II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Genomics and Person5 alized Medicine Act of 2006’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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1 (1) The completion of the Human Genome 

2 Project in 2003 paved the way for a more sophisti3 cated understanding of disease causation, which has 

4 contributed to the advent of ‘‘personalized medi5 cine’’. 

6 (2) Personalized medicine is the application of 

7 genomic and molecular data to better target the de8 livery of health care, facilitate the discovery and clin9 ical testing of new products, and help determine a 

10 patient’s predisposition to a particular disease or 

11 condition. 

12 (3) Many commonly-used drugs are typically ef13 fective in only 40 to 60 percent of the patient popu14 lation. 

15 (4) In the United States, up to 15 percent of 

16 hospitalized patients experience a serious adverse 

17 drug reaction, and more than 100,000 deaths are at18 tributed annually to such reactions. 

19 (5) Pharmacogenomics has the potential to dra20 matically increase the efficacy and safety of drugs 

21 and reduce healthcare costs, and is fundamental to 

22 the practice of genome-based personalized medicine. 

23 (6) Pharmacogenomics is the study of how 

24 genes affect a person’s response to drugs. This rel25 atively new field combines pharmacology (the science 


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1 of drugs) and genomics (the study of genes and 

2 their functions) to develop effective, safe medications 

3 and dosing regimens that will be tailored to an indi4 vidual’s genetic makeup. 

5 (7) The cancer drug Gleevec was developed 

6 based on knowledge of the chromosomal 

7 translocation that causes chronic myelogenous leu8 kemia, which is characterized by an abnormal 

9 growth in the number of white blood cells. The mean 

10 5-year survival for affected patients who are treated 

11 with Gleevec is 95 percent, which contrasts to a 5- 

12 year survival of 50 percent for patients treated with 

13 older therapies. 

14 (8) The ERBB2 gene helps cells grow, divide 

15 and repair themselves. One in 4 breast cancers are 

16 characterized by too many copies of this gene, which 

17 causes uncontrolled and rapid tumor growth. 

18 Pharmacogenomics research led to both the develop19 ment of the test for this type of breast cancer as 

20 well as an effective biologic, Herceptin. 

21 (9) Warfarin, a blood thinner used to prevent 

22 the formation of life-threatening clots, significantly 

23 elevates patient risk for bleeding in the head or gas24 trointestinal tract, both of which are associated with 

25 increased rates of hospitalization, disability and 


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1 death. Pharmacogenomic researchers have identified 

2 and developed tests for genetic variants in the 

3 cytochrome P450 metabolizing enzyme (CYP2C9) 

4 and vitamin K epoxide reductase complex that in5 crease risk for these adverse events. By using a com6 panion diagnostic test for these two genes, physi7 cians can modify the dosing regimen and decrease 

8 the likelihood of adverse events. 

9 (10) Although the cancer drug 6- 

10 mercaptopurine (6–MP) cures 85 percent of children 

11 with acute lymphoblastic leukemia, historically, a 

12 significant number of patients would die inexplicably 

13 from the drug. Researchers later discovered that 1 

14 in 10 individuals has an under-active version of the 

15 metabolizing enzyme thiopurine methyltransferase 

16 (TPMT) and should receive only a fraction of the 

17 standard dose of purine drugs. Physicians now are 

18 able to screen for TPMT gene variants before ad19 ministering these drugs. 

20 (11) Research into the genetics of breast cancer 

21 identified two pivotal genes, BRCA1 and BRCA2, 

22 mutations in which correspond to a significantly in23 creased lifetime risk of developing breast and ovar24 ian cancer. Individuals in affected families or with 

25 specific risk factors may use genetic testing to idenVerDate Aug 31 2005 00:10 Aug 10, 2006 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3822.IS S3822

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1 tify whether they carry mutations in these genes and 

2 to inform their decisions about treatment options, 

3 including mastectomy and oophorectomy. 

4 (12) Realizing the promise of personalized med5 icine will require continued Federal leadership and 

6 agency collaboration, expansion and acceleration of 

7 genomics research, a capable genomics workforce, in8 centives to encourage development and collection of 

9 data on the analytic and clinical validity of genomic 

10 tests and therapies, and improved regulation over 

11 the quality of genetic tests, direct-to-consumer ad12 vertising and use of personal genomic information. 

13 SEC. 3. DEFINITIONS. 

14 In this Act: 

15 (1) BIOMARKER.—The term ‘‘biomarker’’ 

16 means an analyte found in a patient specimen that 

17 is objectively measured and evaluated as an indi18 cator of normal biologic processes, pathogenic proc19 esses, or pharmacologic responses to a therapeutic 

20 intervention. 

21 (2) LABORATORY-DEVELOPED GENETIC

22 TEST.—The term ‘‘laboratory-developed genetic 

23 test’’ means a molecular genetic test that is de24 signed, validated, conducted, and offered as a service 

25 by a clinical laboratory subject to the Clinical LabVerDate Aug 31 2005 00:10 Aug 10, 2006 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3822.IS S3822

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1 oratory Improvement Amendments (referred to in 

2 this Act as ‘‘CLIA’’) using either commercially avail3 able analyte specific reagents (FDA-regulated) or re4 agents prepared by the laboratory (not FDA-regu5 lated), or some combination thereof. 

6 (3) MOLECULAR GENETIC TEST.—The term 

7 ‘‘molecular genetic test’’ means an analysis of 

8 human DNA, RNA, chromosomes, proteins, or me9 tabolites, that detects genotypes, mutations, or chro10 mosomal and biochemical changes. 

