110 HR 6498 IH: Genomics and Personalized Medicine Act
U.S. House of Representatives
2008-07-15
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the
Genomics and Personalized Medicine Act
of 2008
.
2.The Congress makes the following
findings:
(1)The completion of
the Human Genome Project in 2003 paved the way for a more sophisticated
understanding of diseases and drug responses, 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, help determine a person’s predisposition to a particular disease or
condition, and identify any targeted prevention strategies for that
predisposition.
(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 as many as 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 health care costs, and is fundamental to the practice of genome-based
personalized medicine.
(6)Pharmacogenomics
is the study of drug response in the context of the entire genome. This
relatively new field combines pharmacology (the science of drugs) and genomics
(the study of genes and their functions) to develop safer and more effective
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 extra 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 gas trointestinal 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 300
individuals have only a non-functional form of the metabolizing enzyme
thiopurine methyltransferase (TPMT) and, as a result, should receive only a
fraction of the standard dose of 6
(11)Research into the
genetics of breast cancer identified two pivotal genes, BRCA1 and BRCA2,
mutations 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 prophylactic 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 and clinical utility of genomic
tests and therapies, and improved regulation over the quality of genetic tests,
direct-to consumer advertising of genetic tests, and use of personal genomic
information.
3.In this Act:
(1)The
term biobank
means a shared repository of human biological
specimens that may also include data associated with such specimens collected
for medical or research purposes. Human biological specimens may include body
fluids, tissues, blood, cells, or materials derived from these sources, and
data associated with such specimens may include health information or
environmental data.
(2)The
term biomarker
means an analyte found in or derived from 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.
(3)The
term CLIA
means section 353 of the Public Health Service Act (42
U.S.C. 263a; commonly referred to as the Clinical Laboratory Improvement
Amendments of 1988
).
(4)The
term environment
means conditions or circumstances that are
nongenetic but may have a health impact.
(5)The term genetic test
means an analysis of
human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes,
mutations, or chromosomal changes.
(6)The term IWG
means the
Genomics and Personalized Medicine Interagency Working Group established
pursuant to section 4.
(7)
(A)The term pharmacogenetic test
means a
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, or other genomic variations, including rearrangements, insertions,
and deletions, or alterations in gene expression or inactivation, that may be
correlated with pharmacological function and therapeutic response.
(B)Variations and
alterationsFor 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.
(8)The
term Secretary
means the Secretary of Health and Human
Services.
4.Genomics and
personalized medicine inter agency working group
(a)Not later than 90 days after the date of the enactment of
this Act, the Secretary shall establish within the Department of Health and
Human Services the Genomics and Personalized Medicine Interagency Working Group
(IWG
).
(b)The
IWG shall facilitate collaboration, coordination, and integration of activities
within the Department of Health and Human Services and other Federal agencies,
and among such agencies and relevant public and private entities, by—
(1)reviewing current
and proposed genomic initiatives, in order to identify shared interests and
leverage resources;
(2)prioritizing new
genomic initiatives, based on areas of need as measured by public health
impact;
(3)reaching consensus
on standardized genomic terminology, definitions, and data code sets for
adoption and use in federally conducted or supported programs;
(4)establishing and
disseminating quality standards and guidelines for the collection, processing,
archiving, storage, and dissemination of genomic samples and data for research
and clinical purposes;
(5)developing and
promulgating guidelines regarding procedures, protocols, and policies for 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;
(6)reviewing and
making recommendations to address ownership and patient access issues with
respect to genomic samples and analyses;
(7)developing and
promulgating guidelines regarding procedures, protocols, and policies for
access to patient data, genomic samples, and associated health information by
nongovernmental entities for research purposes;
(8)developing and
disseminating guidelines for constructing informed consent forms that ensure
patient privacy and confidentiality of associated clinical data and
information, understanding of research procedures, benefits, risks, rights, and
responsibilities, and continuous voluntary participation; and
(9)providing
recommendations for the establishment of a distributed database, pursuant to
section 5.
