[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>