On July 16th the FDA announced
plans to consolidate aspects of its oncology activities. Once
implemented, these actions will be a positive step in an
on-going effort to enhance the efficiency, predictability, and
consistency of the clinical development path for state of the
art cancer research.
According to the official press
release, the FDA will create a new Office of Oncology Drug
Products with control over an array of biologics, drugs and
imaging technologies. Such expanded and centralized
jurisdiction is intended to streamline the review process so
that safer and more effective drugs can get to patients
sooner.
The new office will be led by
an oncology expert with an understanding of drug development
identified through a national search scheduled to begin later
this summer. As a subset of the office, the FDA plans to
create an “Oncology Program” designed to better coordinate and
integrate cancer-related activities throughout the agency such
as regulatory policy and cross-agency consultations. Similar
to the other drug evaluation offices (typically referred to as
ODEs) in the Center for Drug Evaluation and Review (CDER),
this office will be housed within the Office of New Drugs.
Previously, the jurisdiction over oncology drugs, biologics,
and imaging products in CDER was spread out among 3 different
offices, none of which focused exclusively on cancer.
The FDA’s proposed changes will
consolidate much of CDER’s review authority over cancer
products into a single office dedicated entirely to oncology.
Over the past several months, Friends has been working
alongside and in concert with top cancer research scientists,
advocacy leaders and professional society directors to
generate ideas and momentum for improving the review of cancer
products.
Representatives from the FDA,
including Acting Commissioner Dr. Lester Crawford and Deputy
Commissioner Dr. Janet Woodcock, have welcomed such input and
feedback over the past several weeks from many members of the
cancer community. Because cancer is a serious and potentially
life threatening disease that strikes roughly one out of every
three Americans, cancer patients and those at risk deserve the
most efficient evaluation process possible for new oncology
products that might improve their care or reduce their risk.
We feel that this FDA
announcement is a vital first step that promises new hope and
new science to patients in desperate need. Moreover, we are
encouraged by the FDA’s plans to provide an evaluation
mechanism that will gauge the effectiveness of these initial
reforms for improving the FDA’s approach to oncology products.