11 (4) PHARMACOGENETIC TEST.—The term 

12 ‘‘pharmacogenetic test’’ means a molecular genetic 

13 test intended to identify individual variations in 

14 DNA sequence related to drug absorption and dis15 position (pharmacokinetics) or drug action 

16 (pharmacodynamics), including polymorphic vari17 ation in the genes that encode the functions of 

18 transporters, receptors, metabolizing enzymes, and 

19 other proteins. 

20 (5) PHARMACOGENOMIC TEST.— 

21 (A) IN GENERAL.—The term ‘‘pharmaco22 genomic test’’ means a molecular genetic test 

23 intended to identify individual variations in sin24 gle-nucleotide polymorphisms, haplotype mark25 ers, or alterations in gene expression or inacVerDate Aug 31 2005 00:10 Aug 10, 2006 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3822.IS S3822

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1 tivation, that may be correlated with pharma2 cological function and therapeutic response. 

3 (B) VARIATIONS AND ALTERATIONS.—For 

4 purposes of this paragraph, the variations or al5 terations referred to in subparagraph (A) may 

6 be a pattern or profile of change, rather than 

7 a change in an individual marker. 

8 (6) SECRETARY.—The term ‘‘Secretary’’ means 

9 the Secretary of Health and Human Services. 

10 SEC. 4. GENOMICS AND PERSONALIZED MEDICINE INTER11 AGENCY WORKING GROUP. 

12 (a) IN GENERAL.—The Secretary shall establish 

13 within the Department of Health and Human Services the 

14 Genomics and Personalized Medicine Interagency Working 

15 Group (referred to in this Act as the ‘‘IWG’’). 

16 (b) PURPOSE.—It shall be the purpose of the IWG 

17 to expand and accelerate genetics and genomics research, 

18 and the translation of findings from such research into 

19 clinical and public health application, by— 

20 (1)(A) enhancing communication about current 

21 and proposed activities and areas of focus by the 

22 Department of Health and Human Services and 

23 other relevant Federal departments and agencies, in24 cluding communication focused on findings and rec25 ommendations from— 


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1 (i) the advisory groups on genetics of the 

2 Secretary, including the Secretary’s Advisory 

3 Committee on Genetics, Health, and Society, 

4 and the Advisory Committee on Heritable Dis5 orders and Genetic Diseases in Newborns and 

6 Children; and 

7 (ii) the National Academies of Science, in8 cluding the Institute of Medicine; and 

9 (B) identifying areas of need and opportunity; 

10 and 

11 (2) facilitating collaboration, coordination, and 

12 integration of activities, within the Federal agencies, 

13 and among such agencies and their public and pri14 vate partners to leverage resources and avoid dupli15 cation of effort. 

16 (c) IWG CHAIRPERSON.—The Secretary shall serve 

17 as chairperson of the IWG. The Secretary may not des18 ignate another person to serve as a chairperson of the 

19 IWG. 

20 (d) MEMBERS.—In addition to the Secretary, the 

21 IWG shall include members from the— 

22 (1) National Institutes of Health, including the 

23 National Human Genome Research Institute, the 

24 National Institute of Environmental Health 

25 Sciences, the Department of Clinical Bioethics, and 


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1 the National Center on Minority Health and Health 

2 Disparities; 

3 (2) Centers for Disease Control and Prevention, 

4 including the Office of Genomics and Disease Pre5 vention; 

6 (3) Food and Drug Administration, including 

7 the Office of Clinical Pharmacology and Biopharma8 ceutics Review and the Office of In Vitro 

9 Diagnostics; 

10 (4) Health Resources and Services Administra11 tion, including the genetic services branch of the 

12 Maternal and Child Health Bureau and the Bureau 

13 of Health Professions; 

14 (5) Office of Minority Health; 

15 (6) Agency for Healthcare Research and Qual16 ity; 

17 (7) Centers for Medicare & Medicaid Services; 

18 (8) Veterans Health Administration; 

19 (9) Office of the National Coordinator for 

20 Health Information Technology; 

21 (10) Department of Energy, including the 

22 Human Genome Program and Joint Genome Insti23 tute of the Office of Science; and 

24 (11) other Federal departments and agencies as 

25 determined appropriate by the Secretaries. 


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1 (e) DUTIES OF THE IWG.—In fulfilling the purpose 

2 described in subsection (b), members of the IWG shall— 

3 (1) meet not less frequently than twice each 

4 year or at the call of the chairperson; 

5 (2) draft recommendations for various heads of 

6 Federal departments and agencies; and 

7 (3) provide opportunities for public input and 

8 comment on the deliberations and activities of the 

9 IWG, as appropriate. 

10 (f) REPORT.—Not later than 1 year after the date 

11 of enactment of this Act, and biennially thereafter, the 

12 Secretary shall report to the appropriate committees of 

13 Congress and to the public on IWG activities, with respect 

14 to meeting the purpose described in subsection (b) and 

15 carrying out the duties described in subsection (e). 

16 (g) AUTHORIZATION OF APPROPRIATIONS.—There is 

17 authorized to be appropriated to carry out this section, 

18 $5,000,000 for fiscal year 2007, and such sums as may 

19 be necessary for each of fiscal years 2008 through 2012. 

