II 

110TH CONGRESS 

2D SESSION S. 3187 

To establish a comprehensive interagency response to reduce lung cancer 

mortality in a timely manner. 

IN THE SENATE OF THE UNITED STATES 

JUNE 25, 2008 

Mr. HAGEL (for himself and Mrs. FEINSTEIN) introduced the following bill; 

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

A BILL 

To establish a comprehensive interagency response to reduce 

lung cancer mortality in a timely manner. 

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 ‘‘Lung Cancer Mortality 

5 Reduction Act of 2008’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 

8 (1) Lung cancer is the leading cause of cancer 

9 death for both men and women, accounting for 28 

10 percent of all cancer deaths. 


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1 (2) Lung cancer kills more people annually 

2 than breast cancer, prostate cancer, colon cancer, 

3 liver cancer, melanoma, and kidney cancer combined. 

4 (3) Since the National Cancer Act of 1971 

5 (Public Law 92–218; 85 Stat. 778), coordinated and 

6 comprehensive research has raised the 5-year sur7 vival rates for breast cancer to 88 percent, for pros8 tate cancer to 99 percent, and for colon cancer to 

9 64 percent. 

10 (4) However, the 5-year survival rate for lung 

11 cancer is still only 15 percent and a similar coordi12 nated and comprehensive research effort is required 

13 to achieve increases in lung cancer survivability 

14 rates. 

15 (5) Sixty percent of lung cancer cases are now 

16 diagnosed as nonsmokers or former smokers. 

17 (6) Two-thirds of nonsmokers diagnosed with 

18 lung cancer are women. 

19 (7) Certain minority populations, such as Afri20 can-American males, have disproportionately high 

21 rates of lung cancer incidence and mortality, not22 withstanding their similar smoking rate. 

23 (8) Members of the baby boomer generation are 

24 entering their sixties, the most common age at which 

25 people develop lung cancer. 


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1 (9) Tobacco addiction and exposure to other 

2 lung cancer carcinogens such as Agent Orange and 

3 other herbicides and battlefield emissions are serious 

4 problems among military personnel and war vet5 erans. 

6 (10) Significant and rapid improvements in 

7 lung cancer mortality can be expected through great8 er use and access to lung cancer screening tests for 

9 at-risk individuals. 

10 (11) Additional strategies are necessary to fur11 ther enhance the existing tests and therapies avail12 able to diagnose and treat lung cancer in the future. 

13 (12) The August 2001 Report of the Lung 

14 Cancer Progress Review Group of the National Can15 cer Institute stated that funding for lung cancer re16 search was ‘‘far below the levels characterized for 

17 other common malignancies and far out of propor18 tion to its massive health impact’’. 

19 (13) The Report of the Lung Cancer Progress 

20 Review Group identified as its ‘‘highest priority’’ the 

21 creation of integrated, multidisciplinary, multi-insti22 tutional research consortia organized around the 

23 problem of lung cancer rather than around specific 

24 research disciplines. 


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1 (14) The United States must enhance its re2 sponse to the issues raised in the Report of the 

3 Lung Cancer Progress Review Group, and this can 

4 be accomplished through the establishment of a co5 ordinated effort designed to reduce the lung cancer 

6 mortality rate by 50 percent by 2015 and targeted 

7 funding to support this coordinated effort. 

8 SEC. 3. SENSE OF THE SENATE CONCERNING INVESTMENT 

9 IN LUNG CANCER RESEARCH. 

10 It is the sense of the Senate that— 

11 (1) lung cancer mortality reduction should be 

12 made a national public health priority; and 

13 (2) a comprehensive mortality reduction pro14 gram coordinated by the Secretary of Health and 

15 Human Service is justified and necessary to ade16 quately address and reduce lung cancer mortality. 

17 SEC. 4. LUNG CANCER MORTALITY REDUCTION PROGRAM. 

18 (a) IN GENERAL.—Subpart 1 of part C of title IV 

19 of the Public Health Service Act (42 U.S.C. 285 et seq.) 

20 is amended by adding at the end the following: 

21 ‘‘SEC. 417E. LUNG CANCER MORTALITY REDUCTION PRO22 GRAM. 

