II 

110TH CONGRESS 

1ST SESSION S. 976 

To secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the 

accuracy of disease diagnosis, increase the safety of drugs, and identify 

novel treatments. 

IN THE SENATE OF THE UNITED STATES 

MARCH 23, 2007 

Mr. OBAMA (for himself and Mr. BURR) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research 

and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel 

treatments. 

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 2007’’. 

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 diseases and drug responses, 

4 which has contributed to the advent of ‘‘personalized 

5 medicine’’. 

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 person’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 health care costs, and is fundamental to 

22 the practice of genome-based personalized medicine. 

23 (6) Pharmacogenomics is the study of how ge24 netic variation affects a person’s response to drugs. 

25 This relatively new field combines pharmacology (the 


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

2 and their functions) to develop safer and more effec3 tive medications and dosing regimens that will be 

4 tailored to an individual’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 extra 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 300 individuals inherit an inactive version of the 

15 gene encoding the metabolizing enzyme thiopurine 

16 methyltransferase (TPMT) from both their mother 

17 and father and, as a result, should receive only a 

18 fraction of the standard dose of purine drugs. In ad19 dition, 1 in 10 individuals have only 1 copy of the 

20 gene with variable function, and the dosage of 6-MP 

21 must be adjusted for a subset of these patients. Phy22 sicians now are able to screen for TPMT gene 

23 variants before administering these drugs. 

24 (11) Research into the genetics of breast cancer 

25 identified two pivotal genes, BRCA1 and BRCA2, 


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1 mutations in which correspond to a significantly in2 creased lifetime risk of developing breast and ovar3 ian cancer. Individuals in affected families or with 

4 specific risk factors may use genetic testing to iden5 tify whether they carry mutations in these genes and 

6 to inform their decisions about treatment options, 

7 including prophylatic mastectomy and oophorectomy. 

8 (12) Realizing the promise of personalized med9 icine will require continued Federal leadership and 

10 agency collaboration, expansion and acceleration of 

11 genomics research, a capable genomics workforce, in12 centives to encourage development and collection of 

13 data on the analytic and clinical validity and clinical 

14 utility of genomic tests and therapies, and improved 

15 regulation over the quality of genetic tests, direct-to16 consumer advertising of genetic tests, and use of 

17 personal genomic information. 

18 SEC. 3. DEFINITIONS. 

19 In this Act: 

20 (1) BIOBANK.—The term ‘‘biobank’’ means a 

21 shared repository of human biological specimens that 

22 may also include data associated with such speci23 mens collected for medical or research purposes. 

24 Human biological specimens may include body 

25 fluids, tissues, blood, cells, or materials derived from 


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1 these sources, and data associated with such speci2 mens may include health information or environ3 mental data. 

4 (2) BIOMARKER.—The term ‘‘biomarker’’ 

5 means an analyte found in or derived from a patient 

6 specimen that is objectively measured and evaluated 

7 as an indicator of normal biologic processes, patho8 genic processes, or pharmacologic responses to a 

9 therapeutic intervention. 

10 (3) CLIA.—The term ‘‘CLIA’’ means the Clin11 ical Laboratory Improvement Amendments of 1988 

12 (42 U.S.C. 263a). 

13 (4) ENVIRONMENT.—The term ‘‘environment’’ 

14 means conditions or circumstances that are non15 genetic but may have a health impact. 

16 (5) GENETIC TEST.—The term ‘‘genetic test’’ 

17 means an analysis of human DNA, RNA, chro18 mosomes, proteins, or metabolites, that detects 

19 genotypes, mutations, or chromosomal and bio20 chemical changes. 

21 (6) LABORATORY-DEVELOPED GENETIC

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

23 test’’ means a genetic test that is designed, vali24 dated, conducted, and offered as a service by a clin25 ical laboratory subject to CLIA using either comVerDate Aug 31 2005 00:26 Mar 28, 2007 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S976.IS S976

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1 mercially available analyte specific reagents (FDA2 regulated) or reagents prepared by the laboratory 

3 (not FDA-regulated), or some combination thereof. 

