Good morning, my name is Sharon Smith Holston, and I am the Deputy
Commissioner for External Affairs of the Food and Drug Administration (FDA).
Thank you for the opportunity to appear before the Subcommittee to discuss the
Agency's headquarters consolidation project.
The consolidation project for the Food and Drug Administration. (FDA) was
authorized by Public Law 101-635, the FDA Revitalization Act of 1990. This
initiative, which received strong bipartisan support, directed the Secretary of
Health and Human Services, and the Administrator of the General Services
Administration (GSA), to take appropriate action to consolidate FDA's
headquarters components in modern office and laboratory facilities.
In 1994, the Office of Management and Budget approved a consolidation plan
for the headquarters programs of the FDA, estimated to cost $890 million, which
was to provide the Agency with a total of 3.6 million gross square feet of
laboratory, office, and support space. This plan called for the office of the
Commissioner, the Office of Regulatory Affairs (which oversees FDA field
programs), the Center for Drug Evaluation and Research (CDER), the Center for
Biologics Evaluation and Research (CBER), and the Center for Devices and
Radiological Health (CDRH), to be located in Montgomery County, Maryland. The
Center for Food Safety and Applied Nutrition (CFSAN) and the Center for
Veterinary Medicine (CVM) would be located in Prince George's County, Maryland,
reflecting their similar food safety mission.
Congress had already appropriated nearly $319 million for the project and
GSA augmented these funds by internally reprogramming about $6 million, creating
a total of $325 million in available project funds. of this amount, $49 million
has been obligated for the construction of Module II in Beltsville, Maryland.
In 1995, however, Congress voted to rescind $228 million of the funding
which had been allocated for FDA facilities in Montgomery County, Maryland.
This rescission of funds left only $48 million for the entire consolidation
project. Of this amount, $14 million was set aside for site studies and design
of facilities in Montgomery County, with no money for construction there; $5
million for establishment of the Seafood Research Center at the Columbus Center
in Baltimore, Maryland, which was dedicated in February; and $29 million for
land acquisition and building design in Prince George's County, Maryland.
In rescinding the $228 million, Congress sent a signal to GSA and FDA to
reduce the scope of the project as well as its land requirements. GSA
authorized the design firm of TKLP to restudy the FDA project. This resulted in
a reduction in overall gross area to 2.5 million square feet and a reduction in
acreage in Montgomery County, Maryland to 130 acres.
When the Base Realignment and Closure Commission decided in mid- 1995 to
close the Naval Surface Warfare Center at White Oak, that location became the
prime candidate site for the FDA project, and GSA is proceeding with a no-cost
acquisition of the property. We understand that GSA has requested $3 million in
Fiscal Year 1997 funds for remediation of hazardous materials at the White Oak
site, and we fully support that request.
The $29 million that was left by Congress for the FDA project in Prince
Georges County, Maryland, was augmented later in 1995 by an appropriation of an
additional $55 million for FY 1996, resulting in the availability of $84 million
for land acquisition, design, and construction of new laboratory and office
facilities for our foods center, and new offices for our veterinary medicine
center. In response to Congressional interest and the stated preference of the
new Prince George's County Executive regarding the siting of the new foods and
veterinary medicine facilities, GSA and FDA evaluated potential building sites
near the Greenbelt and College Park Metro stations. Since FDA and the
University of Maryland recently negotiated a collaborative agreement in food
safety and nutrition research, it was logical that GSA chose for the new
facility a site close to the College Park Metro station. We expect site
acquisition and ground breaking to occur this Fall.
Mr. Chairman, at present, FDA is scattered in more than 40 buildings -- many
with outdated and unacceptable laboratories -in 18 different locations. This
makes it difficult for us to serve the public in an efficient, cost-effective
manner, and also makes it difficult for us to recruit outstanding scientific
talent for the important work we do. Through this consolidation project we will
be able to improve our laboratories and consolidate in three locations in the
Washington area, which will give us the necessary state-of-the-art laboratories
and other modern facilities and conditions in which we can maximize FDA's
effectiveness well into the next century.
Mr. Chairman, this consolidation project is important for our continued
ability to perform the many public health missions that Congress and the
American people want us to carry out. American consumers have come to expect
and rely on the safety and wholesomeness of our food supply and the high
standards of safety and effectiveness of our drugs and medical devices. The
rigorous demand for safety and efficacy that makes FDA approval the
international gold standard is not only in the best interest of American
consumers and American patients, but also American industry -- particularly when
trying to market products abroad. We are committed to maintaining those
standards and meeting those expectations.
This is our core function. FDA's activities cover more than $1 trillion
worth of products, many of which are vital for human health. Our diverse
responsibilities include licensing blood banks; monitoring clinical
investigations; reviewing and approving prescription drugs, generic drugs,
animal drugs, vaccines, biologics, medical devices and food additives; and
post-market surveillance and enforcement activities.
Mr. Chairman, the scientific work we do in our laboratories provides
critical support for our regulatory mission across the entire range of FDA
program activities. However, our ability to do this job, with the best science
and highly skilled personnel, is being threatened by our outdated and
inefficient, leased facilities which were never designed to handle today's
advanced laboratory functions.