23 ‘‘(a) IN GENERAL.—Not later than 6 months after 

24 the date of enactment of the Lung Cancer Mortality Re25 duction Act of 2008, the Secretary, in consultation with 


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1 the Secretary of Defense, the Secretary of Veterans Af2 fairs, the Director of the National Institutes of Health, 

3 the Director of the Centers for Disease Control and Pre4 vention, the Administrator of the Food and Drug Adminis5 tration, the Director of the Centers for Medicare & Med6 icaid Services, the Director of the National Center on Mi7 nority Health and Health Disparities, and other members 

8 of the Lung Cancer Advisory Board established under sec9 tion 6 of the Lung Cancer Mortality Reduction Act of 

10 2008, shall implement a comprehensive program to 

11 achieve a 50 percent reduction in the mortality rate of 

12 lung cancer by 2015. 

13 ‘‘(b) REQUIREMENTS.—The program implemented 

14 under subsection (a) shall include at least the following: 

15 ‘‘(1) With respect to the National Institutes of 

16 Health— 

17 ‘‘(A) a strategic review and prioritization 

18 by the National Cancer Institute of research 

19 grants to achieve the goal of the program in re20 ducing lung cancer mortality; 

21 ‘‘(B) the provision of funds to enable the 

22 Airway Biology and Disease Branch of the Na23 tional Heart, Lung and Blood Institute to ex24 pand its research programs to include pre25 dispositions to lung cancer, the interrelationship 


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1 between lung cancer and other pulmonary and 

2 cardiac disease, and the diagnosis and treat3 ment of these interrelationships; 

4 ‘‘(C) the provision of funds to enable the 

5 National Institute of Biomedical Imaging and 

6 Bioengineering to expand its Quantum Grant 

7 Program and Image-Guided Interventions pro8 grams to expedite the development of computer 

9 assisted diagnostic, surgical, treatment and 

10 drug testing innovations to reduce lung cancer 

11 mortality; and 

12 ‘‘(D) the provision of funds to enable the 

13 National Institute for Environmental Health 

14 Sciences to implement research programs rel15 ative to lung cancer incidence. 

16 ‘‘(2) With respect to the Food and Drug Ad17 ministration— 

18 ‘‘(A) the establishment of a lung cancer 

19 mortality reduction drug program under sub20 title G of chapter V of the Federal Food, Drug, 

21 and Cosmetic Act; and 

22 ‘‘(B) compassionate access activities under 

23 section 561 of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 360bbb). 


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1 ‘‘(3) With respect to the Centers for Disease 

2 Control and Prevention, the establishment of a lung 

3 cancer mortality reduction program under section 

4 1511. 

5 ‘‘(4) With respect to the Agency for Healthcare 

6 Research and Quality, the conduct of a biannual re7 view of lung cancer screening, diagnostic and treat8 ment protocols, and the issuance of updated guide9 lines. 

10 ‘‘(5) The cooperation and coordination of all 

11 minority and health disparity programs within the 

12 Department of Health and Human Services to en13 sure that all aspects of the Lung Cancer Mortality 

14 Reduction Program adequately address the burden 

15 of lung cancer on minority and rural populations. 

16 ‘‘(6) The cooperation and coordination of all to17 bacco control and cessation programs within agen18 cies of the Department of Health and Human Serv19 ices to achieve the goals of the Lung Cancer Mor20 tality Reduction Program with particular emphasis 

21 on the coordination of drug and other cessation 

22 treatments with early detection protocols. 

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

24 is authorized to be appropriated to carry out this section— 


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1 ‘‘(1) $25,000,000 for fiscal year 2009 for the 

2 activities described in subsection (b)(1)(B), and such 

3 sums as may be necessary for each of fiscal years 

4 2010 through 2013; 

5 ‘‘(2) $25,000,000 for fiscal year 2009 for the 

6 activities described in subsection (b)(1)(C), and such 

7 sums as may be necessary for each of fiscal years 

8 2010 through 2013; 

9 ‘‘(3) $10,000,000 for fiscal year 2009 for the 

10 activities described in subsection (b)(1)(D), and such 

11 sums as may be necessary for each of fiscal years 

12 2010 through 2013; and 

13 ‘‘(4) $15,000,000 for fiscal year 2009 for the 

14 activities described in subsection (b)(3), and such 

15 sums as may be necessary for each of fiscal years 

16 2010 through 2013.’’. 

17 (b) FOOD, DRUG, AND COSMETIC ACT.—Chapter V 

18 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 351 et seq.) is amended by adding at the end the fol20 lowing: 


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1 ‘‘Subchapter G—Lung Cancer Mortality 

2 Reduction Programs 

3 ‘‘SEC. 581. LUNG CANCER MORTALITY REDUCTION PRO4 GRAM. 