4 (7) PHARMACOGENETIC TEST.—The term 

5 ‘‘pharmacogenetic test’’ means a genetic test in6 tended to identify individual variations in DNA se7 quence related to drug absorption and disposition 

8 (pharmacokinetics) or drug action 

9 (pharmacodynamics), including polymorphic vari10 ation in the genes that encode the functions of 

11 transporters, receptors, metabolizing enzymes, and 

12 other proteins. 

13 (8) PHARMACOGENOMIC TEST.— 

14 (A) IN GENERAL.—The term 

15 ‘‘pharmacogenomic test’’ means a genetic test 

16 intended to identify individual variations in sin17 gle-nucleotide polymorphisms, haplotype mark18 ers, or alterations in gene expression or inac19 tivation, that may be correlated with pharma20 cological function and therapeutic response. 

21 (B) VARIATIONS AND ALTERATIONS.—For 

22 purposes of this paragraph, the variations or al23 terations referred to in subparagraph (A) may 

24 be a pattern or profile of change, rather than 

25 a change in an individual marker. 


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1 (9) SECRETARY.—The term ‘‘Secretary’’ means 

2 the Secretary of Health and Human Services. 

3 SEC. 4. GENOMICS AND PERSONALIZED MEDICINE INTER4 AGENCY WORKING GROUP. 

5 (a) IN GENERAL.—Not later than 90 days after the 

6 date of enactment of this Act, the Secretary shall establish 

7 within the Department of Health and Human Services the 

8 Genomics and Personalized Medicine Interagency Working 

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

10 (b) DUTIES.—The IWG shall facilitate collaboration, 

11 coordination, and integration of activities within the De12 partment of Health and Human Services and other Fed13 eral agencies, and among such agencies and relevant pub14 lic and private entities, by— 

15 (1) reviewing current and proposed genomic ini16 tiatives, in order to identify shared interests and le17 verage resources; 

18 (2) prioritizing new genomic initiatives, based 

19 on areas of need as measured by public health im20 pact; 

21 (3) reaching consensus on standardized genomic 

22 terminology, definitions, and data code sets for 

23 adoption and use in Federally conducted or sup24 ported programs; 


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1 (4) establishing and disseminating quality 

2 standards and guidelines for the collection, proc3 essing, archiving, storage, and dissemination of 

4 genomic samples and data for research and clinical 

5 purposes; 

6 (5) developing and promulgating guidelines re7 garding procedures, protocols, and policies for the 

8 safeguarding of the privacy of biobank subjects, in 

9 accordance with the Office for Human Research 

10 Protection and Clinical Research Policy Analysis and 

11 Coordination Program at the National Institutes of 

12 Health, and other guidelines as appropriate; 

13 (6) reviewing and making recommendations to 

14 address ownership and patient access issues with re15 spect to genomic samples and analyses; 

16 (7) developing and promulgating guidelines re17 garding procedures, protocols, and policies for access 

18 to patient data, genomic samples, and associated 

19 health information by non-governmental entities for 

20 research purposes; 

21 (8) developing and disseminating guidelines for 

22 constructing informed consent forms that ensure pa23 tient privacy and confidentiality of associated clinical 

24 data and information, understanding of research 


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1 procedures, benefits, risks, rights, and responsibil2 ities, and continuous voluntary participation; and 

3 (9) providing recommendations for the estab4 lishment of a distributed database, pursuant to sec5 tion 5. 

6 (c) IWG CHAIRPERSON.—The Secretary, or his or 

7 her designee, shall serve as chairperson of the IWG. 

