Biodefense and Pandemic Vaccine and Drug Development Act of 2005

Summary

Biodefense and Pandemic Vaccine and Drug Development Act of 2005 - Amends the Public Health Service Act to establish the Biomedical Advanced Research and Development Agency (BARDA) within the Department of Health and Human Services (HHS) to coordinate and oversee activities that support and accelerate qualified countermeasure or qualified pandemic or epidemic product advanced research and development. Requires the Director of BARDA to establish and convene a Vulnerable Populations Working Group. Establishes the National Biodefense Advisory Board and the Biodefense Medical Countermeasure Development Fund. Amends the Federal Food, Drug, and Cosmetic Act to extend the period of market exclusivity for designated countermeasure products from seven to ten years. Prohibits any cause of action for liability for damages related to a security countermeasure or a qualified pandemic and epidemic product, with an exception for willful misconduct. Requires the Secretary of HHS to establish a process to provide compensation to individuals involved in an emergency response plan who are injured as a result of a countermeasure. Allows the Secretary to award rebates or grants related to manufacturing of, or research on, vaccine, qualified countermeasures, or qualified pandemic or epidemic products. Requires the Secretary to establish the Animal Model/Research Tool Scientific Advisory Committee. Amends the Clayton Act to allow antitrust exemptions for certain meetings and agreements among parties involved in the development of security or qualified countermeasures or qualified pandemic or epidemic products if deemed necessary to ensure the availability of such countermeasures or products. Prohibits any payment on a security countermeasure procurement contract until delivery of a acceptable portion of such product to the Secretary unless advance payment is necessary to ensure the success of the project. Establishes the National Pathology Center and a Board of Regents of the Center. Transfers to the Center certain functions of the Armed Forces Institute of Pathology.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 24 October 2005

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• Reported to Senate (PDF)

  Reported to Senate · EN · 24 October 2005

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• Reported to Senate with amendment(s)

  summary · EN · 24 October 2005

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• Introduced in Senate (text)

  Introduced in Senate · EN · 17 October 2005

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 17 October 2005

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• Introduced in Senate

  summary · EN · 17 October 2005

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