Genomics and Personalized Medicine Act of 2006 - Requires the Secretary of Health and Human Services to: (1) establish the Genomics and Personalized Medicine Interagency Working Group to expand and accelerate genetics and genomics research and translate such research into clinical and public health applications; (2) expand and accelerate research and programs to collect genetic and genomic data that will advance the field of genomics and personalized medicine; (3) develop a plan for a national biobanking research initiative; (4) expand efforts to increase knowledge about the interaction between genetics and the environment and about ways in which molecular genetic screening, diagnostics, and treatments may be used to improve the health and health care of racial and ethnic minority populations; (5) increase recruitment and retention of trainees in genetics and genomics; (6) ensure the adequacy of genetics and genomics training for diagnosis, treatment, and counseling of adults and children for both rare and common disorders; (7) improve the safety, efficacy, and availability of information about genetic tests; and (8) improve the oversight and regulation of genetic tests.
Provides for the recruitment of health professionals from diverse backgrounds in the genomics workforce and improvement in the quality of genomics training.
Amends the Internal Revenue Code to establish a tax credit for qualified research expenses for the development of a qualified companion diagnostic test designed to provide information to increase the safety or effectiveness of a drug.
Provides for the expansion of adverse event reporting systems to encompass reports of adverse events resulting from genetic testing.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3822 Introduced in Senate (IS)]
109th CONGRESS
2d Session
S. 3822
To improve access to and appropriate utilization of valid, reliable and
accurate molecular genetic tests by all populations thus helping to
secure the promise of personalized medicine for all Americans.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 3, 2006
Mr. Obama introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To improve access to and appropriate utilization of valid, reliable and
accurate molecular genetic tests by all populations thus helping to
secure the promise of personalized medicine for all Americans.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Genomics and Personalized Medicine
Act of 2006''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) The completion of the Human Genome Project in 2003
paved the way for a more sophisticated understanding of disease
causation, which has contributed to the advent of
``personalized medicine''.
(2) Personalized medicine is the application of genomic and
molecular data to better target the delivery of health care,
facilitate the discovery and clinical testing of new products,
and help determine a patient's predisposition to a particular
disease or condition.
(3) Many commonly-used drugs are typically effective in
only 40 to 60 percent of the patient population.
(4) In the United States, up to 15 percent of hospitalized
patients experience a serious adverse drug reaction, and more
than 100,000 deaths are attributed annually to such reactions.
(5) Pharmacogenomics has the potential to dramatically
increase the efficacy and safety of drugs and reduce healthcare
costs, and is fundamental to the practice of genome-based
personalized medicine.
(6) Pharmacogenomics is the study of how genes affect a
person's response to drugs. This relatively new field combines
pharmacology (the science of drugs) and genomics (the study of
genes and their functions) to develop effective, safe
medications and dosing regimens that will be tailored to an
individual's genetic makeup.
(7) The cancer drug Gleevec was developed based on
knowledge of the chromosomal translocation that causes chronic
myelogenous leukemia, which is characterized by an abnormal
growth in the number of white blood cells. The mean 5-year
survival for affected patients who are treated with Gleevec is
95 percent, which contrasts to a 5-year survival of 50 percent
for patients treated with older therapies.
(8) The ERBB2 gene helps cells grow, divide and repair
themselves. One in 4 breast cancers are characterized by too
many copies of this gene, which causes uncontrolled and rapid
tumor growth. Pharmacogenomics research led to both the
development of the test for this type of breast cancer as well
as an effective biologic, Herceptin.
(9) Warfarin, a blood thinner used to prevent the formation
of life-threatening clots, significantly elevates patient risk
for bleeding in the head or gastrointestinal tract, both of
which are associated with increased rates of hospitalization,
disability and death. Pharmacogenomic researchers have
identified and developed tests for genetic variants in the
cytochrome P450 metabolizing enzyme (CYP2C9) and vitamin K
epoxide reductase complex that increase risk for these adverse
events. By using a companion diagnostic test for these two
genes, physicians can modify the dosing regimen and decrease
the likelihood of adverse events.
(10) Although the cancer drug 6-mercaptopurine (6-MP) cures
85 percent of children with acute lymphoblastic leukemia,
historically, a significant number of patients would die
inexplicably from the drug. Researchers later discovered that 1
in 10 individuals has an under-active version of the
metabolizing enzyme thiopurine methyltransferase (TPMT) and
should receive only a fraction of the standard dose of purine
drugs. Physicians now are able to screen for TPMT gene variants
before administering these drugs.
