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Inside Health Policy – FDA Taps Pazdur To Head Oncology Center, Seeks To Establish ‘Navigator’ Program For Expanded Access

Inside Health Policy – FDA Taps Pazdur To Head Oncology Center, Seeks To Establish ‘Navigator’ Program For Expanded Access

FDA tapped the director of the Office of Hematology and Oncology Products, Richard Pazdur, to head the agency’s new Oncology Center of Excellence that will focus on uniting cancer product regulatory review and leverage clinical expertise across FDA as part of the vice president’s Cancer Moonshot Initiative. As part of this scheme, the agency is also scaling up efforts to provide accessible and time-saving information to physicians and patients pursuing expanded access requests for investigational drugs.

The agency’s plans were announced Wednesday (June 29) along other activities that the Cancer Moonshot Task Force and individual federal agencies plan to undertake to support Vice President Joe Biden’s initiative. Biden also hosted a Cancer Moonshot summit as part of a national day of action Wednesday that includes more than 270 events in communities across the country.

As acting director of the new center, Pazdur is charged with quickly establishing a program that brings together oncologists across FDA in an effort to expedite the development of novel cancer-related drugs, biologics and devices. But stakeholders said there is more to do now that the center has been announced, noting the upcoming transition to a new administration.

Stakeholders, including a former FDA official and the founder of Friends of Cancer Research, discussed potential cross-center institutes of excellence that could help FDA further advance the promotion of human health at the DIA annual meeting in Philadelphia Tuesday (June 28).

Former director of FDA’s drug center, Steven Galson, said that to keep the newly established oncology center moving forward, the agency needs a project plan with dates and commitments, adding that charting the center out and getting people committed to the plan would give the center a life of its own during the transition to a new administration.

Founder and chair of Friends of Cancer Research Ellen Sigal said FDA needs resources and an improved hiring capacity. She pointed to language in the House-passed 21st Century Cures Act and the Senate’s complementary legislative package that would lift hiring caps and raise salary caps for senior level scientists and researchers at the agency, as well as allow FDA to hire these staffers directly.

FDA is also building up its efforts to provide information for physicians and patients seeking expanded access to investigational drug treatments in cases of serious or life-threatening conditions. The agency recently finalized a simplified form to make the process easier for physicians to request experimental drugs for patients. The agency also released guidance to make the process clearer and said requiring a full institutional review board review could deter patient access while other options might better facilitate it.

The agency is ramping up efforts to establish a “navigator” program to serve as a connection point between patients, providers and drug developers to facilitate expanded access requests.

Other government activities under the Cancer Moonshot Initiative include CMS’ enrollment of nearly 200 participating physician practices, including more than 3,200 oncologists, in its multi-payer Oncology Care Model.

“Participants constitute a geographically, clinically, and organizationally diverse group of practices providing roughly $6 billion in care for an estimated 155,000 beneficiaries per year during the five year model who have committed to providing enhanced services to Medicare beneficiaries such as care coordination and navigation,” a fact sheet on the Cancer Moonshot announcements states. “These practices also agree to use national treatment guidelines for care and CMS will supply practice feedback data for continuous care improvement.”

Another activity aims to cut in half the time it takes to review patent applications in select fields of cancer therapy. The U.S. Patent and Trademark Office is launching a free and accelerated pilot program this month, and this “fast track” will be open to any applicant, including early stage biotechnology companies, universities and large pharmaceutical firms alike. Entities that have products already in FDA approved clinical trials will be able to opt into the acceleration program.

The vice president’s announcement also includes details of private sector commitments in response to Biden’s call to action. The National Patient-Centered Clinical Research Network announced the creation of a planning group composed of patients, clinicians and investigators that will identify the nation’s top cancer research questions; develop approaches for real-world electronic data to address unmet research needs; and reduce disparities in cancer care and outcomes.…