A bill to establish a comprehensive interagency response to reduce lung cancer mortality in a timely manner.

Summary: Lung Cancer Mortality Reduction Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (the Secretary) to implement a comprehensive program to achieve a 50% reduction in the mortality rate of lung cancer by 2015. Includes within such program: (1) a strategic review and prioritization of research grants; (2) an expansion of research programs, such as on predispositions to lung cancer; and (3) the expedited development of computer assisted diagnostic, surgical, treatment, and drug testing innovations.

Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to provide incentives for the development of chemoprevention drugs for precancerous conditions of the lung, drugs for targeted therapeutic treatments and vaccines for lung cancer, and new agents to curtail or prevent nicotine addiction.

Provides for compassionate access to drugs, biological products, and devices under the lung cancer mortality reduction program. Requires the Secretary to establish an early disease research and management program targeted at the high incidence and mortality rates among minority and low income populations.

Requires the Secretary of Defense and the Secretary of Veterans Affairs to coordinate with the Secretary in: (1) the development of the lung cancer mortality reduction program under this Act; (2) the implementation of an early detection and disease management research program for military personnel and veterans whose smoking history and exposure to carcinogens during active duty service has increased their risk for lung cancer; and (3) the implementation of coordinated care programs for military personnel and veterans diagnosed with lung cancer.

Requires the Secretary to establish a Lung Cancer Advisory Board to monitor the programs established under this Act.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Lung Cancer Mortality Reduction Act 
of 2008''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Lung cancer is the leading cause of cancer death for 
        both men and women, accounting for 28 percent of all cancer 
        deaths.
            (2) Lung cancer kills more people annually than breast 
        cancer, prostate cancer, colon cancer, liver cancer, melanoma, 
        and kidney cancer combined.
            (3) Since the National Cancer Act of 1971 (Public Law 92-
        218; 85 Stat. 778), coordinated and comprehensive research has 
        raised the 5-year survival rates for breast cancer to 88 
        percent, for prostate cancer to 99 percent, and for colon 
        cancer to 64 percent.
            (4) However, the 5-year survival rate for lung cancer is 
        still only 15 percent and a similar coordinated and 
        comprehensive research effort is required to achieve increases 
        in lung cancer survivability rates.
            (5) Sixty percent of lung cancer cases are now diagnosed as 
        nonsmokers or former smokers.
            (6) Two-thirds of nonsmokers diagnosed with lung cancer are 
        women.
            (7) Certain minority populations, such as African-American 
        males, have disproportionately high rates of lung cancer 
        incidence and mortality, notwithstanding their similar smoking 
        rate.
            (8) Members of the baby boomer generation are entering 
        their sixties, the most common age at which people develop lung 
        cancer.
            (9) Tobacco addiction and exposure to other lung cancer 
        carcinogens such as Agent Orange and other herbicides and 
        battlefield emissions are serious problems among military 
        personnel and war veterans.
            (10) Significant and rapid improvements in lung cancer 
        mortality can be expected through greater use and access to 
        lung cancer screening tests for at-risk individuals.
            (11) Additional strategies are necessary to further enhance 
        the existing tests and therapies available to diagnose and 
        treat lung cancer in the future.
            (12) The August 2001 Report of the Lung Cancer Progress 
        Review Group of the National Cancer Institute stated that 
        funding for lung cancer research was ``far below the levels 
        characterized for other common malignancies and far out of 
        proportion to its massive health impact''.
            (13) The Report of the Lung Cancer Progress Review Group 
        identified as its ``highest priority'' the creation of 
        integrated, multidisciplinary, multi-institutional research 
        consortia organized around the problem of lung cancer rather 
        than around specific research disciplines.
            (14) The United States must enhance its response to the 
        issues raised in the Report of the Lung Cancer Progress Review 
        Group, and this can be accomplished through the establishment 
        of a coordinated effort designed to reduce the lung cancer 
        mortality rate by 50 percent by 2015 and targeted funding to 
        support this coordinated effort.

SEC. 3. SENSE OF THE SENATE CONCERNING INVESTMENT IN LUNG CANCER 
              RESEARCH.

    It is the sense of the Senate that--
            (1) lung cancer mortality reduction should be made a 
        national public health priority; and
            (2) a comprehensive mortality reduction program coordinated 
        by the Secretary of Health and Human Service is justified and 
        necessary to adequately address and reduce lung cancer 
        mortality.

SEC. 4. LUNG CANCER MORTALITY REDUCTION PROGRAM.

    (a) In General.--Subpart 1 of part C of title IV of the Public 
Health Service Act (42 U.S.C. 285 et seq.) is amended by adding at the 
end the following:

``SEC. 417E. LUNG CANCER MORTALITY REDUCTION PROGRAM.

