IV 111th CONGRESS 2d Session H. RES. 1179 IN THE HOUSE OF REPRESENTATIVES March 12, 2010 Mr. Davis of Illinois submitted the following resolution; which was referred to the Committee on Energy and Commerce RESOLUTION Expressing the sense of the House of Representatives that biotechnology firms meeting small business standards are critical to the United States, its people and its economy because they create new medicines, services, and jobs and meet unmet needs related to populations and patients with infectious and chronic diseases, including those of medically underserved populations.

Whereas small biotechnology firms have developed intellectual property that is of value to the health and well-being of the people in the United States and the world; Whereas small biotechnology firms deserve a comprehensive, prompt, direct, and effective review of their products and processes by all Federal agencies of jurisdiction; Whereas HIV/AIDS, the most virulent strains of tuberculosis, Hepatitis C, pandemic diseases, and other life threatening conditions, including cardiovascular conditions, stroke, cancer, sickle cell, neurological conditions, gastrointestinal, infectious, autoimmune, and mental illness diseases, are an increasing threat to the life, safety, and the fiscal balance of State and local health public health organizations, especially in areas with high proportions of underserved and under-resourced populations; Whereas over 1,100,000 persons in the United States are living with HIV/AIDS, including a large number of racial and ethnic minorities; Whereas there is a need to encourage therapies and new drug development to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases, including those in medically underserved communities; Whereas new antibiotic and biologic medicines for these infections and diseases will not only save lives, but provide cost savings vitally important to the improvement of the Nation’s health and the reduction of health care costs; and Whereas small business biotechnology firms need Federal assistance to commercialize products related to new and promising technologies, including therapeutics for drug resistant pathogens, new approaches to antibiotics based on defensin mimetics, adenosine-based synthetic blood substitutes, allogeneic cellular immune therapy, peptide-based and nanoparticle-based therapeutic HIV vaccines, HIV vaccine adjuvants, immune-based therapies including irreversible pepsin fraction, cytokines, and hormones, innovative clinical interventions for adverse, debilitating drug related events such as peripheral neuropathy, HIV antiviral therapies, and processes including lentiviral-based gene therapy, antiviral hyperactivation limiting therapeutics, autologous dendritic cell therapy, Pyrimidinedione-based NNRTIs, dual tropic CCR5 antagonists, point-of-care rapid diagnostics, and therapeutic nutrition: Now, therefore, be it

That the House of Representatives— (1)recognizes that the public deserves the safest, most effective, and efficient processes in regards to saving the lives of people living in the United States with infectious and chronic diseases; (2)supports the domestic development and commercialization of biotechnology research by firms meeting small business size standards and collaborations with university-based biotechnology research facilities; (3)supports and seeks to encourage the advancement of United States-based commercialization of point of care therapeutics and diagnostics by emerging and small business biotechnology firms for domestic and global use; (4)recognizes the need to coordinate existing public funding to help small business biotechnology firms whose products may be lost due to domestic economic conditions, and fund critical paths for small biotechnology drug development and for regulatory review and commercial approval; (5)encourages the development of a formalized, national strategic framework to facilitate technological advancements in improving the commercialization processes for small business biotechnology firms; (6)wishes to promote and encourage the creation of incentives for small business biotechnology companies that perform basic and applied research through the development and commercialization of biotechnology products and processes and their diffusion into national and local economies to improve the quality of life of people in the United States; (7)encourages the development of a comprehensive approach to describing disease populations and the production of comprehensive research programs that are current with evolving biotechnology and the unmet needs of diverse patient populations; and (8)encourages the Office of the Secretary of the Department of Health and Human Services to develop a Federal Biotechnology Coordinating Council representative of small business biotechnology companies, research facilities, and Federal agencies with a strategic initiative to facilitate development and preserve these small business biotechnology firms and coordinate resources and funding mechanisms for this purpose.