publication date: Jul. 1, 2016

Biden Announces FDA Center of Excellence 

Vice President Joe Biden announced the formation of the FDA Oncology Center of Excellence, which is intended to consolidate the agency’s cancer portfolio and streamline regulatory pathways for cancer-related drugs, biologics, and devices.

Richard Pazdur, currently the director of the Office of Hematology and Oncology Products, will serve as acting director of the agency’s new cancer center.

Biden’s June 29 announcement at the National Cancer Moonshot Summit in Washington, D.C. follows months of lobbying by oncology professional societies, advocacy and patient groups.

These groups are now watching to make sure that OCE would have a concrete reporting structure to bring all cancer-related products—now regulated separately in three centers in different divisions—under one roof.

In the past, the agency and the Obama administration said that the new center could be “virtual,” i.e. that desks may not need to be moved. The V-word didn’t figure in either Biden or FDA’s announcements June 29 (The Cancer Letter, May 6).

As acting director, Pazdur now has some authority to formalize who and what goes where in a potential agency-wide reshuffle of oncology resources.

Pazdur is expected to coordinate with the agency’s three centers—the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health—and report to FDA leadership on the structure of the program.

“Center directors from CDER, CBER, and CDRH will work alongside Dr. Pazdur in his role as OCE acting director to formalize an innovative, yet seamless cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics and medical devices,” FDA Commissioner Robert Califf said in a statement June 29.

The White House moonshot directive for an integrated cancer center comes with $75 million—which advocates say is insufficient—in new mandatory funds for FDA in the 2017 fiscal year (The Cancer Letter, Feb. 12).

“We will be asking for appropriations for this, obviously,” Pazdur said to reporters at the National Cancer Moonshot Summit at Howard University June 29. “I think the structure has to dictate what our funding requirements will be and that’s yet to be defined, and how much is going to be borrowed from other centers, etc., as we establish this office.”

An acting director will be selected to replace Pazdur at the Office of Hematology and Oncology Products.

Despite its title, the Oncology Center of Excellence is a program, not a center equivalent to CDER, CBER, or CDRH.

“We don’t have a deadline, and what I’m more interested in doing is making sure that everybody’s voice is heard,” Pazdur said. “One of the first things that I want to do at this point really is to sit down with a review staff.

“No one likes change. My late wife used to say that the only person that loves change is a baby with a wet diaper. Unless you have everybody on board with this, it can’t work in an optimal fashion.”

In earlier months, the proposed consolidation appeared to run into internal opposition at FDA, particularly in units that stand to lose authority, staff and budget in the potential reorganization.

In a statement to The Cancer Letter at the time, FDA leadership said that it would establish the staffing and structure for a “virtual” cancer center in fiscal 2017, triggering an outcry from cancer groups that demanded speedier decision-making (The Cancer Letter, May 6).

In one of his chatty asides at the summit June 29, Biden said he exerted pressure over a federal agency that was dragging its feet on appointing a “new director” until the end of the year.

“I won’t mention the particular agency, but we’ve had, one of the agencies in the federal government said they’re going to get a new director, and said ‘We’ll have it by the end of 2016,’” Biden said.

“I called the head of that department in and said, ‘[End of] 2016? It is now June. If you can’t get that director in the next four months, tell me, we’ll go find someone else who can find them.’

“It’s bizarre. Some of your actions are like that: we can do it later.”

At 8:10 a.m., a few hours before Biden spoke at the moonshot summit, FDA announced Pazdur as acting director of the OCE.

“After a competitive internal search, I can think of no one more qualified to shepherd the agency into a new era of regulation over oncology products than the FDA’s own Dr. Richard Pazdur, who has led the FDA for nearly 20 years in reshaping and modernizing the review of cancer treatments,” Califf said in the statement June 29. “Dr. Pazdur is the person the FDA needs to get the OCE up and running, because of his in-depth understanding of the inner workings of the FDA, his deep expertise in treating this complex disease and his ability to move the agency forward in this complicated task.

“We look forward to Dr. Pazdur’s and the center directors’ work to lead the FDA in rapidly implementing the cross-cutting efforts of the OCE in this initial phase.”

 

Cancer Groups: Pazdur is the “Perfect Pick”

Pazdur is the “perfect pick” to lead the OCE, said Ellen Sigal, chair and founder of Friends of Cancer Research, the organization that led the advocacy effort to create the program.

