LEGISLATIVE UPDATE June 2007
Diseases of the Heart, Lungs, Blood, or Blood Vessels
- Comprehensive Tuberculosis Elimination Act of 2007 (H.R. 1532)
- Heart Disease Education, Analysis and Research, and
Treatment for Women Act (H.R. 1014 and S. 573)
Stem Cell Research
- Stem Cell Research Enhancement Act of 2007 (S.977)
Genetics and Genomics
- Genomics and Personalized Medicine Act of 2007 (S. 976)
- Genomic Research and Accessibility Act (H.R. 977)
Clinical Research
- Enhancing Drug Safety and Innovation Act of 2007 (H.R. 1561)
- Fair Access to Clinical Trials Act of 2007 (S. 467)
- Pediatric Medical Device Safety and Improvement Act of 2007 (H.R. 1494 and S. 830)
Health Care
- American Health Security Act of 2007 (H.R. 1200)
Animal Research
- Pet Safety and Protection Act of 2007 (H.R. 1280 and S. 714)
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Diseases of the Heart, Lungs, Blood, or Blood Vessels
Comprehensive Tuberculosis Elimination Act of 2007
Number: H.R. 1532
Sponsor: Representative Gene Green (D-TX)
Referred to: House Committee on Energy and Commerce
Highlights:
Would require the Director, NHLBI, to expand, intensify, and
coordinate research and development and related activities of
the Institute regarding tuberculosis (TB), and authorize the
Director to provide awards to faculty of schools of medicine
and osteopathic medicine for curricula development and awards
to support the career development of clinically trained
professionals committed to research on pulmonary infections and TB.
The bill would also amend Sec. 447A, Public Health Service Act, to
require the National Institute of Allergy and Infectious Diseases
to include development of a TB vaccine within its related research
activities; and would require the Fogarty International Center to
expand, intensify, and coordinate its international activities with
respect to TB research and training.
Heart Disease Education, Analysis and Research, and Treatment for Women Act
Number: S.573 and H.R. 1014
Sponsor: Senator Debbie Stabenow (D-MI) and Representative
Lois Capps (D-CA)
Referred to: Senate Committee on Health Education, Labor,
and Pensions; House Committee on Energy and Commerce
Highlights:
Would require that information reported to the FDA
for new drug applications and investigational new
drug applications be stratified by sex and ethnicity.
Would require the Secretary, HHS to report annually on
findings related to quality of and access to care for
women with cardiovascular disease. Would also require
the Secretary, HHS to develop and distribute educational
materials about prevention, diagnosis, and treatment of
cardiovascular disease to women over 65 and physicians
and other healthcare professionals.
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Stem Cell Research
Stem Cell Research Enhancement Act of 2007
Number: S. 997
Sponsor: Senator Tom Harkin (D-IA)
Highlights:
The bill is an amended version of S. 5, and would
require the Secretary of HHS to conduct and support
research using human embryonic stem cells regardless
of the date on which such cells were derived.
The bill would also require the Secretary to conduct
and support research involving methods of obtaining
pluripotent stem cells that do not involve the use
of human embryos.
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Genetics and Genomics
Genomics and Personalized Medicine Act of 2007
Number: S. 976
Sponsor: Senator Barack Obama (D-IL)
Referred to: Senate Committee on Health, Education, Labor and Pensions
Highlights:
Would require the Secretary of HHS to establish the
Genomics and Personalized Medicine Interagency Working
Group (IWG). Among other duties, the IWG would develop
guidelines for procedures, protocols, and policies
safeguarding the privacy of biobank subjects, in
accordance with the Office for Human Research
Protections and Clinical Research Policy Analysis and
Coordination Program at the NIH. S. 976 would also
authorize the Secretary to establish a national
biobanking database; a biobank initiatives grant
program; and a mechanism for management and submission
of pharmacogenomic data developed by the FDA in
collaboration with the NIH and CDC. The Secretary would
conduct studies in order to realize the potential of
personalized medicine by accelerating genomic research,
increasing understanding of how genomics interacts with
environmental factors to cause disease, and accelerating
development of accurate diagnostics and treatments.