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

9 IWG shall include members from the— 

10 (1) National Institutes of Health; 

11 (2) Centers for Disease Control and Prevention; 

12 (3) Food and Drug Administration; 

13 (4) Health Resources and Services Administra14 tion; 

15 (5) Office of Minority Health; 

16 (6) Agency for Healthcare Research and Qual17 ity; 

18 (7) Centers for Medicare & Medicaid Services; 

19 (8) Veterans Health Administration; 

20 (9) Office of the National Coordinator for 

21 Health Information Technology; 

22 (10) Department of Energy; 

23 (11) Armed Forces Institute of Pathology; 

24 (12) Indian Health Service; and 


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1 (13) other Federal departments and agencies as 

2 determined appropriate by the Secretary. 

3 (e) PUBLIC INPUT.—The IWG shall solicit input 

4 from relevant stakeholders with respect to meeting the du5 ties described in subsection (b). 

6 (f) REPORT.—Not later than 18 months after the 

7 date of enactment of this Act, the Secretary shall prepare 

8 and submit a report to the appropriate committees of Con9 gress and to the public on IWG deliberations, activities, 

10 and recommendations with respect to meeting the duties 

11 described in subsection (b). 

12 (g) TERMINATION.—The IWG shall terminate after 

13 submitting the report described in subsection (f), or later 

14 at the discretion of the Secretary. 

15 (h) AUTHORIZATION OF APPROPRIATIONS.—There 

16 are authorized to be appropriated to carry out this section, 

17 $1,000,000 for fiscal years 2008 and 2009. 

18 SEC. 5. NATIONAL BIOBANKING INITIATIVE. 

19 (a) IN GENERAL.—The Secretary shall advance the 

20 field of genomics and personalized medicine through estab21 lishment of a national biobanking distributed database for 

22 the collection and integration of genomic data, and associ23 ated environmental and clinical health information, which 

24 shall facilitate synthesis and pooled analysis of such data. 


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1 (b) DATABASE.—With respect to the national bio2 banking distributed database, the Secretary shall— 

3 (1) adhere to relevant guidelines, policies, and 

4 recommendations of the IWG, pursuant to section 4; 

5 (2) establish, directly or by contract, a single 

6 point of authority to manage operations of the data7 base; 

8 (3) incorporate biobanking data from Federally 

9 conducted or supported genomics initiatives, as fea10 sible; 

11 (4) encourage voluntary submission of bio12 banking data obtained or analyzed with private or 

13 non-Federal funds; 

14 (5) facilitate submission of data, including se15 cure and efficient electronic submission; 

16 (6) allow public use of data only— 

17 (A) with appropriate privacy safeguards in 

18 place; and 

19 (B) for health research purposes; 

20 (7) determine appropriate procedures for access 

21 by nongovernmental entities to biobank data for re22 search and development of new or improved tests 

23 and treatments, and submission of data generated 

24 from such samples to the Food and Drug AdminisVerDate Aug 31 2005 00:26 Mar 28, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S976.IS S976

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1 tration as part of the approval process for drugs and 

2 devices; 

3 (8) conduct, directly or by contract, analytical 

4 research, including clinical, epidemiological, and so5 cial research, using biobank data; and 

6 (9) make analytic findings from biobanking ini7 tiatives supported by Federal funding publicly avail8 able within an appropriate timeframe to be deter9 mined by the Secretary. 

10 (c) RULE OF CONSTRUCTION.—Nothing in this sec11 tion shall be construed to require the submission or ac12 ceptance of biological specimens. 

13 (d) BIOBANK INITIATIVES GRANTS.— 

14 (1) IN GENERAL.—The Secretary shall establish 

15 a grant program for eligible entities to develop or ex16 pand biobanking initiatives to increase under17 standing of how genomics interacts with environ18 mental factors to cause disease, and to accelerate 

19 the development of genomic-based tests and treat20 ments. 

21 (2) ELIGIBLE ENTITIES.— 

22 (A) IN GENERAL.—For purposes of this 

23 subsection, eligible entities include academic 

24 medical centers and other entities determined 

25 appropriate by the Secretary. Eligible entities 


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1 desiring a grant under this subsection shall 

2 submit an application to the Secretary in ac3 cordance with this subsection, at such time, in 

4 such manner, and containing such additional 

5 information as the Secretary may require. 