“Working with the Vice President on this initiative has been inspiring,” Sigal said to The Cancer Letter. “To see him help lead the moonshot, especially the creation of the Center of Excellence, proves that even in a gridlocked Washington, many are willing to put differences aside for the benefit of patients.

“By naming Dr. Pazdur, one of our country’s most dynamic scientific leaders, to head the center, the vice president and the FDA has signaled to the community how important this is to the broader moonshot goal of curing cancer.”

On June 6, 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 (The Cancer Letter, June 10).

FDA should make Pazdur the permanent director of the OCE, not just acting director, the American Association for Cancer Research said in a statement.

“It was especially gratifying to hear that the FDA has selected Dr. Rick Pazdur to lead this important new Oncology Center of Excellence, and we look forward to the FDA designating him as its permanent Director very soon,” AACR CEO Margaret Foti said. “Dr. Pazdur has worked tirelessly to speed the availability of therapies for cancer patients, especially when the drugs are the first available treatments or have advantages over existing therapies.

“In addition, Dr. Pazdur has worked for years to build collaborative partnerships with academia, industry, other government agencies, scientific societies, and patient advocacy organizations to improve the pace and quality of new cancer drugs reaching patients. He also has embraced regulatory science to truly inform and improve the way in which new cancer medicines can be evaluated for their safety and efficacy.”

On an annual basis, approximately 30 percent of all new drugs approved by FDA are oncology products. Pazdur is widely credited for reforming and creating the existing processes for regulating anticancer drugs.

Pazdur’s office has approved many novel treatments that have extended the lives of patients and markedly improved their quality of life, said Daniel Hayes, president of the American Society of Clinical Oncology.

“ASCO commends FDA Commissioner Dr. Robert Califf for his selection of Dr. Richard Pazdur to lead the agency’s new Oncology Center of Excellence,” Hayes said in a statement. “In his nearly 20 years with the FDA, Dr. Pazdur has worked innovatively to dramatically reduce the amount of time to review new products and increase the number of safe and effective oncology products available to cancer patients. He consistently demonstrates the necessary leadership and commitment to improving cancer care for directing this new center to carry out its mission.

“ASCO applauds the remarkable success of the FDA in regulating oncology products. However, we believe a more coordinated approach will further streamline and organize evaluation of oncology products—both therapeutic and diagnostic. We have been supportive of calls for development of Centers of Excellence within the agency that globally review all aspects of a single disease, and we are pleased that Dr. Pazdur has been appointed to direct the oncology center.

“The oncology center is coming at a crucial time in response to the need to coordinate review of drugs, diagnostic tests, and other types of devices,” Hayes said. “This large-scale agency reorganization will require a great deal of vision and planning to ensure that the new center fully achieves its goals of bringing safe and effective oncology products to market more efficiently. There is no better person to lead this effort than Dr. Pazdur.

“ASCO is very supportive of the new FDA Oncology Center of Excellence and the selection of Dr. Pazdur to lead it. We are ready to work with Dr. Pazdur and the FDA as this new center is formed and works to meet the needs of people living with cancer.”

Pazdur is a “natural fit” for the OCE, the American Cancer Society Cancer Action Network said.

“We congratulate Dr. Pazdur on his appointment,” ACS CAN said in a statement said to The Cancer Letter. “As the head of OHOP at CDER, he has provided strong leadership and a dedication to advancing regulatory science and innovative review pathways within FDA, while maintaining a focus on the needs of cancer patients.

“He is a natural fit to lead the newly formed Oncology Center of Excellence and we look forward to working with him as the new Center is created.”

Pazdur’s appointment will amplify FDA’s work on pediatric oncology, said Nancy Goodman, executive director and founder of Kids v Cancer.

“It’s just terrific for children with cancer that Dr. Pazdur is appointed acting director of the cancer center,” Goodman said to The Cancer Letter. “The next step will be to establish the center as an integrated cohesive whole that can quickly and fully respond to scientific advances.”

The OCE is the first step to ensuring the rapid and timely approval of safe and effective treatments, said AACR President Nancy Davidson, director of the University of Pittsburgh Cancer Institute.

“It is important for the FDA to be structured and managed in a way that enables it to respond in a much more coordinated way to the needs of cancer patients, the interests and goals of cancer drug and test developers and manufacturers, and the rapidly changing scientific environment, as we have seen in the areas of companion diagnostics and next-generation sequencing (NGS) tests,” Davidson said. “Therefore, we believe that this is a prudent move by the FDA to establish this new Oncology Center of Excellence.”

 

 

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