(11) Research into the genetics of breast cancer identified
two pivotal genes, BRCA1 and BRCA2, mutations in which
correspond to a significantly increased lifetime risk of
developing breast and ovarian cancer. Individuals in affected
families or with specific risk factors may use genetic testing
to identify whether they carry mutations in these genes and to
inform their decisions about treatment options, including
mastectomy and oophorectomy.
(12) Realizing the promise of personalized medicine will
require continued Federal leadership and agency collaboration,
expansion and acceleration of genomics research, a capable
genomics workforce, incentives to encourage development and
collection of data on the analytic and clinical validity of
genomic tests and therapies, and improved regulation over the
quality of genetic tests, direct-to-consumer advertising and
use of personal genomic information.
SEC. 3. DEFINITIONS.
In this Act:
(1) Biomarker.--The term ``biomarker'' means an analyte
found in a patient specimen that is objectively measured and
evaluated as an indicator of normal biologic processes,
pathogenic processes, or pharmacologic responses to a
therapeutic intervention.
(2) Laboratory-developed genetic test.--The term
``laboratory-developed genetic test'' means a molecular genetic
test that is designed, validated, conducted, and offered as a
service by a clinical laboratory subject to the Clinical
Laboratory Improvement Amendments (referred to in this Act as
``CLIA'') using either commercially available analyte specific
reagents (FDA-regulated) or reagents prepared by the laboratory
(not FDA-regulated), or some combination thereof.
(3) Molecular genetic test.--The term ``molecular genetic
test'' means an analysis of human DNA, RNA, chromosomes,
proteins, or metabolites, that detects genotypes, mutations, or
chromosomal and biochemical changes.
(4) Pharmacogenetic test.--The term ``pharmacogenetic
test'' means a molecular genetic test intended to identify
individual variations in DNA sequence related to drug
absorption and disposition (pharmacokinetics) or drug action
(pharmacodynamics), including polymorphic variation in the
genes that encode the functions of transporters, receptors,
metabolizing enzymes, and other proteins.
(5) Pharmacogenomic test.--
(A) In general.--The term ``pharmacogenomic test''
means a molecular genetic test intended to identify
individual variations in single-nucleotide
polymorphisms, haplotype markers, or alterations in
gene expression or inactivation, that may be correlated
with pharmacological function and therapeutic response.
(B) Variations and alterations.--For purposes of
this paragraph, the variations or alterations referred
to in subparagraph (A) may be a pattern or profile of
change, rather than a change in an individual marker.
(6) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 4. GENOMICS AND PERSONALIZED MEDICINE INTERAGENCY WORKING GROUP.
(a) In General.--The Secretary shall establish within the
Department of Health and Human Services the Genomics and Personalized
Medicine Interagency Working Group (referred to in this Act as the
``IWG'').
(b) Purpose.--It shall be the purpose of the IWG to expand and
accelerate genetics and genomics research, and the translation of
findings from such research into clinical and public health
application, by--
(1)(A) enhancing communication about current and proposed
activities and areas of focus by the Department of Health and
Human Services and other relevant Federal departments and
agencies, including communication focused on findings and
recommendations from--
(i) the advisory groups on genetics of the
Secretary, including the Secretary's Advisory Committee
on Genetics, Health, and Society, and the Advisory
Committee on Heritable Disorders and Genetic Diseases
in Newborns and Children; and
(ii) the National Academies of Science, including
the Institute of Medicine; and
(B) identifying areas of need and opportunity; and
(2) facilitating collaboration, coordination, and
integration of activities, within the Federal agencies, and
among such agencies and their public and private partners to
leverage resources and avoid duplication of effort.
(c) IWG Chairperson.--The Secretary shall serve as chairperson of
the IWG. The Secretary may not designate another person to serve as a
chairperson of the IWG.
(d) Members.--In addition to the Secretary, the IWG shall include
members from the--
(1) National Institutes of Health, including the National
Human Genome Research Institute, the National Institute of
Environmental Health Sciences, the Department of Clinical
Bioethics, and the National Center on Minority Health and
Health Disparities;
(2) Centers for Disease Control and Prevention, including
the Office of Genomics and Disease Prevention;
(3) Food and Drug Administration, including the Office of
Clinical Pharmacology and Biopharmaceutics Review and the
Office of In Vitro Diagnostics;
(4) Health Resources and Services Administration, including
the genetic services branch of the Maternal and Child Health
Bureau and the Bureau of Health Professions;
(5) Office of Minority Health;
(6) Agency for Healthcare Research and Quality;
(7) Centers for Medicare & Medicaid Services;
(8) Veterans Health Administration;
(9) Office of the National Coordinator for Health
Information Technology;
(10) Department of Energy, including the Human Genome
Program and Joint Genome Institute of the Office of Science;
and
(11) other Federal departments and agencies as determined
appropriate by the Secretaries.
