Infectious Diseases Research and Development Act of 2005

Bill: 109-hr-3154
Sponsor: Rep. Cubin, Barbara [R-WY-At Large]
Introduced: 2005-06-30 in the House
Policy area: Health
Subjects: Administrative procedure
Administrative remedies
Antibiotics
Authorization
Bacterial diseases
Building construction
Capital investments
Clinical trials
Commerce
Communicable diseases
Congress
Congressional reporting requirements
Department of Health and Human Services
District courts
Drug approvals
Drug industry
Drug resistance in microorganisms
Economics and Public Finance
Epidemics
Federal advisory bodies
Federal aid to research
Finance and Financial Sector
Food and Drug Administration (FDA)
Government Operations and Politics
Government paperwork
Income tax
Influenza
Intellectual property
Inventions
Investment tax credit
Jurisdiction
Laboratories
Law
Lung diseases
Medical supplies
Medical technology
Medical tests
Patents
Pharmaceutical research
Product development
Products liability
Punitive damages
Research and development
Research and development facilities
Research grants
Science, Technology, Communications
Small business
Standards
Subsidies
Tax credits
Tax deductions
Taxation
Vaccines
Virus diseases

Summary:
action_date: 2005-06-30
text: 
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.


Legislative actions:
action_date: 2005-07-29
text: Referred to the Subcommittee on Health.
action_date: 2005-06-30
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-06-30
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-06-30
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-06-30
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-06-30
text: Introduced in House
action_date: 2005-06-30
text: Introduced in House