20 SEC. 5. EXPANSION AND ACCELERATION OF GENETIC AND 

21 GENOMICS RESEARCH. 

22 (a) GENETICS AND GENOMICS RESEARCH.— 

23 (1) IN GENERAL.—The Secretary shall expand 

24 and accelerate research and programs to collect ge25 netic and genomic data that will advance the field of 


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1 genomics and personalized medicine, with prioritized 

2 focus on— 

3 (A) studies of diseases and health condi4 tions with substantial public health impact; 

5 (B) population-based studies of genotype 

6 prevalence, gene-disease association, gene-drug 

7 response association, and gene-environment 

8 interactions; 

9 (C) systematic review and synthesis of the 

10 results of population-based studies using meth11 ods of human genome epidemiology; 

12 (D) translation of genomic information 

13 into molecular genetic screening tools, 

14 diagnostics, and therapeutics, through well-con15 ducted clinical trials and studies; 

16 (E) translation of genomic information 

17 into tools for public health investigations and 

18 ongoing biosurveillance and monitoring; 

19 (F) systematic review of data on analytic 

20 validity and clinical validity of molecular genetic 

21 tests; 

22 (G) comprehensive studies of clinical util23 ity, including cost-effectiveness and cost-benefit 

24 analyses, of molecular genetic tests and thera25 peutics; 


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1 (H) population based studies to assess the 

2 awareness, knowledge, and use of genetic tests 

3 and their impact on the population health and 

4 health disparities; and 

5 (I) methods to enhance provider uptake or 

6 adoption of pharmacogenomic products into 

7 practice. 

8 (2) BIOBANKING.— 

9 (A) NATIONAL BIOBANKING RESEARCH

10 INITIATIVE.—The Secretary, in collaboration 

11 with the IWG, shall develop a plan for a na12 tional biobanking research initiative that— 

13 (i) addresses priority areas of focus, 

14 as described in paragraph (1); 

15 (ii) builds upon current genomic re16 search initiatives (existing as of the date 

17 the plan is issued) domestically and, as 

18 practicable, internationally; 

19 (iii) is prospective and long-term in 

20 design; 

21 (iv) takes into consideration public re22 view and comment; 

23 (v) is designed to support collection 

24 and synthesis of evidence for public health 

25 and clinical applications; 


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1 (vi) meets rigorous standards and 

2 guidelines regarding ethics, legality, and 

3 social issues; 

4 (vii) ensures diverse representation of 

5 individuals in the research or data collec6 tion that would allow statistically signifi7 cant analyses of population subgroups as 

8 appropriate; and 

9 (viii) reflects public-private partner10 ship. 

11 (B) NATIONAL BIOBANKING DISTRIBUTED

12 DATABASE.— 

13 (i) IN GENERAL.—The Secretary, act14 ing through the Director of the National 

15 Human Genome Research Institute at the 

16 National Institutes of Health and the Di17 rector of the Office of Genomics and Dis18 ease Prevention at the Centers for Disease 

19 Control and Prevention, shall establish a 

20 system for the integration of data, includ21 ing genomic data and associated environ22 mental and clinical health information, 

23 which shall facilitate the pooled analysis 

24 and synthesis of such data. 


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1 (ii) DISTRIBUTED DATABASE.—With 

2 respect to such national biobanking data3 base, the Secretary shall— 

4 (I) establish a grant program for 

5 local or regional biobanking initia6 tives, in accordance with subpara7 graph (C), with priority given for local 

8 or regional biobanks that— 

9 (aa) are established or com10 plement activities related to the 

11 implementation of the national 

12 biobanking research initiative, 

13 pursuant to subparagraph (A); 

14 (bb) are based on well-de15 fined populations, such as co16 horts of newborn infants 

17 screened by State health depart18 ments for metabolic disorders, 

19 population-based registries of 

20 cancer and other diseases, and 

21 family-based registries; 

22 (cc) collect data from par23 ticipants with diverse genetic pro24 files, environmental exposures, 


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1 and health conditions and dis2 eases; and 

3 (dd) participate in and con4 tribute data to consortia estab5 lished to develop and apply best 

6 practices and standards in the re7 search area of such consortium; 

8 (II) assist in the development of 

9 uniform standards and guidelines for 

10 the collection, submission, and storage 

11 of biobank data; 

12 (III) develop and promulgate 

13 guidelines regarding procedures, pro14 tocols, and policies for access of data 

15 by non-governmental entities and the 

16 safeguarding of the privacy of biobank 

17 subjects, in accordance with the Office 

18 for Human Research Protection and 

19 Clinical Research Policy Analysis and 

20 Coordination program at the National 

21 Institutes of Health, and other guide22 lines as appropriate; 

23 (IV) review and make rec24 ommendations to address ownership 


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1 issues with respect to genomic sam2 ples and analyses; 

3 (V) encourage voluntary submis4 sion of biobanking data obtained or 

5 analyzed with private or non-Federal 

6 funds; 

7 (VI) facilitate submission of data, 

8 including secure and efficient elec9 tronic submission; 

10 (VII) incorporate data from Fed11 eral surveys, such as the National 

12 Health and Nutrition Examination 

13 Survey; 

14 (VIII) develop and disseminate 

15 standard consent forms, including 

16 those that allow multiple uses of data 

17 for research purposes; 

18 (IX) conduct, directly or by con19 tract, analytical research, including 

20 clinical, epidemiological, and social re21 search, using biobank data; 

22 (X) allow public use of data 

23 only— 

24 (aa) with appropriate pri25 vacy safeguards in place; and 


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1 (bb) for health research pur2 poses; 

3 (XI) determine appropriate pro4 cedures for industry access to biobank 

5 data for research and development of 

6 new or improved tests and treatments, 

7 and submission of data generated 

8 from such samples to the Food and 

9 Drug Administration as part of the 

10 approval process for drugs and de11 vices; and 

12 (XII) make analytic findings 

13 from biobanking initiatives supported 

14 by Federal funding publicly available 

15 within an appropriate timeframe to be 

16 determined by the Secretary, which 

17 findings shall not contain identifiable 

18 information of patients. 

