STATEMENT BY

SHARON S. HOLSTON.

DEPUTY COMMISSIONER FOR EXTERNAL AFFAIRS

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SUBCOMMITTEE ON PUBLIC BUILDINGS

AND ECONOMIC DEVELOPMENT

COMMITTEE ON TRANSPORTATION AND INFRASTRUCTURE

HOUSE OF REPRESENTATIVES

MAY 23, 1996

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 Georges 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 Georges 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 Georges 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 postmarket 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 biotechnology. 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 undertaken.

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 products.

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 still remain.

A 1989 General Accounting Office (GAO) report documented serious problems with electrical, heating, cooling, and waste disposal systems in FDA laboratories.

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 fluoride.

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 costs.

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 consolidation plan.

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