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More Effective Regulation through a Stronger Workforce is one of
five initiatives established for FDA to address five critical
challenges facing the agency.
Through this initiative, FDA will maintain a strong science-based
organization to support its risk management responsibilities
by: attracting and retaining the most talented scientists; operating
a streamlined and cost-effective agency that is optimally organized
to support mission-critical activities; and implementing the
President's Management Agenda to deliver value to our constituents.
The following is an excerpt describing this initiative from
FDA's Strategic Plan:
| Ensure a world-class professional workforce, effective
and efficient operations, and adequate resources to accomplish
the agency's mission. |
One aspect of the FDA's work has remained, and will remain, unchanged:
the critical importance of the FDA's professional workforce for
the success of the agency and for its ability to maintain the high
level of public trust in its activities. An organization that can
keep up with the rapid changes in the industries that it regulates,
and is capable of developing and implementing effective and innovative
public health measures, requires a very special workforce.
The agency's mission depends more than ever on a solid cadre of
experienced physicians, toxicologists, chemists, statisticians,
mathematicians and other highly qualified and dedicated professionals.
Their expertise is essential for making the FDA's regulatory decisions
balanced and fair, and for keeping the agency on the cutting edge
of the technology and sciences used in medicines, foods, and the
other products the FDA regulates.
As the FDA's regulatory mission grows more complex, it is only
by becoming consistently more efficient, seeking opportunities to
improve its own management, and realizing the efficiencies to be
gained from improvements in organization, infrastructure, and information
technology, that the agency can continue to accomplish its growing
and diverse mission with excellence.
The FDA's principal tool for achieving all of these goals is its
workforce. Unlike most other public health agencies, the FDA does
not achieve its health mission through grants or financing health-related
services. Instead, the FDA's principal public health resource is
its professional staff. There are almost 1,500 people with Ph.D.'s
at the FDA and more than 400 with medical degrees. The money that
the FDA is appropriated each year for its mission primarily gets
spent at the FDA on this staff. Two-thirds of the FDA's budget is
spent on its workforce. The FDA's contributions are primarily a
reflection of its professional services.
More Effective Regulation Through a Stronger Workforce: FDA's Objectives
Objective 1. Ensure a high quality, diverse and motivated workforce.
To attract and keep high-caliber employees who are responsive to
the changing needs of the agency, the FDA needs to be responsive
to their diverse needs.
There are some reasons to be concerned about whether the FDA is doing enough
to attract and develop the workforce it needs. For example,
a recent GAO analysis found that the FDA's attrition rates for
many of the people involved in its drug review process are higher
than those for other federal public health agencies and the
federal government as a whole.23
The FDA has already undertaken many innovative and successful initiatives
to address its workforce goals. The agency's employees can take
advantage of flexible work schedules, including an "any-80" program
that can fit the difficult schedules of two working parents, care
for sick kids and elderly parents, and other outside commitments.
About one-fifth of FDA employees take advantage of the agency's
flexi-placing program, which permits telecommuting. The FDA supports
employees with childcare, elder care, and other distinctive needs.
In a recent survey conducted by OPM to gauge how federal employees
feel about their jobs, the FDA did very well compared to other government
agencies and the private sector, especially in how its employees
feel that their individual work here relates to the agency's core
mission. About 73 percent said that they found the FDA a friendly
place to work, 82 percent said their supervisor supports their need
to balance work and family issues, and 65 percent said they would
recommend the FDA as a place to work. The agency is doing well,
and it wants to do better.
Highlights for Objective 1
- Accelerate the hiring decision-making process by using specialized computer software
- Use partnerships to help the FDA acquire needed competencies
- Involve current FDA employees in recruiting from colleges and universities with large minority populations
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But FDA employees develop skills that are in great demand in the
private sector. In addition, more than 30 percent of the agency's
workforce will be eligible for retirement in less than five years.
So the FDA is working to develop succession plans and career development
plans. The agency is expanding career options, such as new fellowships
and part-time appointments at its devices center, to support combining
work at the FDA with work in an academic job. Specifically, the
FDA is committed to creating a working environment and culture in
which its product review officers have the opportunity for professional
training, and in which review responsibilities are balanced with
professional development.
To foster the development of a new generation of leaders, the agency
will increase its participation in existing formal and informal
training programs such as the HHS Emerging Leaders program and FDA
internship and mentoring programs. The agency will also develop
better programs for career progression and identify targeted career
tracks tailored for reviewers, compliance officers, investigators
and administrative staff.
Fair competition can save taxpayers an average
of 30 percent, whether the work is ultimately done in-house
or by outsiders.
OMB Director Mitchell
E. Daniels, Jr.,
May
29, 2003
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Objective 2. Increase efficiency and effectiveness of agency management.