(e) Duties of the IWG.--In fulfilling the purpose described in
subsection (b), members of the IWG shall--
(1) meet not less frequently than twice each year or at the
call of the chairperson;
(2) draft recommendations for various heads of Federal
departments and agencies; and
(3) provide opportunities for public input and comment on
the deliberations and activities of the IWG, as appropriate.
(f) Report.--Not later than 1 year after the date of enactment of
this Act, and biennially thereafter, the Secretary shall report to the
appropriate committees of Congress and to the public on IWG activities,
with respect to meeting the purpose described in subsection (b) and
carrying out the duties described in subsection (e).
(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $5,000,000 for fiscal year
2007, and such sums as may be necessary for each of fiscal years 2008
through 2012.
SEC. 5. EXPANSION AND ACCELERATION OF GENETIC AND GENOMICS RESEARCH.
(a) Genetics and Genomics Research.--
(1) In general.--The Secretary shall expand and accelerate
research and programs to collect genetic and genomic data that
will advance the field of genomics and personalized medicine,
with prioritized focus on--
(A) studies of diseases and health conditions with
substantial public health impact;
(B) population-based studies of genotype
prevalence, gene-disease association, gene-drug
response association, and gene-environment
interactions;
(C) systematic review and synthesis of the results
of population-based studies using methods of human
genome epidemiology;
(D) translation of genomic information into
molecular genetic screening tools, diagnostics, and
therapeutics, through well-conducted clinical trials
and studies;
(E) translation of genomic information into tools
for public health investigations and ongoing
biosurveillance and monitoring;
(F) systematic review of data on analytic validity
and clinical validity of molecular genetic tests;
(G) comprehensive studies of clinical utility,
including cost-effectiveness and cost-benefit analyses,
of molecular genetic tests and therapeutics;
(H) population based studies to assess the
awareness, knowledge, and use of genetic tests and
their impact on the population health and health
disparities; and
(I) methods to enhance provider uptake or adoption
of pharmacogenomic products into practice.
(2) Biobanking.--
(A) National biobanking research initiative.--The
Secretary, in collaboration with the IWG, shall develop
a plan for a national biobanking research initiative
that--
(i) addresses priority areas of focus, as
described in paragraph (1);
(ii) builds upon current genomic research
initiatives (existing as of the date the plan
is issued) domestically and, as practicable,
internationally;
(iii) is prospective and long-term in
design;
(iv) takes into consideration public review
and comment;
(v) is designed to support collection and
synthesis of evidence for public health and
clinical applications;
(vi) meets rigorous standards and
guidelines regarding ethics, legality, and
social issues;
(vii) ensures diverse representation of
individuals in the research or data collection
that would allow statistically significant
analyses of population subgroups as
appropriate; and
(viii) reflects public-private partnership.
(B) National biobanking distributed database.--
(i) In general.--The Secretary, acting
through the Director of the National Human
Genome Research Institute at the National
Institutes of Health and the Director of the
Office of Genomics and Disease Prevention at
the Centers for Disease Control and Prevention,
shall establish a system for the integration of
data, including genomic data and associated
environmental and clinical health information,
which shall facilitate the pooled analysis and
synthesis of such data.