(c)The Secretary, or his or her designee, shall serve as
chairperson of the IWG.
(d)In
addition to the Secretary, the IWG shall include members from—
(1)the National
Institutes of Health;
(2)the Centers for
Disease Control and Prevention;
(3)the Food and Drug
Administration;
(4)the Health
Resources and Services Administration;
(5)the Office of
Minority Health;
(6)the Agency for
Healthcare Research and Quality;
(7)the Centers for
Medicare & Medicaid Services;
(8)the Veterans
Health Administration;
(9)the Office of the
National Coordinator for Health Information Technology;
(10)the Department of
Energy;
(11)the Armed Forces
Institute of Pathology;
(12)the Indian Health
Service;
(13)other Federal
departments; and
(14)such other
agencies as determined appropriate by the Secretary.
(e)The IWG shall solicit input from relevant stakeholders with
respect to meeting the duties described in subsection (b).
(f)Not
later than 18 months after the date of the enactment of this Act, the Secretary
shall prepare and submit a report to the appropriate committees of the Congress
and to the public on IWG deliberations, activities, and recommendations with
respect to meeting the duties described in subsection (b).
(g)The
IWG shall terminate after submitting the report described in subsection (f), or
later at the discretion of the Secretary.
(h)Authorization of
appropriationsThere is authorized to be appropriated to carry
out this section, $5,000,000 for each of fiscal years 2009 and 2010.
5.Expansion and
acceleration of genetic and genomics research
(a)Genetics and
genomics researchThe 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—
(1)studies of
diseases and health conditions with substantial public health impact;
(2)population-based
studies of genotype prevalence, gene-disease association, gene-drug response
association, and gene-environment interactions;
(3)systematic review
and synthesis of the results of population-based studies using methods of human
genome epidemiology;
(4)translation of
genomic information into molecular genetic screening tools, diagnostics, and
therapeutics, through well-conducted clinical trials and studies;
(5)translation of
genomic information into tools for public health investigations and ongoing
biosurveillance and monitoring;
(6)systematic review
of data on analytic validity and clinical validity of molecular genetic
tests;
(7)comprehensive
studies of clinical utility, including cost-effectiveness and cost-benefit
analyses, of molecular genetic tests and therapeutics;
(8)population-based
studies to assess the awareness, knowledge, and use of genetic tests and their
impact on the population health and health disparities; and
(9)methods to enhance
provider uptake or adoption of pharmacogenomic products into practice.
(b)National
biobanking initiative
(1)The Secretary shall advance the field of genomics and
personalized medicine through establishment of a national biobanking
distributed database for the collection and integration of genomic data, and
associated environmental and clinical health information, which shall
facilitate synthesis and pooled analysis of such data.
(2)With
respect to the national biobanking distributed database, the Secretary
shall—
(A)adhere to relevant
guidelines, policies, and recommendations of the IWG, pursuant to section
4;
(B)establish,
directly or by contract, a single point of authority to manage operations of
the database;
(C)incorporate
biobanking data from federally conducted or supported genomics initiatives, as
feasible;
(D)encourage
voluntary submission of biobanking data obtained or analyzed with private or
non-Federal funds;
(E)facilitate
submission of data, including secure and efficient electronic
submission;
(F)allow public use
of data only—
(i)with
appropriate privacy safeguards in place; and
(ii)for
health research purposes;
(G)determine
appropriate procedures for access by nongovernmental entities 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;
(H)conduct, directly
or by contract, analytical research, including clinical, epidemiological, and
social research, using biobank data; and
(I)make analytic
findings from biobanking initiatives supported by Federal funding publicly
available within an appropriate timeframe to be determined by the
Secretary.
(3)Nothing in this subsection shall be construed to
require the submission or acceptance of biological specimens.
