Implications of the FDA’s
Program Alignment Plan
In late 2013, the FDA announced it was embarking upon a program to realign its tructure and programs to keep up with the challenges posed by advances in science, globalization, and product complexity. By Feb. 2014,
FDA Commissioner Margaret Hamburg, M.D.,
had unveiled the sweeping changes to the agency
that will see its many divisions reorganize to
become more specialized.
An internal Program Alignment Group (PAG) was
tasked with charting a course for modifying agency
functions and processes. The PAG strongly recommended that regulatory and compliance activities
be organized around distinct commodity-based and
vertically-integrated regulatory programs, including:
pharmaceutical quality — for drugs and biologics regulated by the Center for Drug Evaluation and Research
(CDER) and veterinary drugs; food and feeds; medical
devices and radiological health; products regulated
by the Center for Biologics Evaluation and Research
(CBER); tobacco; and Bioresearch Monitoring (BIMO).
These programs will have governance and budgets to
ensure that resources are allocated to strategic priorities,
and that the FDA speaks with one voice on policies and
operations related to any given commodity. Specific to
CDER, the division has published a timeline and plan
for addressing the realignment activities1. Although the
plan is only a framework, it does provide a glimpse of
the FDA of the future.
Most notable is the emergence of the Office of
Regulatory Affairs (ORA) as a focal point for the
transformation to a commodity-based structure.
The ORA is the lead office for all agency field
activities. ORA inspects regulated products and
manufacturers, conducts sample analyses of regulated products, and reviews imported products
offered for entry into the U.S. The intent behind
this new strategy is to drive greater alignment
between ORA and the Centers. This has been a
perennial issue for decades although consistency
between the district office and the Centers has
been steadily improving. The PAG also advocates
the establishment of more specialized resources
with ORA taking responsibility for creating an
educational and training architecture.
The transformation to a commodity-based vertical
will mean reapportioning internal resources and redefining oversight and management. This is never a quick
and easy undertaking in a government agency.
The final major takeaway from the program alignment plan is the commitment to outcome-based
metrics. The PAG recommended that each Center
be charged with constructing a new program-based
work planning regime to base compliance activities on
risk factors, public health outcomes, past inspectional
history, and operational experience. Those activities
are to be tracked with performance-based metrics
clearly demonstrating public health and compliance outcomes. Metrics have been part of the FDA’s
toolkit internally for some time, starting with the
FDA-TRACK program that measures departmental
performance against strategic initiatives. This new
vision extends this philosophy, particularly to imports
where the agency has implemented its PREDICT2
(Predictive Risk-based Evaluation for Dynamic
Import Compliance Targeting) electronic screening
tool for import operations. The new plan calls for
the Center to share its PREDICT evaluation data and
adjust its risk scores appropriately to align itself with
this new strategy.
The next few years will be telling as the FDA
moves to implement this modern vision of a commodity-based organization. Its effectiveness depends
on how turbulent the next five years will be for the
industry. It falls upon the Centers and ORA to shore
up their capabilities to meet the technical and scientific challenges of the new global market.
Bikash Chatterjee, President and Chief Science Officer
of Pharmatech Associates, has been involved in the biophar-maceutical, pharmaceutical, medical device, and diagnostics
industry for over 30 years. His expertise includes site selection, project management, design, and validation of facilities
for U.S. and European regulatory requirements.