(ii) Distributed database.--With respect to
such national biobanking database, the
Secretary shall--
(I) establish a grant program for
local or regional biobanking
initiatives, in accordance with
subparagraph (C), with priority given
for local or regional biobanks that--
(aa) are established or
complement activities related
to the implementation of the
national biobanking research
initiative, pursuant to
subparagraph (A);
(bb) are based on well-
defined populations, such as
cohorts of newborn infants
screened by State health
departments for metabolic
disorders, population-based
registries of cancer and other
diseases, and family-based
registries;
(cc) collect data from
participants with diverse
genetic profiles, environmental
exposures, and health
conditions and diseases; and
(dd) participate in and
contribute data to consortia
established to develop and
apply best practices and
standards in the research area
of such consortium;
(II) assist in the development of
uniform standards and guidelines for
the collection, submission, and storage
of biobank data;
(III) develop and promulgate
guidelines regarding procedures,
protocols, and policies for access of
data by non-governmental entities and
the safeguarding of the privacy of
biobank subjects, in accordance with
the Office for Human Research
Protection and Clinical Research Policy
Analysis and Coordination program at
the National Institutes of Health, and
other guidelines as appropriate;
(IV) review and make
recommendations to address ownership
issues with respect to genomic samples
and analyses;
(V) encourage voluntary submission
of biobanking data obtained or analyzed
with private or non-Federal funds;
(VI) facilitate submission of data,
including secure and efficient
electronic submission;
(VII) incorporate data from Federal
surveys, such as the National Health
and Nutrition Examination Survey;
(VIII) develop and disseminate
standard consent forms, including those
that allow multiple uses of data for
research purposes;
(IX) conduct, directly or by
contract, analytical research,
including clinical, epidemiological,
and social research, using biobank
data;
(X) allow public use of data only--
(aa) with appropriate
privacy safeguards in place;
and
(bb) for health research
purposes;
(XI) determine appropriate
procedures for industry access to
biobank data for research and
development of new or improved tests
and treatments, and submission of data
generated from such samples to the Food
and Drug Administration as part of the
approval process for drugs and devices;
and
(XII) make analytic findings from
biobanking initiatives supported by
Federal funding publicly available
within an appropriate timeframe to be
determined by the Secretary, which
findings shall not contain identifiable
information of patients.
(iii) National resources.--The IWG shall
sponsor national efforts to bring together the
consortia described in clause (ii)(I)(dd) to
build national data resources.
(C) Biobank initiatives grants.--
(i) In general.--The Secretary shall
establish a grant program for eligible
institutions to enable the institutions to
develop or expand biobanking initiatives to
advance the application of genomics to the
practice of medicine and contribute to the
understanding of the genetic causes of disease.
(ii) Eligibility.--An academic medical
center or other institution shall be eligible
for a grant under this subparagraph if the
center or institution has--
(I) practical experience and
demonstrated expertise in genomics and
its clinical and public health
applications;
(II) an established scientific
advisory committee to--
(aa) advise staff on
genomic issues, including
related ethical, legal, and
social issues;
(bb) evaluate and approve
research studies utilizing the
biobank data; and
(cc) provide a forum for
evidence-based reviews and
integration of research
findings to determine if and
how such findings may be used
in health care and disease
prevention;
(III) an established community
advisory committee comprised of
community advocates, potential study
participants, and other stakeholders,
to--
(aa) provide a non-
scientific perspective on the
biobanking initiative;
(bb) guide the development
of patient-oriented materials;
(cc) support outreach to
minority and other underserved
communities; and
(dd) provide a forum for
the discussion of ethical,
social, and legal issues
pertaining to the biobanking
initiative;
(IV) mechanisms to ensure patient
privacy and protection of information
from non-health applications; and
(V) a demonstrated ability to
recruit patients from diverse cultural
backgrounds.
(iii) Use of funds.--An eligible
institution that receives a grant under this
subparagraph shall use the grant funds to
develop or expand a biobanking initiative,
which may include the following activities:
(I) Support for advisory
committees.
(II) Recruitment and education of
patients.
(III) Development of consent
protocols.
(IV) Obtaining genetic samples and
clinical information.
(V) Establishment and maintenance
of secure storage for genetic samples
and clinical information.
(VI) Conduct of data analyses and
evidence-based systemic reviews that
allow for the following:
(aa) Identification of
biomarkers and other surrogate
markers to improve predictions
of onset of disease, response
to therapy, and clinical
outcomes.
(bb) Increased
understanding of gene-
environment interactions.
(cc) Development of
molecular genetic screening,
diagnostic, and therapeutic
interventions.
(dd) Genotypic
characterization of tissue
samples.
(VII) Support for participation in
research consortia concerned with
establishing and developing best
practices and standards in the relevant
research areas.
(VIII) Development and
implementation of protocols for
external researchers to access non-
identifiable patient samples and
associated health information for
research activities.
(IX) Other activities, as
determined appropriate by the
Secretary.
(b) Race, Genomics, and Health.--
(1) In general.--The Secretary shall expand and intensify
efforts to increase knowledge about the--
(A) interaction between genetics and the
environment, and the influence of such interaction on
the causality and treatment of diseases common in
racial and ethnic minority populations; and
(B) ways in which molecular genetic screening,
diagnostics, and treatments may be used to improve the
health and health care of racial and ethnic minority
populations.