19 (iii) NATIONAL RESOURCES.—The 

20 IWG shall sponsor national efforts to bring 

21 together the consortia described in clause 

22 (ii)(I)(dd) to build national data resources. 

23 (C) BIOBANK INITIATIVES GRANTS.— 

24 (i) IN GENERAL.—The Secretary shall 

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1 tutions to enable the institutions to develop 

2 or expand biobanking initiatives to advance 

3 the application of genomics to the practice 

4 of medicine and contribute to the under5 standing of the genetic causes of disease. 

6 (ii) ELIGIBILITY.—An academic med7 ical center or other institution shall be eli8 gible for a grant under this subparagraph 

9 if the center or institution has— 

10 (I) practical experience and dem11 onstrated expertise in genomics and 

12 its clinical and public health applica13 tions; 

14 (II) an established scientific advi15 sory committee to— 

16 (aa) advise staff on genomic 

17 issues, including related ethical, 

18 legal, and social issues; 

19 (bb) evaluate and approve 

20 research studies utilizing the 

21 biobank data; and 

22 (cc) provide a forum for evi23 dence-based reviews and integra24 tion of research findings to deter25 mine if and how such findings 


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1 may be used in health care and 

2 disease prevention; 

3 (III) an established community 

4 advisory committee comprised of com5 munity advocates, potential study par6 ticipants, and other stakeholders, to— 

7 (aa) provide a non-scientific 

8 perspective on the biobanking ini9 tiative; 

10 (bb) guide the development 

11 of patient-oriented materials; 

12 (cc) support outreach to mi13 nority and other underserved 

14 communities; and 

15 (dd) provide a forum for the 

16 discussion of ethical, social, and 

17 legal issues pertaining to the bio18 banking initiative; 

19 (IV) mechanisms to ensure pa20 tient privacy and protection of infor21 mation from non-health applications; 

22 and 

23 (V) a demonstrated ability to re24 cruit patients from diverse cultural 

25 backgrounds. 


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1 (iii) USE OF FUNDS.—An eligible in2 stitution that receives a grant under this 

3 subparagraph shall use the grant funds to 

4 develop or expand a biobanking initiative, 

5 which may include the following activities: 

6 (I) Support for advisory commit7 tees. 

8 (II) Recruitment and education 

9 of patients. 

10 (III) Development of consent 

11 protocols. 

12 (IV) Obtaining genetic samples 

13 and clinical information. 

14 (V) Establishment and mainte15 nance of secure storage for genetic 

16 samples and clinical information. 

17 (VI) Conduct of data analyses 

18 and evidence-based systemic reviews 

19 that allow for the following: 

20 (aa) Identification of bio21 markers and other surrogate 

22 markers to improve predictions of 

23 onset of disease, response to 

24 therapy, and clinical outcomes. 


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1 (bb) Increased under2 standing of gene-environment 

3 interactions. 

4 (cc) Development of molec5 ular genetic screening, diagnostic, 

6 and therapeutic interventions. 

7 (dd) Genotypic characteriza8 tion of tissue samples. 

9 (VII) Support for participation in 

10 research consortia concerned with es11 tablishing and developing best prac12 tices and standards in the relevant re13 search areas. 

14 (VIII) Development and imple15 mentation of protocols for external re16 searchers to access non-identifiable 

17 patient samples and associated health 

18 information for research activities. 

19 (IX) Other activities, as deter20 mined appropriate by the Secretary. 

21 (b) RACE, GENOMICS, AND HEALTH.— 

22 (1) IN GENERAL.—The Secretary shall expand 

23 and intensify efforts to increase knowledge about 

24 the— 


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1 (A) interaction between genetics and the 

2 environment, and the influence of such inter3 action on the causality and treatment of dis4 eases common in racial and ethnic minority 

5 populations; and 

6 (B) ways in which molecular genetic 

7 screening, diagnostics, and treatments may be 

8 used to improve the health and health care of 

9 racial and ethnic minority populations. 

10 (2) RACE AND GENOMICS.—Not later than 1 

11 year after the date of enactment of this Act, the 

12 Secretary, in collaboration with the IWG, shall pre13 pare, with public input, and publish trans-agency 

14 guidance regarding the following: 

15 (A) An appropriate definition for race and 

16 ethnicity for use in genomic research and pro17 grams operated or supported by the Federal 

18 Government. 

19 (B) Guiding ethics, principles, and proto20 cols for the inclusion and designation of racial 

21 and ethnic populations in genomics research 

22 and programs operated or supported by the 

23 Federal Government. 


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1 (C) Ways to increase access to effective 

2 pharmacogenomic and other clinical genetic 

3 services for minority populations. 

4 (D) Research opportunities and funding 

5 support in the area of race and genomics that 

6 may improve the health and health care of mi7 nority populations. 

8 (E) Ways to enhance integration of Fed9 eral Government-wide efforts and activities per10 taining to race, genomics, and health. 

11 (F) Any needs for additional privacy pro12 tections in preventing stigmatization and inap13 propriate use of genetic information. 

14 (c) AUTHORIZATION OF APPROPRIATIONS.—There is 

15 authorized to be appropriated to carry out this section, 

16 $150,000,000 for fiscal year 2007, and such sums as may 

17 be necessary for each of fiscal years 2008 through 2012. 

