Similar to last year, the Bush administration's early February budget proposal for fiscal year (FY) 2004 focuses considerable attention on bioterrorism countermeasures. Many of the countermeasures are bundled into the 10-year, $6 billion BioShield initiative that was announced days earlier during the president's State of the Union address. The budget calls for an overall federal investment of $123 billion in research and development (R&D), up by 7% from last year, with $27 billion of that for basic research across the sciences.
Embedded in the BioShield proposal is a call for new “emergency use authorization” to the Food and Drug Administration (FDA; Rockville, MD). This authority will permit use of emerging treatments, even if not yet proved suitable for routine general use or formally approved by the FDA. Other new authorities sought under the BioShield proposal will allow officials at the National Institutes of Health (NIH; Bethesda, MD) “to hire the best experts, make special purchases, and face other management challenges that can be barriers to quick progress in converting basic scientific discoveries into usable products.”
The FY 2004 budget and BioShield proposals also seek authority for the new Department of Homeland Security (Washington, DC) to purchase vaccines and medicines for the national stockpile, while allotting $900 million for that purpose. This program will “serve to assure potential manufacturers that if they can create a safe and effective product needed to counter bioterrorism threats, the government can purchase it,” thus providing the private sector with a guaranteed client for products with otherwise uncertain marketability. Meanwhile, the Department of Defense budget includes $1.1 billion for its chemical and biological defense program, with a $200 million increase to extend protection to 200 installations, increase Army biological detection capabilities, and combat new chemical agent threats.
Many additional bioterrorism countermeasures or other biotechnology-related programs fall within NIH, whose proposed overall budget is $27.9 billion, a small increase of $550 million over the previous year. The NIH FY 2004 budget request specifies $1.6 billion for bioterrorism-related research programs, including new strategies for blocking effects of the botulism toxin, expanded research on immune system cells, and accelerated testing of therapeutics, vaccines, and diagnostics geared to potential agents of bioterrorism.
Also of interest, the NIH FY 2004 budget request for the Office of the Director includes an increase of $35 million for several strategic “roadmap” initiatives, including new pathways to develop a comprehensive understanding of the building blocks of the body's cells and tissues and how complex biological systems operate, regenerative medicine, structural biology, molecular libraries, nanotechnology, computational biology and bioinformatics, and molecular imaging. Efforts under these initiatives aim at translating “findings from genetics and proteomics into front-line treatments and prevention strategies.”
Other parts of these Department of Health and Human Services (HHS; Washington, DC) bioterrorism preparedness programs come under the Centers for Disease Control and Prevention (Atlanta, GA), whose budgeted $1.1 billion covers expanded planning efforts, oversight of transfers of pathogens and toxins between laboratories, lab safety inspections, and anthrax research. Elsewhere in HHS, the administration is seeking strengthened authority over food imports, a duty that is shared among officials at the FDA and the US Department of Agriculture (USDA; Washington, DC). As part of this proposal to enhance food safety, FDA will be seeking to register food manufacturing and processing facilities inside and outside the US.
The overall request from the administration for the FDA is about $1.7 billion, which is very close to the FY 2003 level and depends on $307 million in user fees. Some $249 million represents fees collected under the Prescription Drug User Fee Act, with another $29 million collected under newer authority as Medical Device User Fees. In addition, the administration proposes collecting user fees for veterinary drugs. The overall FDA budget specifies $176 million, a modest increase of $18 million, for efforts to protect against bioterrorist threats.
The FDA budget request also specifies an increase of $13 million for reviewing and ensuring the safety of generic drugs, noting that their rapid review is “essential to maximize the availability of high quality, lower cost prescription drugs.” Agency officials also plan “targeted research ...to establish more standards of bioequivalence, and [to] broaden the types of drugs for which generics are available.”
Federal research programs in other departments and agencies also impinge on biotechnology. For instance, the administration proposes a $5.48 billion budget for the National Science Foundation (NSF; Arlington, VA), a 9% increase over the previous year; overall, $562 million is designated for biology. Agency officials highlight the NSF “Biocomplexity in the Environment” program, which is slated for $99.83 million and supports research on molecular structures, genes, organisms, and ecosystems; it features programs to sequence the genomes of microorganisms of importance to agriculture, food, forestry, and water quality, or as potential bioterrorism threats. Another program requests $31.7 million to support plant genome “virtual” centers, whose investigators focus on genomes of economically important plant species.
The $74 billion USDA budget includes $1.034 billion for the Agricultural Research Service (ARS), a small decrease from the preceding year. ARS research addresses a wide range of crop and animal production issues, including pest and disease management through use of biologically based technologies, plant and animal genome mapping, and the maintenance and improvement of plant germplasm. The budget request includes a proposed $3.5 million increase for plant genomics, a similar $3.5 million increase for animal genomics, an increase of $8.3 million for research on emerging diseases, and nearly $47 million to strengthen laboratory security measures.
The USDA budget also would provide $200 million for the USDA National Research Initiative, a competitive grants program that covers a broad spectrum of research efforts, including biotechnology; and $252 million for its Forest Service Research and Development programs, $2 million of which is for “biobased products.” Elsewhere in the USDA, the Animal Plant Health Inspection Service is to receive a $30 million increase for inspection services, expanding the availability of foot-and-mouth disease vaccines, providing protection against chronic wasting disease and poultry diseases, and expanding diagnostic and other technical services.
The FY 2004 life sciences budget within the Department of Energy (Germantown, MD), calls for $201 million, an increase of about 5.5%, to support genomics, bioremediation, and other biotechnology-related research programs. Meanwhile, the Advanced Technology Program within the Commerce Department's National Institute of Standards and Technology (Gaithersburg, MD), is facing a sharp decrease to $27 million for administrative costs to end this program, which has supported cooperative research ventures between companies, including those doing biotechnology, and universities.
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Fox, J. US budget/Bioshield initiative emphasizes bioterrorism countermeasures. Nat Biotechnol 21, 216 (2003). https://doi.org/10.1038/nbt0303-216
Nature Biotechnology (2004)