H.R.3154 - Infectious Diseases Research and Development Act of 2005

To provide incentives for pharmaceutical companies, biotechnology companies, and medical device companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent an infectious disease, and for other purposes. view all titles (2)

All Bill Titles

  • Short: Infectious Diseases Research and Development Act of 2005 as introduced.
  • Official: To provide incentives for pharmaceutical companies, biotechnology companies, and medical device companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent an infectious disease, and for other purposes. as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
06/30/05
 
 
 
 
 
 
 

Official 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 unnecessar

Official 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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