[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6498 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 6498

  To secure the promise of personalized medicine for all Americans by 
expanding and accelerating genomics research and initiatives to improve 
 the accuracy of disease diagnosis, increase the safety of drugs, and 
           identify novel treatments, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 15, 2008

 Mr. Kennedy introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   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

_______________________________________________________________________

                                 A BILL


 
  To secure the promise of personalized medicine for all Americans by 
expanding and accelerating genomics research and initiatives to improve 
 the accuracy of disease diagnosis, increase the safety of drugs, and 
           identify novel treatments, and for other purposes.

    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 2008''.

SEC. 2. FINDINGS.

    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.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Biobank.--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) Biomarker.--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) CLIA.--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) Environment.--The term ``environment'' means conditions 
        or circumstances that are nongenetic but may have a health 
        impact.
            (5) Genetic test.--The term ``genetic test'' means an 
        analysis of human DNA, RNA, chromosomes, proteins, or 
        metabolites, that detects genotypes, mutations, or chromosomal 
        changes.
            (6) IWG.--The term ``IWG'' means the Genomics and 
        Personalized Medicine Interagency Working Group established 
        pursuant to section 4.
            (7) Pharmacogenetic test.--
                    (A) In general.--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 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.
            (8) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 4. GENOMICS AND PERSONALIZED MEDICINE INTER AGENCY WORKING GROUP.

    (a) In General.--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) Duties.--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) IWG Chairperson.--The Secretary, or his or her designee, shall 
serve as chairperson of the IWG.
    (d) Members.--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) Public Input.--The IWG shall solicit input from relevant 
stakeholders with respect to meeting the duties described in subsection 
(b).
    (f) Report.--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) Termination.--The IWG shall terminate after submitting the 
report described in subsection (f), or later at the discretion of the 
Secretary.
    (h) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $5,000,000 for each of fiscal 
years 2009 and 2010.

SEC. 5. EXPANSION AND ACCELERATION OF GENETIC AND GENOMICS RESEARCH.

    (a) Genetics and Genomics Research.--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--
            (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) In general.--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) Database.--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) Rule of construction.--Nothing in this subsection shall 
        be construed to require the submission or acceptance of 
        biological specimens.
    (c) Biobank Initiatives Grants.--
            (1) In general.--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) Eligible entities.--
                    (A) In general.--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) Priority.--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) Requirements.--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) Use of funds.--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) Quality assurance.--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 Rules.--Nothing 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 Appropriations.--There 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.

SEC. 6. GENOMICS WORKFORCE AND TRAINING.

    (a) Genetics and Genomics Training.--The 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) Integration.--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 Appropriations.--There 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.

SEC. 7. REALIZING THE POTENTIAL OF PERSONALIZED MEDICINE.

    (a) Public Registry of Information on Validity of Laboratory-
Developed Genetic Tests.--
            (1) Registry.--
                    (A) In general.--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) Conforming amendment.--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) Comparative analysis.--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) Regulations.--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 requirements.--The 
        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) Adverse events.--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 Study.--Not 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 testing.--The 
        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 submission.--The 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 campaigns.--The 
        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 Services.--To 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 marketing.--Not 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) 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.
    (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 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) In general.--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 reporting.--
        To 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 activities.--To 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.

SEC. 8. 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. 45Q. 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 
        the credit under subsection (a) 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 the 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 
``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) 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. 45Q. Companion diagnostic test credit.''.
    (d) Effective Date.--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.
                                 <all>