6 (B) PRIORITY.—Academic medical centers 

7 that partner with health care professionals 

8 within their communities in order to obtain di9 verse genomic samples shall be given priority 

10 for awards made under this subsection. 

11 (3) REQUIREMENTS.—The Secretary shall en12 sure that biobanks supported by grant awards under 

13 this section— 

14 (A) adhere to guidelines and recommenda15 tions developed pursuant to section 4; 

16 (B) are established to complement activi17 ties related to the implementation of current 

18 Federal biobanking research initiatives, as fea19 sible; 

20 (C) are based on well-defined populations, 

21 including population-based registries of disease 

22 and family-based registries; 

23 (D) collect data from participants with di24 verse genomic profiles, demographics, environVerDate Aug 31 2005 00:26 Mar 28, 2007 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S976.IS S976

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1 mental exposures, and presence or absence of 

2 health conditions and diseases, as appropriate; 

3 (E) meet quality standards for the collec4 tion, processing, archiving, storage, and dis5 semination of data, which shall be developed by 

6 the IWG; 

7 (F) have practical experience and dem8 onstrated expertise in genomics and its clinical 

9 and public health applications; 

10 (G) establish mechanisms to ensure patient 

11 privacy and protection of information from non12 health applications and, as feasible, patient ac13 cess to genomic samples for clinical testing pur14 poses; and 

15 (H) contribute genomic and associated 

16 clinical and environmental data and analyses to 

17 the national biobanking distributed database, 

18 pursuant to subsection (b). 

19 (4) USE OF FUNDS.—An eligible entity that re20 ceives a grant under this subsection shall use the 

21 grant funds to develop or expand a biobanking ini22 tiative, which may include the following activities: 

23 (A) Support for scientific and community 

24 advisory committees. 


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1 (B) Recruitment and education of partici2 pants. 

3 (C) Development of consent protocols. 

4 (D) Obtaining genetic samples and associ5 ated environmental and clinical information. 

6 (E) Establishment and maintenance of se7 cure storage for genetic samples and clinical in8 formation. 

9 (F) Conduct of data analyses and evidence10 based systemic reviews that allow for the fol11 lowing: 

12 (i) Identification of biomarkers and 

13 other surrogate markers to improve pre14 dictions of onset of disease, response to 

15 therapy, and clinical outcomes. 

16 (ii) Increased understanding of gene17 environment interactions. 

18 (iii) Development of genetic screening, 

19 diagnostic, and therapeutic interventions. 

20 (iv) Genotypic characterization of tis21 sue samples. 

22 (G) Other activities, as determined appro23 priate by the Secretary. 

24 (5) QUALITY ASSURANCE.—The Secretary may 

25 enter into a contract with an external entity to 


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1 evaluate grantees under this subsection to ensure 

2 that quality standards are met. 

3 (e) APPLICATION OF PRIVACY RULES.—Nothing in 

4 this Act shall be construed to supercede the requirements 

5 for the protection of patient privacy under— 

6 (1) the Federal regulations promulgated under 

7 section 264(c) of the Health Insurance Portability 

8 and Accountability Act of 1996 (42 U.S.C. 1320d– 

9 2 note); or 

10 (2) sections 552 and 552a of title 5, United 

11 States Code (5 U.S.C. App.). 

12 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section, 

14 $75,000,000 for fiscal year 2009, and such sums as may 

15 be necessary for each of fiscal years 2010 through 2014. 