18 SEC. 6. GENOMICS WORKFORCE AND TRAINING. 

19 (a) IN GENERAL.—The Secretary, acting through the 

20 Administrator of the Health Resources and Services Ad21 ministration and the Director of the Centers for Disease 

22 Control and Prevention, and in collaboration with the 

23 IWG, shall expand and intensify efforts to— 


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1 (1) support efforts to recruit and retain health 

2 professionals from diverse backgrounds in the 

3 genomics workforce; 

4 (2) in collaboration with appropriate profes5 sional accreditation organizations, assess and make 

6 recommendations to improve the quality of genomics 

7 training; and 

8 (3) develop a plan to integrate genomics into all 

9 aspects of health professional training. 

10 (b) ELIGIBLE ENTITY.—For purposes of this section, 

11 the term ‘‘eligible entity’’ includes professional genetics 

12 and genomics societies and academic institutions deter13 mined appropriate by the Secretary. 

14 (c) RECRUITMENT AND RETENTION.—The Secretary 

15 shall provide financial and technical support to eligible en16 tities to increase recruitment and retention of trainees in 

17 genetics and genomics by— 

18 (1) providing education and awareness opportu19 nities, practical and research experiences, and finan20 cial incentives such as scholarships or loan repay21 ment; 

22 (2) considering development of genomic sub23 specialty fellowships or concentrations within genet24 ics training programs; 


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1 (3) considering development of combined resi2 dency programs or joint subspecialty fellowships 

3 with other specialties; 

4 (4) providing support for laboratory-based ge5 netics or genomics fellowships for medical and other 

6 health professional students; and 

7 (5) carrying out other activities determined ap8 propriate by the Secretary. 

9 (d) GENETICS AND GENOMICS TRAINING.—The Sec10 retary, directly or through contracts or grants to eligible 

11 entities, shall ensure the adequacy of genetics and 

12 genomics training for diagnosis, treatment, and counseling 

13 of adults and children for both rare and common dis14 orders, through support of efforts to— 

15 (1) strengthen the core training content of the 

16 various clinical disciplines to reflect new knowledge 

17 and evolving practice of genetics and genomics; 

18 (2) develop and disseminate model residency 

19 and other training program curricula and teaching 

20 materials that integrate and broaden the base of 

21 medical genetics and genomics training; 

22 (3) assist the review of board and other certi23 fying examinations by professional societies and ac24 creditation bodies to ensure adequate focus on the 

25 fundamental principles of genomics; and 


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1 (4) explore options for distance or on-line learn2 ing for degree or continuing education programs. 

3 (e) INTEGRATION.—The Secretary shall support ini4 tiatives to increase the integration of genetics and 

5 genomics into all aspects of clinical and public health prac6 tice by— 

7 (1) generating greater awareness of the rel8 evance and application of genetics and genomics to 

9 common disorders; and 

10 (2) promoting genetics and genomics com11 petency across all clinical, public health and labora12 tory disciplines through the development and dis13 semination of health professional guidelines which 

14 shall— 

15 (A) include focus on appropriate adminis16 tration and interpretation of genomic tests, and 

17 subsequent clinical and public health decision18 making; and 

19 (B) specifically target health professionals 

20 without formal training or experience in the 

21 field of genomics. 

22 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

23 are authorized to be appropriated to carry out this section 

24 $10,000,000 for fiscal year 2007 and such sums as may 

25 be necessary for each of fiscal years 2008 through 2012. 


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1 SEC. 7. REALIZING THE POTENTIAL OF PERSONALIZED 

2 MEDICINE. 

3 (a) INCENTIVES.— 

4 (1) TAX CREDIT FOR RESEARCH AND DEVELOP5 MENT RELATED TO COMPANION DIAGNOSTIC

6 TESTS.— 

7 (A) IN GENERAL.—Subpart D of part IV 

8 of subchapter A of chapter 1 of the Internal 

9 Revenue Code of 1986 is amended by adding at 

10 the end the following new section: 

11 ‘‘SEC. 45N. COMPANION DIAGNOSTIC TEST CREDIT. 

12 ‘‘(a) ALLOWANCE OF CREDIT.—For purposes of sec13 tion 38, in the case of an eligible taxpayer, the companion 

14 diagnostic test credit for any taxable year is an amount 

15 equal to the qualified research expenses paid or incurred 

16 by the taxpayer during the taxable year in connection with 

17 the development of a qualified companion diagnostic test 

18 . 

19 ‘‘(b) ELIGIBLE TAXPAYER.—For purposes of this 

20 section, the term ‘eligible taxpayer’ means a taxpayer who 

21 has been requested to develop a qualified companion diag22 nostic test by the Secretary of Health and Human Serv23 ices in connection with a drug— 

24 ‘‘(1) for which an application has been sub25 mitted under section 501(b)(1) of the Federal Food, 

26 Drug, and Cosmetic Act, or 


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1 ‘‘(2) for which an application has been ap2 proved under such section. 

3 ‘‘(c) QUALIFIED COMPANION DIAGNOSTIC TEST.— 

4 For purposes of this section, the term ‘qualified com5 panion diagnostic test’ means a diagnostic test in connec6 tion with a drug which— 

7 ‘‘(1) is designed to provide information which 

8 can be used to increase the safety or effectiveness of 

9 the drug, and 

10 ‘‘(2) is approved by the Secretary of Health and 

11 Human Services. 

12 ‘‘(d) QUALIFIED RESEARCH EXPENSES.—For pur13 poses of this section, the term ‘qualified research expenses’ 

14 has the meaning given to such term under section 41(b). 

