II 

111TH CONGRESS 

1ST SESSION S. 332 

To establish a comprehensive interagency response to reduce lung cancer 

mortality in a timely manner. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 27, 2009 

Mrs. FEINSTEIN (for herself and Mr. BROWNBACK) 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 2009’’. 

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 enactment of the National Cancer 

5 Act of 1971 (Public Law 92–218; 85 Stat. 778), co6 ordinated and comprehensive research has raised the 

7 5-year survival rates for breast cancer to 88 percent, 

8 for prostate cancer to 99 percent, and for colon can9 cer to 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. 

24 (14) The United States must enhance its re25 sponse to the issues raised in the Report of the 


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1 Lung Cancer Progress Review Group, and this can 

2 be accomplished through the establishment of a co3 ordinated effort designed to reduce the lung cancer 

4 mortality rate by 50 percent by 2016 and through 

5 targeted funding to support this coordinated effort. 

6 SEC. 3. SENSE OF THE SENATE CONCERNING INVESTMENT 

7 IN LUNG CANCER RESEARCH. 

8 It is the sense of the Senate that— 

9 (1) lung cancer mortality reduction should be 

10 made a national public health priority; and 

11 (2) a comprehensive mortality reduction pro12 gram coordinated by the Secretary of Health and 

13 Human Services is justified and necessary to ade14 quately address and reduce lung cancer mortality. 

15 SEC. 4. LUNG CANCER MORTALITY REDUCTION PROGRAM. 

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

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

18 is amended by adding at the end the following: 

19 ‘‘SEC. 417G. LUNG CANCER MORTALITY REDUCTION PRO20 GRAM. 

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

22 the date of enactment of the Lung Cancer Mortality Re23 duction Act of 2009, the Secretary, in consultation with 

24 the Secretary of Defense, the Secretary of Veterans Af25 fairs, the Director of the National Institutes of Health, 


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1 the Director of the Centers for Disease Control and Pre2 vention, the Commissioner of the Food and Drug Adminis3 tration, the Administrator of the Centers for Medicare & 

4 Medicaid Services, the Director of the National Center on 

5 Minority Health and Health Disparities, and other mem6 bers of the Lung Cancer Advisory Board established under 

7 section 6 of the Lung Cancer Mortality Reduction Act of 

8 2009, shall implement a comprehensive program to 

9 achieve a 50 percent reduction in the mortality rate of 

10 lung cancer by 2016. 

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

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

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

14 Health— 

15 ‘‘(A) a strategic review and prioritization 

16 by the National Cancer Institute of research 

17 grants to achieve the goal of the program in re18 ducing lung cancer mortality; 

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

20 Airway Biology and Disease Branch of the Na21 tional Heart, Lung, and Blood Institute to ex22 pand its research programs to include pre23 dispositions to lung cancer, the interrelationship 

24 between lung cancer and other pulmonary and 


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1 cardiac disease, and the diagnosis and treat2 ment of these interrelationships; 

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

4 National Institute of Biomedical Imaging and 

5 Bioengineering to expand its Quantum Grant 

6 Program and Image-Guided Interventions pro7 grams to expedite the development of computer 

8 assisted diagnostic, surgical, treatment, and 

9 drug testing innovations to reduce lung cancer 

10 mortality; and 

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

12 National Institute of Environmental Health 

13 Sciences to implement research programs rel14 ative to lung cancer incidence. 

15 ‘‘(2) With respect to the Food and Drug Ad16 ministration— 

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

18 mortality reduction drug program under sub19 chapter G of chapter V of the Federal Food, 

20 Drug, and Cosmetic Act; and 

21 ‘‘(B) compassionate access activities under 

22 section 561 of the Federal Food, Drug, and 

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

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

25 Control and Prevention, the establishment of a lung 


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1 cancer mortality reduction program under section 

2 1511. 

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

4 Research and Quality, the conduct of a biannual re5 view of lung cancer screening, diagnostic and treat6 ment protocols, and the issuance of updated guide7 lines. 

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

9 minority and health disparity programs within the 

10 Department of Health and Human Services to en11 sure that all aspects of the Lung Cancer Mortality 

12 Reduction Program adequately address the burden 

13 of lung cancer on minority and rural populations. 

14 ‘‘(6) The cooperation and coordination of all to15 bacco control and cessation programs within agen16 cies of the Department of Health and Human Serv17 ices to achieve the goals of the Lung Cancer Mor18 tality Reduction Program with particular emphasis 

19 on the coordination of drug and other cessation 

20 treatments with early detection protocols. 