As a regulatory Agency, we do research to answer the questions that allow us
to determine what has to be done to protect public health. For example, the FDA
needs food-related research laboratories in order to maintain critical expertise
for emergency response, to conduct unique research for emerging food safety
areas, and to provide quality assurance and maintain uniformity in laboratory
operations conducted in the Agency's field laboratories and other laboratories
world-wide under mutual recognition stipulations of international trade
agreements. The Agency must maintain critical expertise in such food-related
areas as chemistry, microbiology, toxicology, nutrition, food technology, and
bio-technology. For example, the Agency relies on its food chemistry
laboratories for development of methods for detecting and quantifying the levels
of pesticides; heavy metals such as lead and mercury; industrial chemicals such
as polychlorinated dioxins (PCDD's); natural toxins such as aflatoxins and
fumonisins; and contaminants and constituents associated with packaging, colors,
and food additives. Without FDA, such scientific research might never be
Regarding pharmaceuticals, the FDA performs research to determine the risks
and benefits of pharmaceutical agents and to set appropriate standards and
methods for analysis. These activities include research on specific products
or product classes that are approved or under review. Research is carried out
in biomedical areas to develop expertise necessary to address new technologies
and issues, gain expertise in emerging areas, develop and validate testing
methodologies, and to establish drug and biologic standards. All of these
activities are fundamental to the evaluation of human drugs and biological
And yet, studies dating back 20 years document the serious inadequacies of
our headquarters laboratory facilities. A 1976 FDA study found that the
condition of laboratories at five of nine locations were "unacceptable", two
were "marginal", and only two were "generally suitable", with some marginal
deficiencies. Many of these conditions still exist today. The Agency has been
able to address some of the most serious problems; however facility deficiencies
A 1989 General Accounting Office (GAO) report documented serious problems
with electrical, heating, cooling, and waste disposal systems in FDA
A GSA-contracted study of-FDA's facilities needs, funded with $1.2 million
appropriated by Congress in Fiscal Year 1990, confirmed the inadequacy and the
inefficiency of FDA's existing office and laboratory facilities. As part of
that study, GSA surveyed headquarters laboratory facilities and found that many
of them needed replacement.
Since the findings were made, we have been able to make some improvements in
some of our laboratories. For instance, we have opened new laboratories and
office space for our Center for Biologics Evaluation and Research (CBER) on the
campus of the National Institutes for Health. The Center for Veterinary
Medicine (CVM) Research Center (Module II) in Beltsville, Maryland, is currently
under construction and occupancy is expected in the Fall of 1996. We appreciate
the appropriations that have made those improvements possible. But problems
similar to those found in the GAO and GSA surveys continue.
Moreover, the geographic fragmentation of our building sites has grown worse
over the past decade. In 1987, FDA was located in 25 buildings at eight sites.
Today, we are housed in more than 40 buildings at 18 sites. The Office of the
commissioner and each of the five Centers are located at different sites. In
addition, each Center has activities located in different places.
The separation of FDA's five Washington-based Centers in different locations
also adversely effects efficiency. our experience demonstrates that the Agency
is increasingly required to resolve policy questions involving multiple FDA
Centers, differing or overlapping statutory jurisdiction, or complex emerging
developments in new science or technology that affect more than one of our
Centers. This emerging trend means that there is a greater need for
collaboration across Center lines, and for sharing resources, including
personnel, equipment, and scientific expertise. A consolidated FDA headquarters
facility will allow the Agency to respond to this crucial need more efficiently.
Similarly, the Agency is receiving an increasing number of applications for
combination products. These products, which are a combination of a drug and
device, or both a drug and a biologic, require review by more than one Center.
Examples of combination products include drug delivery systems, medicated wound
dressing, bone cement containing an antibiotic, and dental composites with
Consolidation will allow FDA scientists to engage in collaborative efforts
that are critical both to the advancement of knowledge and to the coordination
of research and review functions performed by the Agency. Research and review
scientists should be able to share their expertise and bring the best possible
scientific intelligence to bear on critical product approval and public health
decisions. Moreover, when our scientists can work together, they can increase
the speed of our product approval decisions, which is one of our highest
priorities. we anticipate that the consolidation will enable us to continue
improving the time frames for product approval decisions.
In addition to helping us help the public, the FDA consolidation project
makes good economic sense. It will give American taxpayers a solid return on
their investment. The GSA has established the cost effectiveness of this
project; we at FDA also believe that there would be other cost savings resulting
from consolidation, including improved working efficiencies and productivity,
better utilization of existing laboratory equipment, and reduction in travel
GSA and FDA are committed to completing the headquarters consolidation
project with a cost effective, functional and flexible design that will serve
the mission of the Agency far into the next century.
Mr. Chairman, the American public expects FDA to continue to ensure the
safety and efficacy of food and drugs on the market. It is absolutely essential
that our antiquated laboratories be replaced if we are to keep pace with
emerging technologies and the industries we regulate, and ensure the health and
safety of American citizens. I urge your continued support for our