5 ‘‘(a) IN GENERAL.—The Secretary shall implement 

6 a program to provide incentives of the type provided for 

7 in subchapter B of this chapter for the development of 

8 chemoprevention drugs for precancerous conditions of the 

9 lung, drugs for targeted therapeutic treatments and vac10 cines for lung cancer, and new agents to curtail or prevent 

11 nicotine addiction. The Secretary shall model the program 

12 implemented under this section on the program provided 

13 for under subchapter B of this chapter with respect cer14 tain drugs. 

15 ‘‘(b) APPLICATION OF PROVISIONS.—The Secretary 

16 shall apply the provisions of subchapter B of this chapter 

17 to drugs, biological products, and devices for the preven18 tion or treatment of lung cancer, including drugs, biologi19 cal products, and devices for chemoprevention of 

20 precancerous conditions of the lungs, vaccination against 

21 the development of lung cancer and therapeutic treatment 

22 for lung cancer. 

23 ‘‘(c) BOARD.—The Board established under section 

24 6 of the Lung Cancer Mortality Reduction Act of 2008 


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1 shall monitor the program implemented under this sec2 tion.’’. 

3 (c) ACCESS TO UNAPPROVED THERAPIES.—Section 

4 561(e) of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 360bbb(e)) is amended by inserting before the pe6 riod the following: ‘‘and shall include providing compas7 sionate access to drugs, biological products, and devices 

8 under the program under section 581, with substantial 

9 consideration being given to whether the totality of infor10 mation available to the Secretary regarding the safety and 

11 effectiveness of an investigational drug, as compared to 

12 the risk of morbidity and death from the disease, indicates 

13 that a patient may obtain more benefit than risk if treated 

14 with the drug, biological product, or device.’’. 

15 (d) CDC.—Title XV of the Public Health Service Act 

16 (42 U.S.C. 300k et seq.) is amended by adding at the end 

17 the following: 

18 ‘‘SEC. 1511. LUNG CANCER MORTALITY REDUCTION PRO19 GRAM. 

20 ‘‘(a) IN GENERAL.—The Secretary shall establish 

21 and implement an early disease research and management 

22 program targeted at the high incidence and mortality rates 

23 among minority and low-income populations. 


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1 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

2 is authorized to be appropriated, such sums as may be 

3 necessary to carry out this section.’’. 

4 SEC. 5. DEPARTMENT OF DEFENSE AND THE DEPARTMENT 

5 OF VETERANS AFFAIRS. 

6 The Secretary of Defense and the Secretary of Vet7 erans Affairs shall coordinate with the Secretary of Health 

8 and Human Services— 

9 (1) in the development of the Lung Cancer 

10 Mortality Reduction Program under section 417E; 

11 (2) in the implementation within the Depart12 ment of Defense and the Department of Veterans 

13 Affairs of an early detection and disease manage14 ment research program for military personnel and 

15 veterans whose smoking history and exposure to car16 cinogens during active duty service has increased 

17 their risk for lung cancer; and 

18 (3) in the implementation of coordinated care 

19 programs for military personnel and veterans diag20 nosed with lung cancer. 

21 SEC. 6. LUNG CANCER ADVISORY BOARD. 

22 (a) IN GENERAL.—The Secretary of Health and 

23 Human Services shall establish a Lung Cancer Advisory 

24 Board (referred to in this section as the ‘‘Board’’) to mon25 itor the programs established under this Act (and the 


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1 amendments made by this Act), provide annual reports to 

2 Congress concerning benchmarks, expenditures, lung can3 cer statistics, and the public health impact of such pro4 grams. 

5 (b) COMPOSITION.—The Board shall be composed 

6 of— 

7 (1) the Secretary of Health and Human Serv8 ices; 

9 (2) the Secretary of Defense; 

10 (3) the Secretary of Veterans Affairs; and 

11 (4) two representatives each from the fields of 

12 clinical medicine focused on lung cancer, lung cancer 

13 research, imaging, drug development, and lung can14 cer advocacy, to be appointed by the Secretary of 

15 Health and Human Services. 

16 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

17 For the purpose of carrying out the programs under 

18 this Act (and the amendments made by this Act), there 

19 is authorized to be appropriated such sums as may be nec20 essary for each of fiscal years 2009 through 2013. 

Æ 


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