16 SEC. 6. GENOMICS WORKFORCE AND TRAINING. 

17 (a) GENETICS AND GENOMICS TRAINING.—The Sec18 retary, directly or through contracts or grants to eligible 

19 entities, which shall include professional genetics and 

20 genomics societies, academic institutions, and other enti21 ties as determined appropriate by the Secretary, shall im22 prove the adequacy of genetics and genomics training for 

23 diagnosis, treatment, and counseling of adults and chil24 dren for both rare and common disorders, through support 

25 of efforts to— 


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1 (1) develop and disseminate model training pro2 gram and residency curricula and teaching materials 

3 that reflect the new knowledge and evolving practice 

4 of genetics and genomics; 

5 (2) assist the review of board and other certi6 fying examinations by professional societies and ac7 creditation bodies to ensure adequate focus on the 

8 fundamental principles of genomics; and 

9 (3) identify and evaluate options for distance or 

10 on-line learning for degree or continuing education 

11 programs. 

12 (b) INTEGRATION.—The Secretary, in collaboration 

13 with medical professional societies and accreditation bod14 ies and associations of health professional schools, shall 

15 support initiatives to increase the integration of genetics 

16 and genomics into all aspects of clinical and public health 

17 practice by promoting genetics and genomics competency 

18 across all clinical, public health, and laboratory disciplines 

19 through the development and dissemination of health pro20 fessional guidelines which shall— 

21 (1) include focus on appropriate techniques for 

22 collection and storage of genomics samples, adminis23 tration and interpretation of genetic and genomic 

24 tests, and subsequent clinical and public health deci25 sionmaking; and 


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1 (2) specifically target health professionals with2 out formal training or experience in the field of 

3 genomics. 

4 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

5 are authorized to be appropriated to carry out this section 

6 $5,000,000 for fiscal year 2008 and such sums as may 

7 be necessary for each of fiscal years 2009 through 2013. 

8 SEC. 7. REALIZING THE POTENTIAL OF PERSONALIZED 

9 MEDICINE. 

10 (a) NATIONAL ACADEMY OF SCIENCES STUDY.—Not 

11 later than 180 days after the date of enactment of this 

12 Act, the Secretary shall enter into a contract with the Na13 tional Research Council of the National Academy of 

14 Sciences to study and recommend appropriate incentives 

15 to encourage— 

16 (1) codevelopment of companion diagnostic test17 ing by a drug sponsor; 

18 (2) development of companion diagnostic test19 ing for already-approved drugs by the drug sponsor; 

20 (3) companion diagnostic test development by 

21 device companies that are not affiliated with the 

22 drug sponsor; and 

23 (4) action on other issues determined appro24 priate by the Secretary. 

25 (b) GENETIC TEST QUALITY.— 


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

2 the availability of information on, and safety and ef3 ficacy of, genetic tests, including pharmacogenetic 

4 and pharmacogenomic tests. 

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

6 than 30 days after the date of enactment of this 

7 Act, the Secretary shall enter into a contract with 

8 the Institute of Medicine to conduct a study and 

9 prepare a report that includes recommendations to 

10 improve Federal oversight and regulation of genetic 

11 tests, with specific recommendations on the imple12 mentation of the decision matrix under paragraph 

13 (3). Such study shall take into consideration rel14 evant reports by the Secretary’s Advisory Committee 

15 on Genetic Testing and other groups and shall be 

16 completed not later than 1 year after the date on 

17 which the Secretary entered into such contract. 

18 (3) DECISION MATRIX.— 

19 (A) IN GENERAL.—Not later than 18 

20 months after the date of enactment of this Act, 

21 the Secretary, taking into consideration the rec22 ommendations of the Institute of Medicine re23 port under paragraph (2), shall implement a de24 cision matrix (referred to in this section as the 

25 ‘‘matrix’’) to improve the oversight and regulaVerDate Aug 31 2005 00:26 Mar 28, 2007 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S976.IS S976

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1 tion of genetic tests, including 

2 pharmacogenomic and pharmacogenetic tests by 

3 determining— 

4 (i) the classification of all genetic 

5 tests; 

6 (ii) which categories of tests, includ7 ing laboratory-developed tests, require re8 view and the level of review needed for 

9 such categories of tests; 

10 (iii) which agency shall have oversight 

11 over the review process of such categories 

12 of tests that are determined to require re13 view; and 

14 (iv) to the extent practicable, which 

15 requirements the agency shall apply to the 

16 types of tests identified in clause (ii). 