15 ‘‘(e) NO DOUBLE BENEFIT.— 

16 ‘‘(1) COORDINATION WITH OTHER DEDUCTIONS

17 AND CREDITS.—Except as provided in paragraph 

18 (2), the amount of any deduction or other credit al19 lowable under this chapter for any expense taken 

20 into account in determining the amount of the credit 

21 under subsection (a) shall be reduced by the amount 

22 of such credit attributable to such expense. 

23 ‘‘(2) RESEARCH AND DEVELOPMENT COSTS.— 

24 ‘‘(A) IN GENERAL.—Except as provided in 

25 subparagraph (B), any amount which is taken 


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1 into account in determining the amount of the 

2 credit under subsection (a) for any taxable year 

3 shall not be taken into account for purposes of 

4 determining the credit under section 41 for 

5 such taxable year. 

6 ‘‘(B) COSTS TAKEN INTO ACCOUNT IN DE7 TERMINING BASE PERIOD RESEARCH EX8 PENSES.—Any amount taken into account in 

9 determining the amount of the credit under 

10 subsection (a) for any taxable year shall be 

11 taken into account in determining base period 

12 research expenses for purposes of applying sec13 tion 41 to subsequent taxable years. 

14 ‘‘(f) REGULATIONS.—The Secretary, in consultation 

15 with the Secretary of Health and Human Services, shall 

16 promulgate such regulations as are necessary to carry out 

17 the purposes of this section. 

18 ‘‘(g) TERMINATION.—This section shall not apply to 

19 expenses paid or incurred in taxable years beginning after 

20 the date which is 5 years after the date of enactment of 

21 this section.’’. 

22 (B) CREDIT TREATED AS PART OF GEN23 ERAL BUSINESS CREDIT.—Section 38(b) of the 

24 Internal Revenue Code of 1986 is amended by 

25 striking ‘‘and’’ at the end of paragraph (29), by 


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1 striking the period at the end of paragraph (30) 

2 and inserting ‘‘, plus’’, and by adding at the 

3 end the following new paragraph: 

4 ‘‘(31) the companion diagnostic test credit de5 termined under section 45N(a).’’. 

6 (C) CLERICAL AMENDMENT.—The table of 

7 sections for subpart D of subchapter A of chap8 ter 1 of the Internal Revenue Code of 1986 is 

9 amended by adding at the end the following 

10 new item: 

‘‘Sec. 45N. Companion diagnostic test credit.’’. 

11 (D) EFFECTIVE DATE.—The amendments 

12 made by this paragraph shall apply to expenses 

13 paid or incurred in taxable years beginning 

14 after the date of enactment of this Act. 

15 (2) NATIONAL ACADEMY OF SCIENCES

16 STUDY.—Not later than 6 months after the date of 

17 enactment of this Act, the Secretary shall enter into 

18 a contract with the National Research Council of the 

19 National Academy of Sciences to study and rec20 ommend appropriate incentives to encourage— 

21 (A) co-development of companion diag22 nostic testing by a drug sponsor; 

23 (B) development of companion diagnostic 

24 testing for already-approved drugs by the drug 

25 sponsor; 


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1 (C) companion diagnostic test development 

2 by device companies that are not affiliated with 

3 the drug sponsor; and 

4 (D) action on other issues determined ap5 propriate by the Secretary. 

6 (b) GENETIC TEST QUALITY.— 

7 (1) IN GENERAL.—The Secretary shall improve 

8 the safety, efficacy, and availability of information 

9 about genetic tests, including pharmacogenetic and 

10 pharmacogenomic tests. 

11 (2) INSTITUTE OF MEDICINE STUDY.—Not later 

12 than 30 days after the date of enactment of this 

13 Act, the Secretary shall enter into a contract with 

14 the Institute of Medicine to conduct a study and a 

15 prepare a report that includes recommendations to 

16 improve Federal oversight and regulation of genetic 

17 tests, with specific recommendations on the develop18 ment of the decision matrix under paragraph (3). 

19 Such study shall be completed not later than 1 year 

20 after the date on which such contract was entered 

21 into. 

22 (3) DECISION MATRIX.— 

23 (A) IN GENERAL.—The Secretary, taking 

24 into consideration the recommendations of the 

25 Institute of Medicine report under paragraph 


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1 (2), shall develop a decision matrix (referred to 

2 in this section as the ‘‘matrix’’) to improve the 

3 oversight and regulation of genetic tests, includ4 ing pharmacogenomics and pharmacogenetic 

5 tests by— 

6 (i) determining the classification of 

7 genetic tests that have not yet been classi8 fied, or of which the classification is un9 clear, questioned, or challenged; 

10 (ii) determining which types of tests, 

11 including laboratory-developed tests, re12 quire review and the level of review needed 

13 for such tests; 

14 (iii) determining which agency shall 

15 have oversight over the review process of 

16 such tests that are determined to require 

17 review; and 

18 (iv) determining, to the extent prac19 ticable, which requirements the agency 

20 shall apply to the types of tests identified 

21 in clause (ii). 

22 (B) LEVEL OF REVIEW.—In determining 

23 the level of review needed by a genetic test, the 

24 Secretary shall take into consideration— 


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1 (i) characteristics of the test and its 

2 target disease or condition; 

3 (ii) intended use of the test; 

4 (iii) potential for improved medical 

5 conditions and patient harms; and 

6 (iv) social consequences of the test. 

7 (C) COMPARATIVE ANALYSIS.—To inform 

8 development of the matrix, the Secretary shall 

9 undertake a comparative analysis of laboratory 

10 review requirements under the Clinical Labora11 tory Improvement Act and those of the Food 

12 and Drug Administration to assess and reduce 

13 differences in such requirements, and to elimi14 nate redundancies and decrease burden of re15 view, as practicable. 

