A bill to ensure the prompt research, development, manufacture, and distribution of new life-saving drugs, biologics, and medical devices that prevent or mitigate the consequences of a chemical or biological bioterrorist attack, and for other purposes.
Authorizes the Secretary to enter into contracts and provide assistance for product development, including good manufacturing practices and facility security.
Requires the Secretary to ensure that medical supplies from the National Pharmaceutical Stockpile are located in appropriate proximity to the site of special events.
Amends the Federal Food, Drug, and Cosmetic Act to permit: (1) fast-track designation and priority review for unapproved countermeasure products; and (2) the use of animal trials for drugs useful against lethal or disabling agents.
Requires the Secretary to: (1) prohibit the unauthorized transportation of chemical or biological agents; (2) establish and maintain a list of each biological agent and toxin potentially threatening to public health and another list of those agents and toxins potentially threatening to national security; and (3) establish safety procedures for the transfer of such agents and toxins.
Requires the Secretaries of Health and Human Services and Defense to coordinate the creation of a government-owned, contractor-operated vaccine production facility on a military installation.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S11489-11491)
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