(2) Race and genomics.--Not later than 1 year after the
date of enactment of this Act, the Secretary, in collaboration
with the IWG, shall prepare, with public input, and publish
trans-agency guidance regarding the following:
(A) An appropriate definition for race and
ethnicity for use in genomic research and programs
operated or supported by the Federal Government.
(B) Guiding ethics, principles, and protocols for
the inclusion and designation of racial and ethnic
populations in genomics research and programs operated
or supported by the Federal Government.
(C) Ways to increase access to effective
pharmacogenomic and other clinical genetic services for
minority populations.
(D) Research opportunities and funding support in
the area of race and genomics that may improve the
health and health care of minority populations.
(E) Ways to enhance integration of Federal
Government-wide efforts and activities pertaining to
race, genomics, and health.
(F) Any needs for additional privacy protections in
preventing stigmatization and inappropriate use of
genetic information.
(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $150,000,000 for fiscal year
2007, and such sums as may be necessary for each of fiscal years 2008
through 2012.
SEC. 6. GENOMICS WORKFORCE AND TRAINING.
(a) In General.--The Secretary, acting through the Administrator of
the Health Resources and Services Administration and the Director of
the Centers for Disease Control and Prevention, and in collaboration
with the IWG, shall expand and intensify efforts to--
(1) support efforts to recruit and retain health
professionals from diverse backgrounds in the genomics
workforce;
(2) in collaboration with appropriate professional
accreditation organizations, assess and make recommendations to
improve the quality of genomics training; and
(3) develop a plan to integrate genomics into all aspects
of health professional training.
(b) Eligible Entity.--For purposes of this section, the term
``eligible entity'' includes professional genetics and genomics
societies and academic institutions determined appropriate by the
Secretary.
(c) Recruitment and Retention.--The Secretary shall provide
financial and technical support to eligible entities to increase
recruitment and retention of trainees in genetics and genomics by--
(1) providing education and awareness opportunities,
practical and research experiences, and financial incentives
such as scholarships or loan repayment;
(2) considering development of genomic subspecialty
fellowships or concentrations within genetics training
programs;
(3) considering development of combined residency programs
or joint subspecialty fellowships with other specialties;
(4) providing support for laboratory-based genetics or
genomics fellowships for medical and other health professional
students; and
(5) carrying out other activities determined appropriate by
the Secretary.
(d) Genetics and Genomics Training.--The Secretary, directly or
through contracts or grants to eligible entities, shall ensure the
adequacy of genetics and genomics training for diagnosis, treatment,
and counseling of adults and children for both rare and common
disorders, through support of efforts to--
(1) strengthen the core training content of the various
clinical disciplines to reflect new knowledge and evolving
practice of genetics and genomics;
(2) develop and disseminate model residency and other
training program curricula and teaching materials that
integrate and broaden the base of medical genetics and genomics
training;
(3) assist the review of board and other certifying
examinations by professional societies and accreditation bodies
to ensure adequate focus on the fundamental principles of
genomics; and
(4) explore options for distance or on-line learning for
degree or continuing education programs.
(e) Integration.--The Secretary shall support initiatives to
increase the integration of genetics and genomics into all aspects of
clinical and public health practice by--
(1) generating greater awareness of the relevance and
application of genetics and genomics to common disorders; and
(2) promoting genetics and genomics competency across all
clinical, public health and laboratory disciplines through the
development and dissemination of health professional guidelines
which shall--
(A) include focus on appropriate administration and
interpretation of genomic tests, and subsequent
clinical and public health decision-making; and
(B) specifically target health professionals
without formal training or experience in the field of
genomics.
(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $10,000,000 for fiscal year 2007
and such sums as may be necessary for each of fiscal years 2008 through
2012.
SEC. 7. REALIZING THE POTENTIAL OF PERSONALIZED MEDICINE.
(a) Incentives.--
(1) Tax credit for research and development related to
companion diagnostic tests.--
(A) In general.--Subpart D of part IV of subchapter
A of chapter 1 of the Internal Revenue Code of 1986 is
amended by adding at the end the following new section:
``SEC. 45N. COMPANION DIAGNOSTIC TEST CREDIT.
``(a) Allowance of Credit.--For purposes of section 38, in the case
of an eligible taxpayer, the companion diagnostic test credit for any
taxable year is an amount equal to the qualified research expenses paid
or incurred by the taxpayer during the taxable year in connection with
the development of a qualified companion diagnostic test .
