U'S' Department of Health

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U.S. Department of Health Human
ServicesProject BioShield
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Project BioShield

• Bioterrorism is a clear and present danger.
• The development and availability of effective
  countermeasures against agents of bioterror are
  essential to protect the homeland.
• It is critical to expedite and accelerate the
  development of effective countermeasures.

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Project BioShield

• Purpose
• To accelerate the process of research,
  development, purchase, and availability of
  effective countermeasures against agents of
  bioterror.

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Project BioShield

• Three-pronged program
• Establish secure funding source for purchase of
  critical biomedical countermeasures.
• Increase authorities and flexibility for NIH /
  NIAID to expedite research and development of
  critical biomedical countermeasures.
• Establish a FDA Emergency Use Authorization for
  critical biomedical countermeasures.

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Project BioShield

• Establish secure funding source for purchase of
  critical biomedical countermeasures.
• Permanent and Indefinite Appropriations to DHS.
• Current projection is 5.6 billion over 10 years
  for smallpox, anthrax and botulinum
  countermeasures.
• Funding would be available for other
  countermeasures once production of licensable
  products is judged scientifically feasible.
• Appropriation can only be used when the President
  has approved a joint request from HDS and HHS
  Secretaries.
• HHS is the procuring authority.
• Appropriation can only be used to purchase
  countermeasures for which there is no significant
  commercial market other than homeland security.

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Project BioShield

• Increase authorities and flexibility for NIH /
  NIAID to expedite research and development of
  critical biomedical countermeasures.
• Streamline procurement authority.
• Expedite review of grants, contracts and
  cooperative agreements.
• Bolster authorities for acquisition,
  construction, and renovation of facilities.
• Expedite professional and personal services
  contracts.
• Provide flexibility with regard to personnel
  authority.

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Project BioShield

• Establish a FDA Emergency Use Authorization for
  critical biomedical countermeasures.
• Based on a threat determination by the DHS
  Secretary, DOD Secretary or the HHS Secretary,
  the HHS Secretary can issue an order allowing an
  unapproved drug or biologic to be used in an
  emergency.
• HHS Secretary must find that there is reason to
  believe that the product is effective, that the
  benefits outweigh the risks, and that there is no
  adequate alternative.
• This new authority could be used to facilitate
  the use of the Aventis-Pasteur smallpox vaccine
  in an emergency.
• HHS Secretary can impose certain conditions
  (e.g., who may administer and to whom, consent
  requirements, labeling and record keeping).