(c)Biobank
initiatives grants
(1)The Secretary shall establish a grant program for
eligible entities to develop or expand biobanking initiatives to increase
understanding of how genomics interacts with environmental factors to cause
disease, and to accelerate the development of genomic-based tests and
treatments.
(2)
(A)For purposes of this subsection, eligible entities
include academic medical centers and other entities determined appropriate by
the Secretary. Eligible entities desiring a grant under this subsection shall
submit an application to the Secretary in accordance with this subsection, at
such time, in such manner, and containing such additional information as the
Secretary may require.
(B)Academic
medical centers that partner with health care professionals within their
communities in order to obtain diverse genomic samples shall be given priority
for awards made under this subsection.
(3)The
Secretary shall ensure that biobanks supported by grant awards under this
subsection—
(A)adhere to
guidelines and recommendations developed pursuant to section 4;
(B)are established to
complement activities related to the implementation of current Federal
biobanking research initiatives, as feasible;
(C)are based on
well-defined populations, including population-based registries of disease and
family-based registries;
(D)collect data from
participants with diverse genomic profiles, demographics, environmental
exposures, and presence or absence of health conditions and diseases, as
appropriate;
(E)meet quality
standards developed by the IWG pursuant to section 4 for the collection,
processing, archiving, storage, and dissemination of data;
(F)have practical
experience and demonstrated expertise in genomics and its clinical and public
health applications;
(G)establish
mechanisms to ensure patient privacy and protection of information from
nonhealth applications and, as feasible, patient access to genomic samples for
clinical testing purposes; and
(H)contribute genomic
and associated clinical and environmental data and analyses to the national
biobanking distributed database, established pursuant to subsection (b).
(4)An eligible entity that receives a grant under this
subsection shall use the grant funds to develop or expand a biobanking
initiative, which may include the following activities:
(A)Support for
scientific and community advisory committees.
(B)Recruitment and
education of participants.
(C)Development of
consent protocols.
(D)Obtaining genetic
samples and associated environmental and clinical information.
(E)Establishment and
maintenance of secure storage for genetic samples and clinical
information.
(F)Conduct of data
analyses and evidence-based systemic reviews that allow for the
following:
(i)Identification of
biomarkers and other surrogate markers to improve predictions of onset of
disease, response to therapy, and clinical outcomes.
(ii)Increased
understanding of gene environment interactions.
(iii)Development of
genetic screening, diagnostic, and therapeutic interventions.
(iv)Genotypic
characterization of tissue samples.
(G)Other activities,
as determined appropriate by the Secretary.
(5)The Secretary may enter into a contract with an
external entity to evaluate grantees under this subsection to ensure that
quality standards are met.
(d)Application of
privacy rulesNothing in this Act or the amendments made by this
Act shall be construed to supercede the requirements for the protection of
patient privacy under—
(1)the Federal
regulations promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note);
(2)sections 552 and
552a of title 5, United States Code (5 U.S.C. App.); or
(3)the Genetic
Information Nondiscrimination Act of 2008 (Public Law 110–233).
(e)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section, $150,000,000 for fiscal year 2009, and such sums as may be
necessary for each of fiscal years 2010 through 2014.
6.Genomics
workforce and training
(a)Genetics and
genomics trainingThe Secretary, directly or through contracts or
grants to eligible entities, which shall include professional genetics and
genomics societies, academic institutions, and other entities as determined
appropriate by the Secretary, shall improve 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)develop and
disseminate model training program and residency curricula and teaching
materials that reflect the new knowledge and evolving practice of genetics and
genomics;
(2)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
(3)identify and
evaluate options for distance or on-line learning for degree or continuing
education programs.
(b)The
Secretary, in collaboration with medical professional societies and
accreditation bodies and associations of health professional schools, shall
support initiatives to increase the integration of genetics and genomics into
all aspects of clinical and public health practice by promoting genetics and
genomics competency across all clinical, public health, and laboratory
disciplines through the development and dissemination of health professional
guidelines which shall—
(1)include focus on
appropriate techniques for collection and storage of genomics samples,
administration and interpretation of genetic and genomic tests, and subsequent
clinical and public health decisionmaking; and
(2)specifically
target health professionals without formal training or experience in the field
of genomics.