16 (D) REGULATIONS.—Not later than 30 

17 months after the date of enactment of this Act, 

18 the Secretary shall promulgate regulations to 

19 implement the matrix. 

20 (4) ADVERSE EVENTS.—The Secretary, acting 

21 through the Commissioner of Food and Drugs and 

22 the Administrator of the Centers for Medicare & 

23 Medicaid Services, shall— 


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1 (A) develop or expand adverse event re2 porting systems to encompass reports of ad3 verse events resulting from genetic testing; and 

4 (B) respond appropriately to any adverse 

5 events resulting from such testing. 

6 (5) AUTHORIZATION OF APPROPRIATIONS.— 

7 There is authorized to be appropriated to carry out 

8 this subsection, $10,000,000 for fiscal year 2007, 

9 and such sums as may be necessary for each of fis10 cal years 2008 through 2012. 

11 (c) FOOD AND DRUG ADMINISTRATION.— 

12 (1) IN GENERAL.— 

13 (A) SUMMARY INFORMATION.—If a genetic 

14 test that is determined to be within the jurisdic15 tion of the Food and Drug Administration but 

16 that does not require review, as determined 

17 under the matrix, the sponsor of such test shall 

18 provide the Secretary with summary informa19 tion on how the test was validated and its per20 formance characteristics, which information 

21 shall be made easily accessible for the public. 

22 (B) SOURCE OF INFORMATION.—The in23 formation described under subparagraph (A) 

24 may be obtained from the labeling submitted 

25 for CLIA complexity categorization. 


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1 (2) REQUIREMENT FOR COMPANION DIAG2 NOSTIC TESTING.—The Secretary may require the 

3 sponsor of a drug or biological product— 

4 (A) to codevelop a companion diagnostic 

5 test, after filing an investigational new drug ap6 plication or a new drug application to address 

7 significant safety concerns of the drug or bio8 logical product; 

9 (B) to develop a companion diagnostic test 

10 if phase IV data demonstrate significant safety 

11 or effectiveness concerns with use of the drug 

12 or biological product; and 

13 (C) to relabel the drug or biological prod14 uct to require validated companion diagnostic 

15 testing when evidence of improved outcomes has 

16 been established in practice or if data dem17 onstrate significant safety concerns with use of 

18 such drug or biological product. 

19 (3) PHARMACOGENOMIC DATA SUBMISSION.— 

20 The Secretary shall encourage and facilitate vol21 untary pharmacogenomic data submission from drug 

22 sponsors, which may include— 

23 (A) the development and dissemination of 

24 guidance on relevant policies, procedure and 

25 practice regarding such submission; 


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1 (B) the provision of technical assistance; 

2 (C) the establishment of a mechanism to 

3 store, maintain and analyze such data, in col4 laboration with the National Institutes of 

5 Health and the Centers for Disease Control and 

6 Prevention; 

7 (D) determining when such data may be 

8 used to support an investigational new drug or 

9 a new drug application; 

10 (E) the conduct of a study of the use of 

11 genomic approaches to understand and reduce 

12 adverse drug reactions; and 

13 (F) other activities determined appropriate 

14 by the Commissioner. 

15 (4) LABELING FOR CERTAIN GROUPS.—Not 

16 later than 6 months of enactment of this Act, the 

17 Secretary shall prepare and publish guidance regard18 ing the approval, licensing, or clearance of any prod19 uct under the Federal Food, Drug and Cosmetic Act 

20 (21 U.S.C. 301 et seq.) or section 351 of the Public 

21 Health Service Act (42 U.S.C. 262) with an indica22 tion, contraindication, warning, or any other labeling 

23 information that is specific to a racial or ethnic 

24 group. 


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1 (5) TERMINATION OF CERTAIN ADVERTISING

2 CAMPAIGNS.—The Food and Drug Administration 

3 shall collaborate with the Federal Trade Commission 

4 to identify and terminate, pursuant to section 5 of 

5 the Federal Trade Commission Act (15 U.S.C. 45), 

6 advertising campaigns that make false, misleading, 

7 deceptive, or unfair claims about molecular genetic 

8 tests. 

9 (d) CENTERS FOR MEDICARE & MEDICAID SERV10 ICES.— 

11 (1) IN GENERAL.—If a genetic test that is de12 termined to be within the jurisdiction of the Centers 

13 for Medicare & Medicaid Services does not require 

14 review as determined under the matrix, the sponsor 

15 of such test shall provide the Administrator of the 

16 Centers for Medicare & Medicaid Services with sum17 mary information on how the test was validated and 

18 its performance characteristics, which information 

19 shall be made easily accessible for the public. 

