Executive Summary
Center for Drug Evaluation and Research’s long-time director of oncology/hematology products office will continue as signatory on drug reviews even after new Cancer Moonshot-driven structure takes effect.
FDA’s new Oncology Center of Excellence will not take Richard Pazdur away from his drug approval duties.
Pazdur, who is the acting director of the new agency center intended to integrate all aspects of review for cancer therapies, said he also will remain as director of the Office of Hematology and Oncology Products within FDA’s Office of New Drugs.
Richard Pazdur’s decision to continue directing drug reviews will help maintain the status quo within CDER’s oncology divisions.
“The concept that we have developed at the present time is that for the CDER applications, I will be maintaining my position as director of OHOP and therefore be signing off on those applications,” he said Nov. 4 during the BioPharma Congress, cosponsored by Prevision Policy and Friends of Cancer Research.
As the transition to the center of excellence set-up is completed and encompasses relevant applications in the drug, biologic and device centers, the oncology center of excellence “will be signing off clinical reviews of those,” but the biologics and device centers “will retain the ultimate signatory authority since they have integrated the other properties of the drug approval process, i.e., manufacturing, toxicology, pharmacology, etc.,” Pazdur said.
Part Of Moonshot Initiative
The Oncology Center of Excellence at FDA is part of the federal Cancer Moonshot initiative, which is designed to boost efforts to find cancer cures by marshalling the oncology resources of FDA, National Institutes of Health and other agencies to work better together.
At FDA, the center of excellence will integrate the drug, biologic and device experts for evaluation of products to prevent, screen and treat cancer.
Pazdur was named as the center’s interim head in June, and the new organization is expected to launch in the next few months.
His decision to remain head of the oncology drug review division is a surprise. It was expected that he might turn over the Office of Hematology and Oncology Products to a colleague while running the center of excellence. (Also see “FDA’s Pazdur Jumps Over To New ‘Moonshot’ Role” – Pink Sheet, 29 Jun, 2016.)
However, the news that Pazdur intends to continue directing oncology drug reviews should please sponsors because it will help maintain the status quo within the oncology divisions. Sponsors are familiar with the expectations that Pazdur has set for oncology drug development, and he is well-respected both inside and outside the agency. (Also see “FDA Oncology Advisory Committee Is Still Pazdur’s Center of Excellence” – Pink Sheet, 20 Sep, 2016.)
The Cancer Moonshot is awaiting funding from Congress, which could be included in the pending 21st Century Cures legislation, although FDA already has the funds to launch the center of excellence. (Also see “FDA Oncology Center Of Excellence Coming, Moonshot Or Not” – Pink Sheet, 20 Apr, 2016.)
Focus On Clinical Aspects
The Oncology Center of Excellence will consolidate only the clinical issues surrounding the review and approval of new cancer therapies. Manufacturing issues for those therapies will remain with the appropriate offices within FDA, Pazdur said.
“The Oncology Center of Excellence is going to focus on the clinical evaluation of patients and of the drugs that come in,” he said. “Manufacturing issues and expertise of manufacturing, whether it be drugs, biologics, or the … properties of devices will reside in those centers.”
The Oncology Center of Excellence will consolidate only the clinical issues surrounding the review and approval of new cancer therapies.
By bringing together drug, biologic and device staff under one umbrella, Pazdur can ensure reviews of the various components of an application, such as a drug and device, move in parallel.
A common complaint has been that delays develop because the timelines between the drug and device centers are not aligned, sparking calls for FDA to change its handling of combination product applications. (Also see “FDA’s Combo Products Review Transformation Begins” – Pink Sheet, 24 Aug, 2016.)
Center for Drug Evaluation and Research Director Janet Woodcock said during the conference that sponsors should see a somewhat seamless transition to the new organizational structure. The affected product centers (CDER, along with the biologics and device centers) will share the combined cadre of oncologists as needed rather than continue maintaining their own groups, she said.
Woodcock also said that since oncologists do not specialize in drug manufacturing, it is important that quality control remain with the offices that specialize in that area.
FDA likely does not have the staff to dedicate manufacturing and facility experts to oncology and related products. However, having them outside the center of excellence could make it more difficult to ensure everything moves in tandem.
Pazdur said as the center of excellence is built, he will work to make sure all office directors and staff are included.
“I think the issue that we need to focus on here again is how we develop a cohesive work environment for oncology in the agency,” he said. “Part of our process here is really to work together with the center directors to ensure a transition here where all parties are heard, all voices are heard and the least disruptive type of environment is established at the beginning.”
CDER launched the Office of Pharmaceutical Quality in 2015 to place manufacturing and related drug quality issues under one roof. (Also see “Woodcock’s Passion Project: CDER Chief Shifts Duties To Lead Quality Office” – Pink Sheet, 19 Jan, 2015.)
FDA’s Office of Regulatory Affairs also is undergoing a reorganization to better align its inspectors with the product centers. Rather than being organized by geography, ORA will be organized by product type, such as drugs or devices. (Also see “FDA Adding Managers, With Goal Of Quicker Inspection Reports” – Pink Sheet, 30 Sep, 2015.)
Structure Likely Will Be Fluid
Pazdur also warned that the initial structure of the Oncology Center of Excellence may change in two to five years.
“I think it’s important that we realize that part of this vision is really a greater interaction with the outside world and really to make it a patient-focused agency,” he said.
Pazdur also said he wants to incorporate staff career development into the set-up. He has long advocated that FDA adopt a more academic focus as it tries to recruit and retain staff. (Also see “FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?” – Pink Sheet, 30 Nov, 2015.)
CDER has hundreds of openings that it has not filled. The upcoming reauthorization of the prescription drug user fee program will include some changes to help find new staff.
User fee funds will be set aside to support adding 230 new full-time equivalents, including some for FDA’s Center for Devices and Radiological Health. (Also see “PDUFA First: Fees To Support Device Center Staff” – Pink Sheet, 24 Aug, 2016.)
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