(c)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section $10,000,000 for fiscal year 2009, and such sums as may be
necessary for each of fiscal years 2010 through 2014.
7.Realizing the
potential of personalized medicine
(a)Public registry
of information on validity of laboratory-developed genetic tests
(1)
(A)Section 520 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j) is amended by adding at the end the following:
(o)Registry on
analytical and clinical validity of laboratory-developed genetic tests
(1)The Secretary shall establish and maintain
a registry on the analytical and clinical validity of laboratory-developed
genetic tests.
(2)The registry under paragraph (1)
shall consist of information on the analytical and clinical validity of
laboratory-developed genetic tests submitted to the Secretary—
(A)under section 510(c), 515, or 520 for
clearance or approval of such tests (whether submitted before or after the date
of the enactment of this subsection); and
(B)under paragraph (3).
(3)(A)Unless a
laboratory-developed genetic test is cleared under section 510(k) or approved
under section 515 or 520(m) for its intended use, the manufacturer of the test
shall electronically submit to the Secretary information (in a form specified
by the Secretary and certified as truthful and accurate) on the analytical and
clinical validity of the test for its intended use.
(B)If the intended use of a
laboratory-developed genetic test is limited solely to the measurement of an
analytical property or characteristic, the manufacturer of the test shall not
submit any information with respect to the clinical validity of the test under
subparagraph (A) other than the following statement: This test is
intended to measure only the property or characteristic that is reported as a
result of use of the test. The test is not intended to be used to diagnose or
screen for any disease or condition, or to otherwise aid in decisionmaking with
respect to health, and this laboratory makes no representations as to its
usefulness for any such purpose.
.
(4)In this subsection:
(A)The term genetic test
means
an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that
detects genotypes, mutations, or chromosomal changes.
(B)The term laboratory-developed
genetic test
means a genetic test that is designed, validated,
conducted, and offered as a service by a clinical laboratory subject to section
353 of the Public Health Service Act (commonly referred to as the
Clinical Laboratory Improvement Amendments of 1988
) using either
commercially available analyte specific reagents (Food and Drug
Administration-regulated), reagents prepared by the laboratory (not Food and
Drug Administration-regulated), or some combination
thereof.
.
(B)Section 501 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351) is amended by adding at the end the following:
(j)If it is a laboratory-developed genetic
test described in section 520(o)(4) and the manufacturer of the test fails to
submit information with respect to the test as required by such
section.
.
(2)To inform implementation of the registry on
laboratory-developed genetic tests under section 520(o) of the Federal Food,
Drug, and Cosmetic Act, as added by paragraph (1), the Secretary shall
undertake a comparative analysis of laboratory review requirements under CLIA
and those of the Food and Drug Administration to—
(A)assess and reduce
unnecessary differences in such requirements;
(B)eliminate
redundancies and decrease the burden of review, as practicable; and
(C)specify which
elements of the test constitute a device that may be regulated by the Food and
Drug Administration and which elements comprise a service that may be regulated
under CLIA.
(3)Not later than 18 months after the date of
the enactment of this Act, the Secretary shall promulgate regulations to
implement the registry on laboratory-developed genetic tests under section
520(o) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph
(1).
(4)Effective date
of submission requirementsThe Secretary may not require a
laboratory to submit information under section 520(o) of the Federal Food, Drug
and Cosmetic Act, as added by paragraph (1), until the date that is 180 days
after the regulations promulgated pursuant to paragraph (3) take effect.
