[Congressional Record (Bound Edition), Volume 149 (2003), Part 20]
[Senate]
[Page 28142]
[From the U.S. Government Publishing Office, www.gpo.gov]




                  FDA CBER RESEARCH ACTIVITIES FUNDING

  Mr. BENNETT. Mr. President, the fiscal year 2004 Agriculture, Rural 
Development and Related Agencies Appropriations Act includes 
appropriations for the Center for Biologics Evaluation and Review of 
the Food and Drug Administration to continue important vaccine and 
biological product research activities. Support of these research 
activities is essential for keeping CBER scientists and medical 
reviewers up-to-date and knowledgeable of the breakthrough science of 
vaccine and biological product research and development. Being involved 
in this cutting edge research better equips CBER scientists and 
reviewers with the best scientific-based tools for reviewing and 
regulating the safety and efficacy of live-saving vaccines and other 
biological products.
  During our subcommittee and Committee deliberations, many colleagues 
shared my concerns about the emergence of SARS, West Nile Virus, monkey 
pox, antibiotic resistant staphylococcal infections in hospitals, and 
other naturally-occurring infectious diseases in the U.S. I believe 
there is a need to expedite the development and licensing of new 
vaccines and biologicals to protect our citizens from these naturally-
occurring infectious diseases. As with recent efforts and increased 
appropriations to augment research, regulatory testing and scientific 
capabilities of the FDA to assist in combating bioterrorism threats, I 
endorse FDA's continued support of those capabilities at the Center for 
Biologics Evaluation and Research to combat the public health threats 
from naturally-occurring diseases. It is my view that continued support 
of these capabilities will better enable the Center to recruit and 
retain highly-qualified, motivated scientists and medical reviewers for 
vaccines and other biological products.
  In past years, CBER scientists engaged in laboratory and clinical 
research, which greatly improved their understanding of the science, 
their mission of assuring the safety and efficacy of the products under 
review by FDA, the medical needs of patients, and alternative products 
available. This understanding resulted in a more efficient and rapid 
agency licensing processes for many new products, which presented 
complex scientific, medical and public health issues. For example, CBER 
reviewers deeply involved in relevant laboratory research were 
responsible for the complex yet expeditious regulatory review and 
licensing of the four combination diphtheria-tetanus-acellular 
pertussis (DTaP) vaccines and the four Hib (meningitis) conjugate 
vaccines during the last decade.
  Past CBER research has significantly contributed to technology 
transfer and benefited the public through the development of assays and 
reagents, which would otherwise be too costly and time-intensive for 
industry to duplicate. This research has facilitated the expedited 
testing, development, and availability of several important licensed 
vaccines for the prevention of life-threatening pediatric diseases and 
is critical for others currently under development for licensing in the 
future.
  Mr. President, I urge the Administration to provide sufficient 
funding in fiscal year 2005 for continued CBER research. These 
appropriations are essential for expediting not only the development 
and availability of licensed counter-bioterrorism vaccines and 
biological products, but also for those intended for the prevention and 
treatment of naturally-occurring infectious diseases, such as SARS, 
West Nile Virus and HIV-AIDS.

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