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Inside Health Policy – Advocates Push For Separate Oncology Center At FDA To Regulate Cancer Drugs, Biologics, Devices

Inside Health Policy – Advocates Push For Separate Oncology Center At FDA To Regulate Cancer Drugs, Biologics, Devices

A group of 28 cancer patient advocacy organizations, including the American Cancer Society and Friends of Cancer Research, pressed FDA to set up a standalone Oncology Center of Excellence that includes drug, biologics and device experts to handle reviews of products designed to treat cancer. Their letter to the agency Monday (June 6) follows a proposal by Friends of Cancer Research to reorganize the agency’s centers from product specific to disease specific, and comes on as Vice President Joe Biden’s Cancer Moonshot Initiative looks to create a virtual oncology center at FDA.

The groups say that scientific advancements have led to an evolution in medical products, especially in cancer treatment. They note that new targeted molecular entities have proved highly effective in treating cancer, especially when paired with companion diagnostics.

They note that under FDA’s current structure, depending on the product type, new cancer treatments can be reviewed either in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER) or the Center for Devices and Radiological Health (CDRH).

The groups point out that FDA has relied on an inter-center consult process to coordinate medical product review, especially in the case of a combination product such as a new cancer drug and its companion diagnostic. But an October 2015 FDA internal report showed that there are issues of different policies, practices, applications, review and tracking systems, lack of resources and unclear communication between the three centers that can hinder inter-center consults.

For these reasons, the groups say, it is time for FDA to modernize its system by creating a stand-alone Oncology Center of Excellence that brings together cancer experts from CDER, CBER and CDRH to “ensure consistency in the regulation of drugs biologics and in vitro diagnostic devices used in cancer detection, prevention, treatment, symptom management or monitoring.”

“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 effective review of new oncology products,” the groups say.

Additionally the groups say the center should include staff with psychosocial/behavioral health and patient preference/discrete choice expertise who will represent the patient choice during the review process.
The Obama administration has proposed a virtual Oncology Center of Excellence at FDA as part of the Cancer Moonshoot Initiative spearheaded by Biden. The president’s 2017 budget request includes $75 million for creation of the virtual center, which according to White House fact sheet would evaluate products for the prevention, screening, diagnosis and treatment of cancer; support the continued development of companion diagnostics; and develop and promote the use of methods created through the science of precision medicine.

FDA has yet to detail how the virtual Oncology Center will be structured and how it will work in relation to CDER, CBER and CDRH.

In February, Friends of Cancer research proposed revamping FDA’s internal structure away from product specific centers like CDER, CBER and CDRH to centers that focus on specific disease areas.
“This is about the patient. This isn’t about the structure. Patients get diseases, they don’t get a biologic, they don’t get a device. It all works together. Is there a more efficient way that is better, because the goal is to get patients better treatments,” Ellen Sigal, chair and founder of Friends of Cancer Research, said at a panel discussion on the idea of disease-specific centers.

Sigal suggested starting with three or four pilot programs that include a center for oncology and could also include centers on neurodegenerative, cardiovascular and infectious diseases. She said changes should be done thoughtfully and in a stepwise approach with the appropriate resources allocated to the agency.

That proposal was backed by former-CDER director Steve Galson, who now is now senior vice president of Global Regulatory Affairs and Safety for Amgen, who said the modern world of drug development does not fit the decades-old FDA model.

“The recognition that things are dramatically different now than they were even 10 years ago, I think requires that the teamwork, which is so critical to getting products on the market today, by working as quickly and efficiently as possible,” Galson said during the panel discussion.

But former FDA Commissioner Mark McClellan argued for a slower approach. McClellan, who heads the newly formed Duke-Margolis Center for Health Policy, said it might make more sense to start smaller. McClellan threw out the idea of starting with a center for combination products, a regulatory area the agency has struggled with for years.

“My sense from that experience is the best place to start on these issues is get a sense of a priority list of problems. What are the biggest particular areas around say combination or say complex product development in the area of cancer or neurologic conditions or the like where it seems like the benefits of the new structure are likely to outweigh the risks and try to start there,” McClellan said during the February panel discussion.…