(5)The Secretary, acting through the Commissioner of Food and
Drugs and the Administrator of the Centers for Medicare & Medicaid
Services, shall—
(A)facilitate the use
of genetic and genomic approaches, as feasible, to assess risk for, and reduce
incidence of, adverse drug reactions;
(B)develop or expand
adverse event reporting systems to encompass reports of adverse events
resulting from genetic testing; and
(C)respond
appropriately to any adverse events resulting from such testing.
(b)National academy
of sciences studyNot later than 180 days after the date of the
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—
(1)codevelopment of
companion diagnostic testing by a drug sponsor;
(2)development of
companion diagnostic testing for already-approved drugs by the drug
sponsor;
(3)companion
diagnostic test development by device companies that are not affiliated with
the drug sponsor; and
(4)action on other
issues determined appropriate by the Secretary.
(c)Food and Drug
Administration
(1)Encouragement of
companion diagnostic testingThe Secretary, acting through the
Commissioner of Food and Drugs, may encourage 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.
(2)Pharmacogenomic
data submissionThe Secretary, acting through the Commissioner of
Food and Drugs, 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.
(3)Termination of
certain advertising campaignsThe Commissioner of Food and Drugs
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 the benefits or risks of genetic tests.
(d)Centers for
Medicare & Medicaid ServicesTo foster adoption of genetic
screening tools, the Administrator of the Centers for Medicare & Medicaid
Services shall—
(1)assess and update
current procedure terminology codes to encourage the rapid review and coverage
of novel tests through the creation of new Healthcare Common Procedures Coding
System (HCPCS
) codes and adoption of new current procedural
terminology (CPT
) codes and without undue reliance on national
coverage determinations; and
(2)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
marketingNot later than 2 years after the date of the enactment
of this Act, the Director of the Centers for Disease Control and Prevention (in
this subsection referred to as the Director
), with respect to
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 to determine whether
such claims are substantiated by competent and reliable scientific evidence;
and
(C)make
recommendations to the Secretary regarding necessary interventions to protect
the public from potential harms of direct to-consumer marketing and access to
genetic tests.
(2)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.
(f)Agency for
Healthcare Research and QualityThe Director of the Agency for
Healthcare Research and Quality, after consultation with the IWG and other
public and private organizations based in the United States and abroad, 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 clinical utility and
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)supports and
expedites the development of clinical decision tools for clinical use of
genetic tests, as warranted; 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
(1)To carry out
subsections (a), (c), (d), and (f), there are authorized to be appropriated
$30,000,000 for fiscal year 2009, and such sums as may be necessary for each of
fiscal years 2010 through 2014.
(2)Registry on
analytical and clinical validity of laboratory-developed genetic tests; adverse
event reportingTo carry out
subsection (b), there are authorized to be appropriated $10,000,000 for fiscal
year 2009, and such sums as may be necessary for each of fiscal years 2010
through 2014.
(3)CDC public
awareness activitiesTo carry out subsection (e), there are
authorized to be appropriated $30,000,000 for fiscal year 2009, and such sums
as may be necessary for each of fiscal years 2010 through 2014.
8.Tax credit for
research and development related to companion diagnostic tests
(a)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:
45Q.Companion
diagnostic test credit
(a)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)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 testFor 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 expensesFor purposes of this section, the term
qualified research expenses
has the meaning given to such term
under section 41(b).
(e)
(1)Coordination
with other deductions and creditsExcept 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 the credit under subsection
(a) attributable to such expense.
(2)Research and
development costs
(A)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 expensesAny 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)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)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 the enactment of this
section.
.
(b)Credit treated as
part of general business creditSection 38(b) of the Internal
Revenue Code of 1986 is amended by striking plus
at the end of
paragraph (32), by striking the period at the end of paragraph (33) and
inserting , plus
, and by adding at the end the following new
paragraph:
(34)the companion
diagnostic test credit determined under section
45Q(a).
.
(c)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. 45Q. Companion diagnostic test
credit.
.
(d)The amendments made by this section shall apply to expenses
paid or incurred in taxable years beginning after the date of the enactment of
this Act.