17 (B) LEVEL OF REVIEW.—In determining 

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

19 Secretary shall take into consideration— 

20 (i) performance characteristics of the 

21 test and its target disease or condition; 

22 (ii) intended use of the test; 

23 (iii) potential for improved medical 

24 conditions and patient harms; and 

25 (iv) social consequences of the test. 


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1 (C) COMPARATIVE ANALYSIS.—To inform 

2 implementation of the matrix, the Secretary 

3 shall undertake a comparative analysis of lab4 oratory review requirements under CLIA and 

5 those of the Food and Drug Administration 

6 to— 

7 (i) assess and reduce unnecessary dif8 ferences in such requirements; 

9 (ii) eliminate redundancies and de10 crease burden of review, as practicable; 

11 and 

12 (iii) specify which elements of the test 

13 constitute a device that may be regulated 

14 by the Food and Drug Administration and 

15 which elements comprise a service that 

16 may be regulated under CLIA. 

17 (D) REGULATIONS.—The Secretary shall 

18 promulgate regulations to implement the matrix 

19 not later than the date specified under subpara20 graph (A). 

21 (E) TRANSITION PERIOD.—The Secretary 

22 may not require a laboratory to submit a report 

23 under section 510(k) or an application under 

24 section 515 of the Federal Food, Drug and 

25 Cosmetic Act (21 U.S.C. 301 et seq.) until 180 


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1 days after the regulations promulgated under 

2 subparagraph (D) take effect. 

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

4 through the Commissioner of Food and Drugs and 

5 the Administrator of the Centers for Medicare & 

6 Medicaid Services, shall— 

7 (A) develop or expand adverse event re8 porting systems to encompass reports of ad9 verse events resulting from genetic testing; 

10 (B) respond appropriately to any adverse 

11 events resulting from such testing; and 

12 (C) facilitate the use of genetic and 

13 genomic approaches, as feasible, to assess risk 

14 for, and reduce incidence of, adverse drug reac15 tions. 

16 (5) AUTHORIZATION OF APPROPRIATIONS.— 

17 There are authorized to be appropriated to carry out 

18 this subsection, $6,000,000 for fiscal year 2008, and 

19 such sums as may be necessary for each of fiscal 

20 years 2009 through 2013. 

21 (c) FOOD AND DRUG ADMINISTRATION.— 

22 (1) IN GENERAL.— 

23 (A) SUMMARY INFORMATION.—If a genetic 

24 test that is determined to be within the jurisdic25 tion of the Food and Drug Administration but 


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1 that does not require review as determined 

2 under the matrix, the sponsor of such test shall 

3 provide the Secretary with summary informa4 tion on how such test was validated and its per5 formance characteristics. Such information shall 

6 be in a standardized format and with standard7 ized content as specified by the Food and Drug 

8 Administration, and shall be made easily acces9 sible to the public. 

10 (B) SOURCE OF INFORMATION.—The in11 formation described under subparagraph (A) 

12 may be obtained from the labeling submitted 

13 for CLIA complexity categorization. 

14 (2) ENCOURAGEMENT OF COMPANION DIAG15 NOSTIC TESTING.—The Secretary may encourage 

16 the sponsor of a drug or biological product— 

17 (A) to codevelop a companion diagnostic 

18 test, after filing an investigational new drug ap19 plication or a new drug application to address 

20 significant safety concerns of the drug or bio21 logical product; 

22 (B) to develop a companion diagnostic test 

23 if phase IV data demonstrate significant safety 

24 or effectiveness concerns with use of the drug 

25 or biological product; and 


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1 (C) to relabel the drug or biological prod2 uct to require validated companion diagnostic 

3 testing when evidence of improved outcomes has 

4 been established in practice or if data dem5 onstrate significant safety concerns with use of 

6 such drug or biological product. 

