The Food and Drug Administration intends to move forward with plans to partner officials in different agency centers with expertise in products affecting cancer in an effort to streamline the review process.
President Barack Obama’s proposed fiscal year 2017 budget includes a request for $75 million as part of Vice President Joseph R. Biden Jr.’s cancer moonshot initiative to establish a largely virtual Oncology Center of Excellence at FDA. Agency Commissioner Robert Califf, speaking at a recent event, said the agency would begin creating such a center regardless of whether Congress mandates the change or provides additional funding.
“The big deal for the FDA here is a lot of public pressure here to create a Center of Excellence in Oncology and we’re going to do that whether it’s part of legislation or not,” he said.
FDA is not looking to change the primary review process, Califf said, but to streamline it. “We’re hopeful this will lead to more efficient, more responsive regulation,” he said. Right now, review of new cancer treatments occur across the drug, device and biologic centers within FDA, a system advocates say is not ideal.
“If you can establish the FDA today, you probably wouldn’t have it organized the way it is,” Jon Retzlaff of the American Association for Cancer Research, said in a recent interview.
Treating cancer, for example, increasingly relies more on advanced diagnostic tests, currently reviewed at the device center. Those reviews, proponents argue, would benefit from the input of FDA officials with oncology expertise in the drug or biologic centers.
That’s the goal of the White House and the agency: to break down silos between the institutions and tap into the product and disease-specific knowledge of regulatory scientists and reviewers.
Between Oct. 1, 2016 and Sept. 30, 2017, FDA plans to begin to establish the structure of the virtual center and begin to staff it.
Focus on Coordination
The Office of Hematology and Oncology Products within FDA’s drug center has cultivated a reputation for quick reviews – a trait attributed in part to its director, Richard Pazdur.
Under Pazdur, teams are more focused on individual cancer strains, allowing those with specific expertise to work together, said FDA consultant Grant Williams, who spent 16 years as a cancer drug reviewer at the agency.
But the increasing reliance on different treatment modes to treat cancer requires reviews outside of just the oncology office, according to Jeff Allen, executive director of advocacy group Friends of Cancer Research. “What we are seeing now is that now the treatment of cancer is evolving,” Allen said in a recent interview. “It’s really kind of a treatment journey that uses all of these different types of intervention.”
Many new cancer drugs, for example, will be cell-based therapies, which would usually fall under the FDA’s biologic center. A streamlined review system between centers, advocates argue, would allow the agency to capitalize on the expertise that resides across FDA, such as in the oncology center, to ensure products are reviewed in a timely manner.
By taking a more disease-oriented approach, Allen says, the standards that are applied to different technologies could be implemented consistently across the agency. The goal, proponents say, is to use the oncology center as a model and expand it out to different disease areas.
“We have to keep up with the scientific advances,” AACR’s Retzlaff said. “That requires a team of experts of all kinds of different areas probably looking at specific diseases.”
A bill included in the Senate health committee’s counterpart to the 21st Century Cures (HR 6) legislative package that would improve FDA’s hiring abilities also includes a provision that may speed the process along.
The measure would require FDA to establish one or more Intercenter Institutes focused around major disease areas. That center would be charged with coordinating activities between the drug, biologic and device centers.
And while funding to implement such a process remains a potential roadblock, advocates believe there is progress that can be made in absence of more money. “I think there are a lot of things that can be done now in terms of improving coordination around some of these activities, but with additional resources obviously they’ll be able to do more with that,” Allen said.