Genomic Research and Accessibility Act
Number: H.R. 977
Sponsor: Representative Xavier Becerra (D-CA)
Referred to: House Committee on the Judiciary
Highlights:
Would amend title 35, United States Code,
to prohibit the patenting of human genetic material.
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Clinical Research
Enhancing Drug Safety and Innovation Act of 2007
Number: H.R. 1561
Sponsor: Representative Henry Waxman (D-CA)
Referred to: House Committee on Energy and Commerce
Highlights:
Would modify procedures at FDA regarding the approval of drugs.
Title III of the bill would require NIH to expand
ClinicalTrials.gov to include a broader registry of clinical
trials. The bill would also require NIH to establish a "results"
database that would require sponsors of clinical trials to submit
results of those clinical trials included in the registry,
accompanied by a narrative summary describing those results.
Fair Access to Clinical Trials Act of 2007
Number: S. 467
Sponsor: Senator Christopher Dodd (D-CT)
Referred to: Senate Committee on Health, Education, Labor and Pensions
Highlights:
Would require the expansion of ClinicalTrials.gov to
include a results database.
Pediatric Medical Device Safety and Improvement Act of 2007
Number: S. 830 and H.R. 1494
Sponsor: Senator Christopher Dodd (D-CT) and Representative
Edward Markey (D-MA)
Referred to: Senate Committee on Health, Education,
Labor and Pensions; House Committee on Energy and Commerce
Highlights:
Would require NIH, FDA, and AHRQ to develop a plan for
expanding medical device research and development.
Provisions would also require the Secretary, HHS,
to provide grants to a non-profit consortium, which would
be tasked with facilitating the development of pediatric
devices, by connecting individuals with ideas for pediatric
devices with potential manufacturers. The consortium would
be required to coordinate with NIH in these efforts and would
be responsible for notifying NIH of any unmet needs that the
consortium lacks sufficient capacity to address.
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Health Care
American Health Security Act of 2007
Number: H.R. 1200
Sponsor: Representative Jim McDermott (D-WA)
Referred to: House Committees on Energy and Commerce;
House Committee on Ways and Means; House Oversight
and Government Reform
Committee; and House Armed Services Committee
Highlights:
The purpose of the bill is "to provide for health care for
every American and to control the cost and enhance the quality
of the health care system." Of interest to NIH is section 722,
which would establish the Office of Primary Care and Prevention
Research within the Office of the Director; require the establishment
of a data system of information regarding primary care and prevention
research that is conducted or supported by the NIH; require the
establishment of a clearinghouse to provide information on research
and prevention activities of the NIH that relate to primary care and
prevention research; and require a biennial report on primary care
and prevention research.
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Animal Research
Pet Safety and Protection Act of 2007
Number: S. 714 and H.R. 1280
Sponsor: Senator Daniel Akaka (D-HI) and
Representative Michael Doyle (D-PA)
Referred to: Senate Committee on Agriculture, Nutrition,
and Forestry; House Committee on Agriculture
Highlights:
Would amend the Animal Welfare Act to list permissible sources
of dogs and cats used by research facilities to include dogs and
cats obtained 1) from a licensed dealer, 2) from a publicly owned
and operated pound or shelter that meets specified requirements, 3)
by donation from the person who bred and raised the dog or cat and
owned it for not less than 1 year, or 4) from a research facility
licensed by the Secretary of Agriculture. It would increase monetary
penalties for related violations and would expressly prohibit Federal
facilities from purchasing or otherwise acquiring dogs or cats for
exhibition purposes, except from 1) the operator of an auction that
comports with legal requirements or 2) a person holding a valid dealer
or exhibitor license. The bill would also prohibit dealers from selling
to or otherwise providing a research facility with random-source dogs
or cats unless specified certification requirements were met.
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