``(b) Eligible Taxpayer.--For purposes of this section, the term
`eligible taxpayer' means a taxpayer who has been requested to develop
a qualified companion diagnostic test by the Secretary of Health and
Human Services in connection with a drug--
``(1) for which an application has been submitted under
section 501(b)(1) of the Federal Food, Drug, and Cosmetic Act,
or
``(2) for which an application has been approved under such
section.
``(c) Qualified Companion Diagnostic Test.--For purposes of this
section, the term `qualified companion diagnostic test' means a
diagnostic test in connection with a drug which--
``(1) is designed to provide information which can be used
to increase the safety or effectiveness of the drug, and
``(2) is approved by the Secretary of Health and Human
Services.
``(d) Qualified Research Expenses.--For purposes of this section,
the term `qualified research expenses' has the meaning given to such
term under section 41(b).
``(e) No Double Benefit.--
``(1) Coordination with other deductions and credits.--
Except as provided in paragraph (2), the amount of any
deduction or other credit allowable under this chapter for any
expense taken into account in determining the amount of the
credit under subsection (a) shall be reduced by the amount of
such credit attributable to such expense.
``(2) Research and development costs.--
``(A) In general.--Except as provided in
subparagraph (B), any amount which is taken into
account in determining the amount of the credit under
subsection (a) for any taxable year shall not be taken
into account for purposes of determining the credit
under section 41 for such taxable year.
``(B) Costs taken into account in determining base
period research expenses.--Any amount taken into
account in determining the amount of the credit under
subsection (a) for any taxable year shall be taken into
account in determining base period research expenses
for purposes of applying section 41 to subsequent
taxable years.
``(f) Regulations.--The Secretary, in consultation with the
Secretary of Health and Human Services, shall promulgate such
regulations as are necessary to carry out the purposes of this section.
``(g) Termination.--This section shall not apply to expenses paid
or incurred in taxable years beginning after the date which is 5 years
after the date of enactment of this section.''.
(B) Credit treated as part of general business
credit.--Section 38(b) of the Internal Revenue Code of
1986 is amended by striking ``and'' at the end of
paragraph (29), by striking the period at the end of
paragraph (30) and inserting ``, plus'', and by adding
at the end the following new paragraph:
``(31) the companion diagnostic test credit determined
under section 45N(a).''.
(C) Clerical amendment.--The table of sections for
subpart D of subchapter A of chapter 1 of the Internal
Revenue Code of 1986 is amended by adding at the end
the following new item:
``Sec. 45N. Companion diagnostic test credit.''.
(D) Effective date.--The amendments made by this
paragraph shall apply to expenses paid or incurred in
taxable years beginning after the date of enactment of
this Act.
(2) National academy of sciences study.--Not later than 6
months after the date of enactment of this Act, the Secretary
shall enter into a contract with the National Research Council
of the National Academy of Sciences to study and recommend
appropriate incentives to encourage--
(A) co-development of companion diagnostic testing
by a drug sponsor;
(B) development of companion diagnostic testing for
already-approved drugs by the drug sponsor;
(C) companion diagnostic test development by device
companies that are not affiliated with the drug
sponsor; and
(D) action on other issues determined appropriate
by the Secretary.
(b) Genetic Test Quality.--
(1) In general.--The Secretary shall improve the safety,
efficacy, and availability of information about genetic tests,
including pharmacogenetic and pharmacogenomic tests.
(2) Institute of medicine study.--Not later than 30 days
after the date of enactment of this Act, the Secretary shall
enter into a contract with the Institute of Medicine to conduct
a study and a prepare a report that includes recommendations to
improve Federal oversight and regulation of genetic tests, with
specific recommendations on the development of the decision
matrix under paragraph (3). Such study shall be completed not
later than 1 year after the date on which such contract was
entered into.
(3) Decision matrix.--
(A) In general.--The Secretary, taking into
consideration the recommendations of the Institute of
Medicine report under paragraph (2), shall develop a
decision matrix (referred to in this section as the
``matrix'') to improve the oversight and regulation of
genetic tests, including pharmacogenomics and
pharmacogenetic tests by--
(i) determining the classification of
genetic tests that have not yet been
classified, or of which the classification is
unclear, questioned, or challenged;
(ii) determining which types of tests,
including laboratory-developed tests, require
review and the level of review needed for such
tests;
(iii) determining which agency shall have
oversight over the review process of such tests
that are determined to require review; and
(iv) determining, to the extent
practicable, which requirements the agency
shall apply to the types of tests identified in
clause (ii).