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

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

23 ‘‘(1) $25,000,000 for fiscal year 2010 for the 

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


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1 sums as may be necessary for each of fiscal years 

2 2011 through 2014; 

3 ‘‘(2) $25,000,000 for fiscal year 2010 for the 

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

5 sums as may be necessary for each of fiscal years 

6 2011 through 2014; 

7 ‘‘(3) $10,000,000 for fiscal year 2010 for the 

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

9 sums as may be necessary for each of fiscal years 

10 2011 through 2014; and 

11 ‘‘(4) $15,000,000 for fiscal year 2010 for the 

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

13 sums as may be necessary for each of fiscal years 

14 2011 through 2014.’’. 

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

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

17 351 et seq.) is amended by adding at the end the fol18 lowing: 

19 ‘‘Subchapter G—Lung Cancer Mortality 

20 Reduction Programs 

21 ‘‘SEC. 581. LUNG CANCER MORTALITY REDUCTION PRO22 GRAM. 

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

24 a program to provide incentives of the type provided for 

25 in subchapter B of this chapter for the development of 


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1 chemoprevention drugs for precancerous conditions of the 

2 lung, drugs for targeted therapeutic treatments and vac3 cines for lung cancer, and new agents to curtail or prevent 

4 nicotine addiction. The Secretary shall model the program 

5 implemented under this section on the program provided 

6 for under subchapter B of this chapter with respect to cer7 tain drugs. 

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

9 shall apply the provisions of subchapter B of this chapter 

10 to drugs, biological products, and devices for the preven11 tion or treatment of lung cancer, including drugs, biologi12 cal products, and devices for chemoprevention of 

13 precancerous conditions of the lungs, vaccination against 

14 the development of lung cancer, and therapeutic treatment 

15 for lung cancer. 

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

17 6 of the Lung Cancer Mortality Reduction Act of 2009 

18 shall monitor the program implemented under this sec19 tion.’’. 

20 (c) ACCESS TO UNAPPROVED THERAPIES.—Section 

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

22 U.S.C. 360bbb(e)) is amended by inserting before the pe23 riod the following: ‘‘and shall include providing compas24 sionate access to drugs, biological products, and devices 

25 under the program under section 581, with substantial 


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1 consideration being given to whether the totality of infor2 mation available to the Secretary regarding the safety and 

3 effectiveness of an investigational drug, as compared to 

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

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

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

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

8 (42 U.S.C. 300k et seq.) is amended by adding at the end 

9 the following: 

10 ‘‘SEC. 1511. LUNG CANCER MORTALITY REDUCTION PRO11 GRAM. 

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

13 and implement an early disease research and management 

14 program targeted at the high incidence and mortality rates 

15 among minority and low-income populations. 

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

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

18 necessary to carry out this section.’’. 

19 SEC. 5. DEPARTMENT OF DEFENSE AND THE DEPARTMENT 

20 OF VETERANS AFFAIRS. 

21 The Secretary of Defense and the Secretary of Vet22 erans Affairs shall coordinate with the Secretary of Health 

23 and Human Services— 

24 (1) in the development of the Lung Cancer 

25 Mortality Reduction Program under section 417E of 


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1 part C of title IV of the Public Health Service Act, 

2 as amended by section 4; 

3 (2) in the implementation within the Depart4 ment of Defense and the Department of Veterans 

5 Affairs of an early detection and disease manage6 ment research program for military personnel and 

7 veterans whose smoking history and exposure to car8 cinogens during active duty service has increased 

9 their risk for lung cancer; and 

10 (3) in the implementation of coordinated care 

11 programs for military personnel and veterans diag12 nosed with lung cancer. 

13 SEC. 6. LUNG CANCER ADVISORY BOARD. 

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

15 Human Services shall establish a Lung Cancer Advisory 

16 Board (referred to in this section as the ‘‘Board’’) to mon17 itor the programs established under this Act (and the 

18 amendments made by this Act), and provide annual re19 ports to Congress concerning benchmarks, expenditures, 

20 lung cancer statistics, and the public health impact of such 

21 programs. 

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

23 of— 

24 (1) the Secretary of Health and Human Serv25 ices; 


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1 (2) the Secretary of Defense; 

2 (3) the Secretary of Veterans Affairs; and 

3 (4) two representatives each from the fields 

4 of— 

5 (A) clinical medicine focused on lung can6 cer; 

7 (B) lung cancer research; 

8 (C) imaging; 

9 (D) drug development; and 

10 (E) lung cancer advocacy, 

11 to be appointed by the Secretary of Health and 

12 Human Services. 

13 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

14 For the purpose of carrying out the programs under 

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

16 is authorized to be appropriated such sums as may be nec17 essary for each of fiscal years 2010 through 2014. 

Æ 


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