20 (2) SPECIALTY AREA.—To ensure the accuracy, 

21 validity, and reliability of clinical genetic tests that 

22 do not require premarket approval by or notification 

23 to the Food and Drug Administration, and to im24 prove oversight of genetic test laboratories, the Di25 rector of the Division of Laboratory Services of the 


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1 Survey and Certification Group of the Center for 

2 Medicaid and State Operations of the Centers for 

3 Medicare & Medicaid Services, in collaboration with 

4 the Clinical Laboratory Improvement Advisory Com5 mittee at the Centers for Disease Control and Pre6 vention, shall establish a specialty area for molecular 

7 and biochemical genetic tests, in order to— 

8 (A) develop criteria for establishing ana9 lytic and clinical validity for genetic tests that 

10 are determined to require review under the ma11 trix; 

12 (B) specify requirements for proficiency 

13 testing for laboratories; 

14 (C) provide guidance regarding the scope 

15 of duty for laboratory directors; 

16 (D) make information easily accessible to 

17 the public about— 

18 (i) laboratory certification; and 

19 (ii) analytic and clinical validity for 

20 genetic tests that are determined to require 

21 high level review under the matrix; and 

22 (E) conduct other activities at the discre23 tion of the Administrator of the Centers for 

24 Medicare & Medicaid Services. 


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1 (3) REIMBURSEMENT.—To foster adoption of 

2 molecular genetic screening tools, the Administrator 

3 of the Centers for Medicare & Medicaid Services 

4 shall— 

5 (A) assess and update current procedure 

6 terminology codes as warranted; and 

7 (B) determine and implement fair and rea8 sonable coverage policies and reimbursement 

9 rates for medically necessary genetic and 

10 genomic treatments and services, including lab11 oratory testing. 

12 (e) CENTERS FOR DISEASE CONTROL AND PREVEN13 TION.— 

14 (1) DIRECT-TO-CONSUMER MARKETING.—Not 

15 later than 12 months after the date of enactment of 

16 this Act, the Director of the Centers for Disease 

17 Control and Prevention, with respect to molecular 

18 genetic tests for which consumers have direct access, 

19 shall— 

20 (A) conduct an analysis of the public 

21 health impact of direct-to-consumer marketing 

22 to the extent possible from available data 

23 sources; 

24 (B) analyze the validity of claims made in 

25 direct-to-consumer marketing; and 


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1 (C) make recommendations to Congress re2 garding necessary interventions to protect the 

3 public from potential harms of direct-to-con4 sumer marketing and access to molecular ge5 netic tests. 

6 (2) PUBLIC AWARENESS.—The Director shall 

7 expand efforts to educate and increase awareness of 

8 the general public about genomics and its applica9 tions to improve health, prevent disease and elimi10 nate health disparities. Such efforts shall include 

11 the— 

12 (A) ongoing collection of data on the 

13 awareness, knowledge and use of genetic tests 

14 through public health surveillance systems, and 

15 analysis of the impact of such tests on popu16 lation health; and 

17 (B) integration of the use of validated ge18 netic and genomic tests in public health pro19 grams as appropriate. 

20 (3) AUTHORIZATION OF APPROPRIATIONS.— 

21 There is authorized to be appropriated to carry out 

22 this subsection, $30,000,000 for fiscal year 2007, 

23 and such sums as may be necessary for each of fis24 cal years 2008 through 2012. 


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1 (f) AGENCY FOR HEALTHCARE RESEARCH AND

2 QUALITY.—The Director of the Agency for Healthcare 

3 Research and Quality, after consultation with the IWG 

4 and other public and private organizations, as appropriate, 

5 shall support the assessment of the clinical utility and 

6 cost-effectiveness of companion diagnostic tests that guide 

7 prescribing decisions, through research that— 

8 (1) develops standardized tools and methodolo9 gies to assess the cost-effectiveness of such tests, as 

10 well as criteria for use; 

11 (2) establishes and validates drug dosing algo12 rithms for which such tests can improve outcomes, 

13 taking into consideration— 

14 (A) a reduction in toxicity, adverse events, 

15 and mortality; 

16 (B) improved clinical outcomes and quality 

17 of life, including decreased requirements for 

18 monitoring and laboratory testing; and 

19 (C) the impact on the direct and indirect 

20 costs of health care, which may include costs 

21 due to length of hospital stay, length of time to 

22 identify safe and effective dosing for patients, 

23 toxicity and adverse events, and other measures 

24 of health care utilization and outcomes; 


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1 (3) accelerates development and rapid adoption 

2 by providers and payers as appropriate, of com3 panion diagnostic testing that could significantly en4 hance the safety of a medication by identifying pa5 tients at risk for toxic events from use of such medi6 cation or by improving dosing regimens for such 

7 medication; and 

8 (4) prioritizes the development of such tests for 

9 diseases and health conditions that have a signifi10 cant public health impact because of prevalence, risk 

11 of complications from treatment, and other factors 

12 determined appropriate by the Director. 

13 (g) AUTHORIZATION OF APPROPRIATIONS.—There is 

14 authorized to be appropriated to carry out this section, 

15 $30,000,000 for fiscal year 2007, and such sums as may 

16 be necessary for each of fiscal years 2008 through 2012. 

17 SEC. 8. SENSE OF THE SENATE REGARDING GENETIC NON18 DISCRIMINATION AND PRIVACY. 

19 It is the sense of the Senate that— 

20 (1) in order for personalized medicine to ad21 vance and achieve success in both reducing the bur22 den of disease and reducing health care costs, strong 

23 privacy protections, including protections against ge24 netic discrimination, must be enacted and imple25 mented; 


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1 (2) without a Federal law banning genetic dis2 crimination, people may fear losing their health in3 surance and their employment, and subsequently— 

4 (A) avoid participating in research that 

5 collects genetic information; and 

6 (B) even decline clinical molecular testing 

7 that may provide lifesaving information; 

8 (3) fear of genetic discrimination will slow the 

9 pace of discovery in research and hinder the uptake 

10 of molecular testing in a clinical setting, both of 

11 which will undermine efforts to translate and apply 

12 personalized medicine technology; and 

13 (4) adequate privacy protections, including a 

14 Federal prohibition against genetic discrimination, 

15 are necessary prerequisites to advancing personal16 ized medicine. 

Æ 


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