To maintain and strengthen its position as a premier public
health agency, the FDA will modernize and update many of its
administrative support services and ensure the accountability
of its administrative support programs to support the needs
of agency staff.
To accomplish these goals, the agency will adopt new management
practices, such as:
- consolidating the delivery of administrative services using
internal performance contracts, reviewing commercial jobs
inside the agency (Full Time Equivalents or FTEs) to find
those amenable for outsourcing (the FDA plans to review more
than one third of its eligible workforce for possible outsourcing
by FY 2006)
- improving information technology capabilities to boost
productivity
- enhancing the agency's financial management to provide tighter control of revenues and expenditures
- integrating performance and budget information to support smarter resource decisions.
Highlights for Objective 2
-
Reduce administrative positions
in FDA Centers by 7.5 percent by 2004
-
Through "Shared Services" implementation,
the FDA will be able to meet its FY 2004 administrative
reduction identified in the President's budget.
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The FDA intends to implement all of these changes with careful
attention to the needs of the agency's staff and plans to implement
methods for measuring how it is performing in achieving these
goals.
Objective 3. Ensure effective communication and working relationships with key external stakeholders to enhance U.S. and global health outcomes.
The FDA is working hard to reduce risks to public health from diseases,
and from the products to help people avoid diseases and their complications.
But the FDA cannot ensure that the public gets the maximum health
benefits with minimum risks by working alone. The agency relies
upon a national and global network of health, regulatory, and science
partners, as well as industry representatives and other stakeholders.
The FDA is committed to providing accurate, science-based information
on the risks and benefits of the products it regulates to all those
who use them, and to gathering information from all those who will
help the agency ensure that FDA-regulated products are safely used.
The FDA must communicate information about these risks in an accurate
and timely manner. And the agency must have productive relationships
with its partners to plan, implement and evaluate its risk management
strategies. In addition, effective communication about FDA regulatory
and enforcement policies can help make sure that regulated firms
are doing all they can to protect and advance the health of the
public.
By working closely with partners in risk management, the FDA's
ability to closely manage the risk associated with the products
the FDA regulates is greatly improved. The FDA's stakeholder communities
are many and varied, and collaborating with all of them creates
the best opportunities for ensuring good health outcomes.
"IT has contributed 40 percent of the increase in private-sector
productivity growth, but ... has not produced measurable
gains in public-sector worker productivity."
Management
Agenda 2002
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Objective 4. Transition Information technology from an enabler to a strategic tool for realizing the FDA's policy goals and objectives.
Currently, the FDA views information technology (IT) resources as a means for the agency's medical review staff to accomplish their day-to-day work. Information technologies help staff manage the volumes of information that the agency receives more efficiently, by minimizing storage and administrative overhead, for example.
In the future, the FDA is going to view IT as a strategic tool that can be used by program staff to accomplish their policy goals and objectives with greater efficiency and effectiveness. One key action item for the FDA is the development of an integrated IT process for determining and managing Center-unique systems, FDA-wide systems, and HHS-wide systems.
The FDA's blueprint calls for an IT capability that contributes directly to mission-critical goals, such as faster review of new drugs and medical devices, more rapid targeting of suspect imports, and quicker identification, analysis, and communication of medical errors and suspected problems with the use of new medical technologies.
Objective 5. Provide a consolidated FDA headquarters campus to improve operations for employees.
The FDA is cooperating with the General Services Administration
(GSA) to consolidate the agency's diverse headquarters components,
now housed in over 40 different buildings all around the greater
Washington, D.C., area, to a new campus at White Oak in Montgomery
County, Md. This consolidation was initiated through the FDA Revitalization
Act of 1990, and the FDA is now making it a reality. The new White
Oak campus will begin housing employees in the coming year, and
will house 1,700 FDA staff by 2005.
There are four additional projects moving forward simultaneously
at the White Oak campus, which together will eventually house a
total of over 7,000 FDA employees in modern office and lab space.
The first FDA employees will be arriving at White Oak this fall.
The consolidation of FDA headquarters from 16 locations to three
will offer many benefits:
- Support effective collaboration and coordination of the agency's growing and diverse expertise in the face of increasingly complex public health challenges
- Provide greater access to the public, as well as better security for agency personnel
- Improve the efficiency of agency operations substantially through: 1) standardized, modernized, and centralized document handling, 2) greater use of shared facilities such as libraries and conference areas, and 3) elimination of redundancies in a wide range of administrative management tasks
- Reduce management layers
- Provide more of a "critical mass" for the agency's ability to develop and conduct scientific activities, including analyses for efficient risk management and translational and regulatory research, to improve the scientific foundations and efficiency of the FDA's regulatory activities.
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Footnote 23GAO Report 01-958 Sept
2002, p. 18.
Complete FDA Strategic
Plan
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