, chair and founder of Friends of Cancer Research.
“Enhanced coordination at FDA will ensure that benefit-risk decisions are made consistently and in the context of specific diseases no matter the type of technology,” Sigal said to The Cancer Letter. “We certainly appreciate Chairman Upton and Ranking Member Pallone’s continued commitment to patients and a scientifically strong FDA.
“Seeing such strong bipartisan support on the Centers of Excellence proposal from the Senate, the White House and now the House, shows how important this is to all that seek to help patients.”
The text of the letter from the 28 oncology groups to Califf follows:
Dear Commissioner Califf,
The undersigned organizations would like to thank you and your colleagues for exploring opportunities to enhance the development and regulatory review of oncology products across all of the medical product Centers at the FDA.
The Office of Hematology and Oncology Products has indeed been the global leader in implementing rapid reviews, providing expert advice, and implementing flexible standards as appropriate. However, the scientific progress in oncology has led to increasing involvement of different Centers that regulate products involved in treating cancer.
Our hope is that the agency will take steps to improve coordination of activities and ensure that benefit-risk decisions about all cancer products are made in a uniform clinical context. We look forward to continuing to work with the FDA on areas of opportunity, and respectfully submit the ideas below for potential priorities and attributes for the Oncology Center of Excellence for your consideration.
Background
The current organizational structure of the FDA is a result of its underlying statutory authorities beginning with enactment of the 1902 when the Biologics Control Act was enacted to ensure purity of serums and vaccines for use in humans.
Over time, the Agency’s authorities have expanded including the 1938 Federal Food Drug and Cosmetic Act which established drug safety standards (and revised in 1962 to require demonstration of drug efficacy), the 1944 Public Health Services Act which provided FDA with the authority to regulate biologics, and the 1976 Medical Device amendments to the FD&C set requirements for safety and effectiveness of medical devices.
This has led to regulatory activities distributed across three medical product centers based on the product type—drugs, biologics, or medical devices. Advancements in science and an improved understanding of the molecular basis of disease has led to an evolution of medical products as accompanied by technological advances in manufacturing processes and quality assessment.
Today, the treatment of many diseases involves numerous different technologies and interventions centered on providing optimal and more personalized care for each patient. This is particularly true in cancer treatment where increased understanding of the molecular underpinnings of cancer has led to development of a host of targeted new molecular entities that have proven highly effective in many cancer types, particularly when applied with a companion diagnostic test.
As such, it is important that the FDA modernize its approach to product evaluation to improve coordination within and between the Centers that regulate the different types of medical products used in treating cancer. It is vital that the FDA assemble and coordinate a highly skilled workforce that is expert in cancer biology, clinical oncology, cancer genomics and immunology to enable the comprehensive and efficient review of new oncology products.
Until now, FDA has relied on an inter-center consult process to achieve coordination in medical product review. In October of 2015, an FDA internal report on the inter-center consult process was carried out by the commissioner’s office and identified 4 key issues regarding FDA inter-center consults between CDER, CBER, and CDRH. These issues are:
- Different policies, practices, and application types make it difficult to develop shared understanding of priorities and timelines.
- There are separate review and tracking systems between centers.
- There are unclear communication channels between centers.
- There is a lack of resources to review consults.
FDA Oncology Center of Excellence
In order for FDA to further enhance the development and evaluation of new cancer treatments, a consolidated Oncology Center of Excellence should be formed. Such a Center could assemble a highly expert workforce in cancer biology, clinical and psycho-oncology, and foster increased intellectual collaboration and a consistent FDA approach by forming teams of FDA staff with expertise in the prevention, detection, treatment and management of cancer and its impact on patients and families.
Ensuring that there is a forum for coordinating cross cutting disease-oriented activities at FDA will help consolidate core competencies to focus on scientific advancement within the agency and streamline processes for the review of oncology products.
A Regulatory Incubator
The Oncology Center of Excellence would also allow the FDA to develop a regulatory “incubator.” Oncology is a field with rapidly emerging scientific advancements as well as a greater risk tolerance due to the life-threatening nature of the diseases. This results in the need for novel approaches to address areas of high unmet medical need and creates an environment to develop and test new regulatory techniques. Through the “incubator,” novel approaches could be investigated and developed, specifically:
New Techniques in Reviews: streamlined “one review” processes to alleviate current redundancies for interventions that involve different medical product centers, use of summary reviews for supplemental applications, use of FDA/sponsor pre-application meetings prior to initiate application review.
- Advanced Regulatory Tools: new clinical trial designs, development of novel endpoints, and advanced statistical approaches.
- Elevate the Patient Perspective in Drug Development: via comprehensive patient-centered clinical measures including the identification, development and integration of psychosocial measures, and patient treatment preferences as clinical measures to be included in core data sets
- Global Collaborations: harmonization of similar international programs such as the Breakthrough Therapy Designation and EMA PRIME, harmonization of pediatric requirements.
- Optimal Oncology Workforce: improve coordination between HHS agencies, establish pre- approval meetings between FDA/NCI/CMS, and develop educational fellowships.
Potential Attributes of the Oncology Center of Excellence
- Integrated clinical personnel from all centers into the existing disease specific teams to ensure consistency in the regulation of drugs, biologics and in vitro diagnostic devices used in cancer detection, prevention, treatment, symptom management or monitoring.
- Consolidated review processes including review by a single clinical and single statistical team in the Oncology Center of Excellence as opposed to multiple clinical and statistical teams in separate centers.
- Preliminary sign-off on clinical aspects of product applications, and consider joint final sign-off for oncology products and PMAs for cancer related in vitro diagnostic devices to ensure that novel treatment options are evaluated in the appropriate clinical context.
- Primary determination of clinical requirements for Investigational Device Exemption for in vitro diagnostic devices associated with the diagnosis, treatment or monitoring of cancer.
- All disciplines that contribute to the clinical assessment of the disease-specific therapeutic or in vitro diagnostic product fall under the authority of the Director of the Oncology Center of Excellence. Other aspects of product review not associated with benefit-risk assessments (i.e. patent issue, naming, etc.) should remain separate.
- Ensure cancer specific policy decisions are harmonized with those instituted by CDER, CBER, or CDRH.
- Inclusion of psychosocial/behavioral health, patient preferences/discrete choice expertise within the Oncology Center of Excellence who will be dedicated to representing the patient voice in drug/device development, approval and monitoring.
We thank you for your consideration of these ideas and look forward to working with you as this important initiative moves ahead.
Sincerely,
Accelerate Brain Cancer Cure
American Association for Cancer Research
American Brain Tumor Association
American Cancer Society
American Cancer Society Cancer Action Network
American Society of Clinical Oncology
Association of American Cancer Institutes
The Bladder Cancer Advocacy Network
C-Change
Cancer Research Institute
Cancer Support Community
CancerCare
The Chordoma Foundation
Fight Colorectal Cancer
Friends of Cancer Research
Kids v Cancer
The Leukemia and Lymphoma Society
Lung Cancer Alliance
LUNGevity
Melanoma Research Alliance
Michael’s Mission
National Brain Tumor Society
National Patient Advocate Foundation
The Nicholas Conor Institute
Oncology Nursing Society
Ovarian Cancer Research Fund Alliance
Prevent Cancer Foundation
The Raymond Foundation