7 (3) PHARMACOGENOMIC DATA SUBMISSION.— 

8 The Secretary shall encourage and facilitate vol9 untary pharmacogenomic data submission from drug 

10 sponsors, which may include— 

11 (A) the development and dissemination of 

12 guidance on relevant policies, procedure and 

13 practice regarding such submission; 

14 (B) the provision of technical assistance; 

15 (C) the establishment of a mechanism to 

16 store, maintain and analyze such data, in col17 laboration with the National Institutes of 

18 Health and the Centers for Disease Control and 

19 Prevention; 

20 (D) determining when such data may be 

21 used to support an investigational new drug or 

22 a new drug application; 

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

24 genomic approaches to understand and reduce 

25 adverse drug reactions; and 


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1 (F) other activities determined appropriate 

2 by the Commissioner. 

3 (4) TERMINATION OF CERTAIN ADVERTISING

4 CAMPAIGNS.—The Food and Drug Administration 

5 shall collaborate with the Federal Trade Commission 

6 to identify and terminate, pursuant to section 5 of 

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

8 advertising campaigns that make false, misleading, 

9 deceptive, or unfair claims about the benefits or 

10 risks of genetic tests. 

11 (d) CENTERS FOR MEDICARE & MEDICAID SERV12 ICES.— 

13 (1) IN GENERAL.—If a genetic test that is de14 termined to be within the jurisdiction of the Centers 

15 for Medicare & Medicaid Services but that does not 

16 require review as determined under the matrix, the 

17 sponsor of such test shall provide the Administrator 

18 of the Centers for Medicare & Medicaid Services 

19 with summary information on how the test was vali20 dated and its performance characteristics. Such in21 formation shall be in a standardized format and with 

22 standardized content as specified by the Centers for 

23 Medicare & Medicaid Services, and shall be made 

24 easily accessible to the public. 


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

2 validity, and reliability of clinical genetic tests that 

3 do not require premarket approval by or notification 

4 to the Food and Drug Administration, and to im5 prove oversight of genetic test laboratories, the Di6 rector of the Division of Laboratory Services of the 

7 Survey and Certification Group of the Center for 

8 Medicaid and State Operations of the Centers for 

9 Medicare & Medicaid Services, in collaboration with 

10 the Clinical Laboratory Improvement Advisory Com11 mittee at the Centers for Disease Control and Pre12 vention, shall establish a specialty area for molecular 

13 and biochemical genetic tests, in order to— 

14 (A) develop criteria for establishing ana15 lytic and clinical validity for genetic tests that 

16 are determined to require review under the ma17 trix; 

18 (B) specify requirements for proficiency 

19 testing for laboratories; 

20 (C) provide guidance regarding the scope 

21 of duty for laboratory directors; 

22 (D) make information easily accessible to 

23 the public about— 

24 (i) laboratory certification; and 


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1 (ii) analytic and clinical validity for 

2 genetic tests that are determined to require 

3 high level review under the matrix; and 

4 (E) conduct other activities at the discre5 tion of the Administrator of the Centers for 

6 Medicare & Medicaid Services. 

7 (3) REIMBURSEMENT.— 

8 (A) CODING.—To foster adoption of ge9 netic screening tools, the Administrator of the 

10 Centers for Medicare & Medicaid Services 

11 shall— 

12 (i) assess and update current proce13 dure terminology codes to encourage the 

14 rapid review and coverage of novel tests 

15 through the creation of new HCPCS codes 

16 and adoption of new CPT codes and with17 out undue reliance on national coverage 

18 determinations; and 

19 (ii) determine and implement fair and 

20 reasonable coverage policies and reimburse21 ment rates for medically necessary genetic 

22 and genomic treatments and services, in23 cluding laboratory testing. 