(B) Level of review.--In determining the level of
review needed by a genetic test, the Secretary shall
take into consideration--
(i) characteristics of the test and its
target disease or condition;
(ii) intended use of the test;
(iii) potential for improved medical
conditions and patient harms; and
(iv) social consequences of the test.
(C) Comparative analysis.--To inform development of
the matrix, the Secretary shall undertake a comparative
analysis of laboratory review requirements under the
Clinical Laboratory Improvement Act and those of the
Food and Drug Administration to assess and reduce
differences in such requirements, and to eliminate
redundancies and decrease burden of review, as
practicable.
(D) Regulations.--Not later than 30 months after
the date of enactment of this Act, the Secretary shall
promulgate regulations to implement the matrix.
(4) Adverse events.--The Secretary, acting through the
Commissioner of Food and Drugs and the Administrator of the
Centers for Medicare & Medicaid Services, shall--
(A) develop or expand adverse event reporting
systems to encompass reports of adverse events
resulting from genetic testing; and
(B) respond appropriately to any adverse events
resulting from such testing.
(5) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection, $10,000,000
for fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2012.
(c) Food and Drug Administration.--
(1) In general.--
(A) Summary information.--If a genetic test that is
determined to be within the jurisdiction of the Food
and Drug Administration but that does not require
review, as determined under the matrix, the sponsor of
such test shall provide the Secretary with summary
information on how the test was validated and its
performance characteristics, which information shall be
made easily accessible for the public.
(B) Source of information.--The information
described under subparagraph (A) may be obtained from
the labeling submitted for CLIA complexity
categorization.
(2) Requirement for companion diagnostic testing.--The
Secretary may require the sponsor of a drug or biological
product--
(A) to codevelop a companion diagnostic test, after
filing an investigational new drug application or a new
drug application to address significant safety concerns
of the drug or biological product;
(B) to develop a companion diagnostic test if phase
IV data demonstrate significant safety or effectiveness
concerns with use of the drug or biological product;
and
(C) to relabel the drug or biological product to
require validated companion diagnostic testing when
evidence of improved outcomes has been established in
practice or if data demonstrate significant safety
concerns with use of such drug or biological product.
(3) Pharmacogenomic data submission.--The Secretary shall
encourage and facilitate voluntary pharmacogenomic data
submission from drug sponsors, which may include--
(A) the development and dissemination of guidance
on relevant policies, procedure and practice regarding
such submission;
(B) the provision of technical assistance;
(C) the establishment of a mechanism to store,
maintain and analyze such data, in collaboration with
the National Institutes of Health and the Centers for
Disease Control and Prevention;
(D) determining when such data may be used to
support an investigational new drug or a new drug
application;
(E) the conduct of a study of the use of genomic
approaches to understand and reduce adverse drug
reactions; and
(F) other activities determined appropriate by the
Commissioner.
(4) Labeling for certain groups.--Not later than 6 months
of enactment of this Act, the Secretary shall prepare and
publish guidance regarding the approval, licensing, or
clearance of any product under the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the
Public Health Service Act (42 U.S.C. 262) with an indication,
contraindication, warning, or any other labeling information
that is specific to a racial or ethnic group.
(5) Termination of certain advertising campaigns.--The Food
and Drug Administration shall collaborate with the Federal
Trade Commission to identify and terminate, pursuant to section
5 of the Federal Trade Commission Act (15 U.S.C. 45),
advertising campaigns that make false, misleading, deceptive,
or unfair claims about molecular genetic tests.
(d) Centers for Medicare & Medicaid Services.--
(1) In general.--If a genetic test that is determined to be
within the jurisdiction of the Centers for Medicare & Medicaid
Services does not require review as determined under the
matrix, the sponsor of such test shall provide the
Administrator of the Centers for Medicare & Medicaid Services
with summary information on how the test was validated and its
performance characteristics, which information shall be made
easily accessible for the public.
