New Drug Approvals in 1992

New Directions for FDA's Center for
Biologics Evaluation and Research (CBER)
By Kathryn C. Zoon, Ph.D., Director, CBER, and
Michael G. Beatrice, Associate Director for Policy, CBER

The past year at the Center for Biologics Evaluation
and Research (CBER) has been dominated by
change. The selection of a new Center Director,
the design and implementation of a major reorganization, the
design, passage and partial implementation of the Prescription
Drug User Fee Act of 1992, and the establishment of several
major new policy directives have kept CBER very busy and
challenged.
CBER's mission is to protect and enhance the public health
with respect to the blood supply, vaccines and biologic therapeutics. The advances of biotechnology in the past decade
and the exciting technologies of the 90s, including gene and
somatic cell therapy, have crosscut all areas of CBER's
regulatory responsibilities. As shown in the graph titled
"Biotech INDs Received Compared to Total," the workload
for new investigational biologic products produced by biotechnology has increased dramatically from less than 5 INDs
in 1980 to more than 300 in 1992. (INDs are requests from
researchers to FDA for permission to test experimental
medicines in people.) The major growth area continues to be
in therapeutics, as shown in the graph titled "INDs Received
by Category." This increase has made us acutely aware that
CBER must change in order to meet the new scientific and
regulatory challenges of tomorrow. This article summarizes
some of the new directions CBER has taken over the last year
in order to facilitate and enhance our ability to meet these
challenges.
Biotech INDs Received Compared to Total
600
500
400
300
200
100
0
FY: 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992
UAll INDs D Biotech INDs
Since the appointment of a new Director of CBER in March
1992, senior management and the CBER staff have worked to
develop and implement several major initiatives. The first new
direction was the restructuring of CBER, following a CBER
Listening Initiative and Senior Management Retreat. The
objectives of the reorganization were to 1) optimize and
streamline the biologics review process, 2) delegate authority
and responsibility down into the organization, 3) maintain
and build strong scientific programs, 4) better integrate
research and review functions, and 5) maintain and build a
strong and vigilant postmarketing program.
The Office of the Center Director has been reorganized to
include three associate directors and a special assistant. The
purpose of the Office of the Director is to provide leadership
and ensure consistency in policy, research, and international
affairs across all offices, as well as the coordination of complex issues which require participation of multiple offices.
The three product-specific offices in the new organizationthe offices of Therapeutics, Vaccines and Blood Research and

Review-are responsible and accountable for the research
programs and product-related regulatory assignments under
their purview. The duties of the offices of Establishment
Licensing and Product Surveillance, Compliance and Management crosscut all other offices and each other. A consolidation of several new working units also will take place in
January 1993.
INDs Received by Category
350

300

AML
~
250
200
150
100
50
0 L
FY: 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992
U Therapeutics iaVaccines D Blood
The passage of the Prescription Drug User Fee Act of 1992
gives CBER the prospect of collecting fees dedicated to obtaining
resources to expedite the review process. Following Congressional passage of a supplemental appropriation, CBER can
begin hiring an additional 300 positions and enhance both
review and support activities, including project management
and information management. (See the article on user fees on
page 9.)
In addition, CBER is pursuing several important new initiatives that encompass the areas of policy, training, information
management and project management. Major resource commitments have been implemented to establish reviewer training
and improve tracking systems for both INDs and product
licensing applications (PLAs).
CBER management has worked hard to facilitate an orderly
transition into its new structure while maintaining the quality
of its scientific and regulatory programs. We pledge to continue to provide leadership and support to meet the many
challenging activities that the future holds.
CBER's New Organizational Structure

Director
Special Assistant
Associate Director for Research
Associate Director for Policy
Coordination and Public Affairs
Associate Director for Medical and
International Affairs

Office of
Management

i

Office of
stablishment
Licensing &
Product
Surveillance
Divisions
Divisions

Office of Office of Office of Office of
Vaccines Therapeutics Blood Compliance
Research and Research & Research &
Review Review Review
Divisions Divisions Divisions Divisions
Divisions Divisions Divisions Diviions