24 (B) BUDGET NEUTRALITY.—Before en25 hancing payment for a year pursuant to this 


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1 paragraph, the Secretary shall, if necessary, 

2 provide for an adjustment to payments made 

3 under part B of title XVIII of the Social Secu4 rity Act (42 U.S.C. 1395j et seq.) in that year 

5 to ensure that such payments shall be equal to 

6 aggregate payments that would have been made 

7 under such part in that year if this paragraph 

8 had not been enacted. 

9 (e) CENTERS FOR DISEASE CONTROL AND PREVEN10 TION.— 

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

12 later than 2 years after the date of enactment of 

13 this Act, the Director of the Centers for Disease 

14 Control and Prevention, with respect to genetic tests 

15 for which consumers have direct access, shall— 

16 (A) conduct an analysis of the public 

17 health impact of direct-to-consumer marketing 

18 to the extent possible from available data 

19 sources; 

20 (B) analyze the validity of claims made in 

21 direct-to-consumer marketing to determine 

22 whether such claims are substantiated by com23 petent and reliable scientific evidence; and 

24 (C) make recommendations to the Sec25 retary regarding necessary interventions to proVerDate Aug 31 2005 00:26 Mar 28, 2007 Jkt 059200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S976.IS S976

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1 tect the public from potential harms of direct2 to-consumer marketing and access to genetic 

3 tests. 

4 (2) PUBLIC AWARENESS.—The Director shall 

5 expand efforts to educate and increase awareness of 

6 the general public about genomics and its applica7 tions to improve health, prevent disease and elimi8 nate health disparities. Such efforts shall include 

9 the— 

10 (A) ongoing collection of data on the 

11 awareness, knowledge and use of genetic tests 

12 through public health surveillance systems, and 

13 analysis of the impact of such tests on popu14 lation health; and 

15 (B) integration of the use of validated ge16 netic and genomic tests in public health pro17 grams as appropriate. 

18 (3) AUTHORIZATION OF APPROPRIATIONS.— 

19 There are authorized to be appropriated to carry out 

20 this subsection, $10,000,000 for fiscal year 2008, 

21 and such sums as may be necessary for each of fis22 cal years 2009 through 2013. 

23 (f) AGENCY FOR HEALTHCARE RESEARCH AND

24 QUALITY.—The Director of the Agency for Healthcare 

25 Research and Quality, after consultation with the IWG 


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1 and other public and private organizations based in the 

2 United States and abroad, as appropriate, shall support 

3 the assessment of the clinical utility and cost-effectiveness 

4 of companion diagnostic tests that guide prescribing deci5 sions, through research that— 

6 (1) develops standardized tools and methodolo7 gies to assess the clinical utility and cost-effective8 ness of such tests, as well as criteria for use; 

9 (2) establishes and validates drug dosing algo10 rithms for which such tests can improve outcomes, 

11 taking into consideration— 

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

13 and mortality; 

14 (B) improved clinical outcomes and quality 

15 of life, including decreased requirements for 

16 monitoring and laboratory testing; and 

17 (C) the impact on the direct and indirect 

18 costs of health care, which may include costs 

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

20 identify safe and effective dosing for patients, 

21 toxicity and adverse events, and other measures 

22 of health care utilization and outcomes; 

23 (3) supports and expedites the development of 

24 clinical decision tools for clinical use of genetic tests, 

25 as warranted; and 


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1 (4) prioritizes the development of such tests for 

2 diseases and health conditions that have a signifi3 cant public health impact because of prevalence, risk 

4 of complications from treatment, and other factors 

5 determined appropriate by the Director. 

6 (g) AUTHORIZATION OF APPROPRIATIONS.—There 

7 are authorized to be appropriated to carry out this section, 

8 $10,000,000 for fiscal year 2008, and such sums as may 

9 be necessary for each of fiscal years 2009 through 2013. 

Æ 


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