(2) Specialty area.--To ensure the accuracy, validity, and
reliability of clinical genetic tests that do not require
premarket approval by or notification to the Food and Drug
Administration, and to improve oversight of genetic test
laboratories, the Director of the Division of Laboratory
Services of the Survey and Certification Group of the Center
for Medicaid and State Operations of the Centers for Medicare &
Medicaid Services, in collaboration with the Clinical
Laboratory Improvement Advisory Committee at the Centers for
Disease Control and Prevention, shall establish a specialty
area for molecular and biochemical genetic tests, in order to--
(A) develop criteria for establishing analytic and
clinical validity for genetic tests that are determined
to require review under the matrix;
(B) specify requirements for proficiency testing
for laboratories;
(C) provide guidance regarding the scope of duty
for laboratory directors;
(D) make information easily accessible to the
public about--
(i) laboratory certification; and
(ii) analytic and clinical validity for
genetic tests that are determined to require
high level review under the matrix; and
(E) conduct other activities at the discretion of
the Administrator of the Centers for Medicare &
Medicaid Services.
(3) Reimbursement.--To foster adoption of molecular genetic
screening tools, the Administrator of the Centers for Medicare
& Medicaid Services shall--
(A) assess and update current procedure terminology
codes as warranted; and
(B) determine and implement fair and reasonable
coverage policies and reimbursement rates for medically
necessary genetic and genomic treatments and services,
including laboratory testing.
(e) Centers for Disease Control and Prevention.--
(1) Direct-to-consumer marketing.--Not later than 12 months
after the date of enactment of this Act, the Director of the
Centers for Disease Control and Prevention, with respect to
molecular genetic tests for which consumers have direct access,
shall--
(A) conduct an analysis of the public health impact
of direct-to-consumer marketing to the extent possible
from available data sources;
(B) analyze the validity of claims made in direct-
to-consumer marketing; and
(C) make recommendations to Congress regarding
necessary interventions to protect the public from
potential harms of direct-to-consumer marketing and
access to molecular genetic tests.
(2) Public awareness.--The Director shall expand efforts to
educate and increase awareness of the general public about
genomics and its applications to improve health, prevent
disease and eliminate health disparities. Such efforts shall
include the--
(A) ongoing collection of data on the awareness,
knowledge and use of genetic tests through public
health surveillance systems, and analysis of the impact
of such tests on population health; and
(B) integration of the use of validated genetic and
genomic tests in public health programs as appropriate.
(3) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection, $30,000,000
for fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2012.
(f) Agency for Healthcare Research and Quality.--The Director of
the Agency for Healthcare Research and Quality, after consultation with
the IWG and other public and private organizations, as appropriate,
shall support the assessment of the clinical utility and cost-
effectiveness of companion diagnostic tests that guide prescribing
decisions, through research that--
(1) develops standardized tools and methodologies to assess
the cost-effectiveness of such tests, as well as criteria for
use;
(2) establishes and validates drug dosing algorithms for
which such tests can improve outcomes, taking into
consideration--
(A) a reduction in toxicity, adverse events, and
mortality;
(B) improved clinical outcomes and quality of life,
including decreased requirements for monitoring and
laboratory testing; and
(C) the impact on the direct and indirect costs of
health care, which may include costs due to length of
hospital stay, length of time to identify safe and
effective dosing for patients, toxicity and adverse
events, and other measures of health care utilization
and outcomes;
(3) accelerates development and rapid adoption by providers
and payers as appropriate, of companion diagnostic testing that
could significantly enhance the safety of a medication by
identifying patients at risk for toxic events from use of such
medication or by improving dosing regimens for such medication;
and
(4) prioritizes the development of such tests for diseases
and health conditions that have a significant public health
impact because of prevalence, risk of complications from
treatment, and other factors determined appropriate by the
Director.
(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $30,000,000 for fiscal year
2007, and such sums as may be necessary for each of fiscal years 2008
through 2012.
SEC. 8. SENSE OF THE SENATE REGARDING GENETIC NON-DISCRIMINATION AND
PRIVACY.
It is the sense of the Senate that--
(1) in order for personalized medicine to advance and
achieve success in both reducing the burden of disease and
reducing health care costs, strong privacy protections,
including protections against genetic discrimination, must be
enacted and implemented;
(2) without a Federal law banning genetic discrimination,
people may fear losing their health insurance and their
employment, and subsequently--
(A) avoid participating in research that collects
genetic information; and
(B) even decline clinical molecular testing that
may provide lifesaving information;
(3) fear of genetic discrimination will slow the pace of
discovery in research and hinder the uptake of molecular
testing in a clinical setting, both of which will undermine
efforts to translate and apply personalized medicine
technology; and
(4) adequate privacy protections, including a Federal
prohibition against genetic discrimination, are necessary
prerequisites to advancing personalized medicine.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S8840-8841)
Read twice and referred to the Committee on Finance.
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