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Vaccine Policy

Project Bioshield In his 2003 State of the Union Address, President Bush announced Project BioShield -- a comprehensive effort to develop and make available modern, effective drugs and vaccines to protect against attack by biological and chemical weapons or other dangerous pathogens. Project BioShield will:

  • Ensure that resources are available to pay for "next-generation" medical countermeasures.
  • Strengthen NIH development capabilities by speeding research and development on medical countermeasures. 
  • Give FDA the ability to make promising treatments quickly available in emergency situations.

White House Statement

Transcript of President Bush's remarks at NIH, 2/3/03

Two Animal Rule

The FDA Animal Efficacy Rule (finalized May 2002) applies to development/testing of drugs/ biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal /permanently disabling toxic agent (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical.

FDA can rely on evidence from animal studies to provide substantial evidence of product effectiveness when:

  • There is a reasonably well-understood mechanism for the toxicity of the agent and its amelioration or prevention by the product;
  • The effect is demonstrated in either:
    • More than one animal species expected to react with a response predictive for humans, or;
    • One well-characterized animal species model (adequately evaluated for its responsiveness in humans) for predicting the response in humans;
  • The animal study endpoint is clearly related to the desired benefit in humans; and
  • Data or information on the pharmaco-kinetics and –dynamics of the product or other relevant data or information in animals or humans is sufficiently well understood to allow selection of an effective dose in humans, and it is therefore reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans.

For more guidance on the two animal rule see the CBER/FDA Biodefense page

HIPPA

The U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). iThe Privacy Rule standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals' privacy rights to understand and control how their health information is used. http://www.hhs.gov/ocr/privacy/index.html

Last revised: January 2, 2004

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