Infectious Diseases Research and Development Act of 2005

Summary

Infectious Diseases Research and Development Act of 2005 - Limits the liability of manufacturers of qualified infectious disease products by limiting: (1) punitive damages unless the manufacturer acted with malicious intent to injure the individual or deliberately failed to avoid unnecessary injury that the manufacturer knew the individual was substantially certain to suffer; and (2) non-economic damages to $250,000. Sets forth circumstances under which the term of a patent may be extended for qualified infectious disease products. Requires the Secretary of Health and Human Services to designate qualified infectious disease products as fast-track products for approval. Amends the Public Health Service Act to require the Director of the National Institute of Allergy and Infectious Diseases to expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products. Amends the Internal Revenue Code to establish an infectious disease research credit and a qualified infectious disease products manufacturing facilities investment credit. Authorizes appropriations for activities related to antimicrobial resistance. Establishes the Commission on Infectious Diseases Product Development to identify infectious pathogens that are a significant threat to public health and make recommendations to the Secretary on how best to address such pathogens. Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary, acting through the Commissioner of Food and Drugs, to issue guidelines for the conduct of clinical trials with respect to antibiotic drugs.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 30 June 2005

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• Introduced in House (PDF)

  Introduced in House · EN · 30 June 2005

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• Introduced in House

  summary · EN · 30 June 2005

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