    ``(a) In General.--Not later than 6 months after the date of 
enactment of the Lung Cancer Mortality Reduction Act of 2008, the 
Secretary, in consultation with the Secretary of Defense, the Secretary 
of Veterans Affairs, the Director of the National Institutes of Health, 
the Director of the Centers for Disease Control and Prevention, the 
Administrator of the Food and Drug Administration, the Director of the 
Centers for Medicare & Medicaid Services, the Director of the National 
Center on Minority Health and Health Disparities, and other members of 
the Lung Cancer Advisory Board established under section 6 of the Lung 
Cancer Mortality Reduction Act of 2008, shall implement a comprehensive 
program to achieve a 50 percent reduction in the mortality rate of lung 
cancer by 2015.
    ``(b) Requirements.--The program implemented under subsection (a) 
shall include at least the following:
            ``(1) With respect to the National Institutes of Health--
                    ``(A) a strategic review and prioritization by the 
                National Cancer Institute of research grants to achieve 
                the goal of the program in reducing lung cancer 
                mortality;
                    ``(B) the provision of funds to enable the Airway 
                Biology and Disease Branch of the National Heart, Lung 
                and Blood Institute to expand its research programs to 
                include predispositions to lung cancer, the 
                interrelationship between lung cancer and other 
                pulmonary and cardiac disease, and the diagnosis and 
                treatment of these interrelationships;
                    ``(C) the provision of funds to enable the National 
                Institute of Biomedical Imaging and Bioengineering to 
                expand its Quantum Grant Program and Image-Guided 
                Interventions programs to expedite the development of 
                computer assisted diagnostic, surgical, treatment and 
                drug testing innovations to reduce lung cancer 
                mortality; and
                    ``(D) the provision of funds to enable the National 
                Institute for Environmental Health Sciences to 
                implement research programs relative to lung cancer 
                incidence.
            ``(2) With respect to the Food and Drug Administration--
                    ``(A) the establishment of a lung cancer mortality 
                reduction drug program under subtitle G of chapter V of 
                the Federal Food, Drug, and Cosmetic Act; and
                    ``(B) compassionate access activities under section 
                561 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360bbb).
            ``(3) With respect to the Centers for Disease Control and 
        Prevention, the establishment of a lung cancer mortality 
        reduction program under section 1511.
            ``(4) With respect to the Agency for Healthcare Research 
        and Quality, the conduct of a biannual review of lung cancer 
        screening, diagnostic and treatment protocols, and the issuance 
        of updated guidelines.
            ``(5) The cooperation and coordination of all minority and 
        health disparity programs within the Department of Health and 
        Human Services to ensure that all aspects of the Lung Cancer 
        Mortality Reduction Program adequately address the burden of 
        lung cancer on minority and rural populations.
            ``(6) The cooperation and coordination of all tobacco 
        control and cessation programs within agencies of the 
        Department of Health and Human Services to achieve the goals of 
        the Lung Cancer Mortality Reduction Program with particular 
        emphasis on the coordination of drug and other cessation 
        treatments with early detection protocols.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section--
            ``(1) $25,000,000 for fiscal year 2009 for the activities 
        described in subsection (b)(1)(B), and such sums as may be 
        necessary for each of fiscal years 2010 through 2013;
            ``(2) $25,000,000 for fiscal year 2009 for the activities 
        described in subsection (b)(1)(C), and such sums as may be 
        necessary for each of fiscal years 2010 through 2013;
            ``(3) $10,000,000 for fiscal year 2009 for the activities 
        described in subsection (b)(1)(D), and such sums as may be 
        necessary for each of fiscal years 2010 through 2013; and
            ``(4) $15,000,000 for fiscal year 2009 for the activities 
        described in subsection (b)(3), and such sums as may be 
        necessary for each of fiscal years 2010 through 2013.''.
    (b) Food, Drug, and Cosmetic Act.--Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:

        ``Subchapter G--Lung Cancer Mortality Reduction Programs

``SEC. 581. LUNG CANCER MORTALITY REDUCTION PROGRAM.

    ``(a) In General.--The Secretary shall implement a program to 
provide incentives of the type provided for in subchapter B of this 
chapter for the development of chemoprevention drugs for precancerous 
conditions of the lung, drugs for targeted therapeutic treatments and 
vaccines for lung cancer, and new agents to curtail or prevent nicotine 
addiction. The Secretary shall model the program implemented under this 
section on the program provided for under subchapter B of this chapter 
with respect certain drugs.
    ``(b) Application of Provisions.--The Secretary shall apply the 
provisions of subchapter B of this chapter to drugs, biological 
products, and devices for the prevention or treatment of lung cancer, 
including drugs, biological products, and devices for chemoprevention 
of precancerous conditions of the lungs, vaccination against the 
development of lung cancer and therapeutic treatment for lung cancer.
    ``(c) Board.--The Board established under section 6 of the Lung 
Cancer Mortality Reduction Act of 2008 shall monitor the program 
implemented under this section.''.
    (c) Access to Unapproved Therapies.--Section 561(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(e)) is amended by 
inserting before the period the following: ``and shall include 
providing compassionate access to drugs, biological products, and 
devices under the program under section 581, with substantial 
consideration being given to whether the totality of information 
available to the Secretary regarding the safety and effectiveness of an 
investigational drug, as compared to the risk of morbidity and death 
from the disease, indicates that a patient may obtain more benefit than 
risk if treated with the drug, biological product, or device.''.
    (d) CDC.--Title XV of the Public Health Service Act (42 U.S.C. 300k 
et seq.) is amended by adding at the end the following:

``SEC. 1511. LUNG CANCER MORTALITY REDUCTION PROGRAM.

    ``(a) In General.--The Secretary shall establish and implement an 
early disease research and management program targeted at the high 
incidence and mortality rates among minority and low-income 
populations.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

SEC. 5. DEPARTMENT OF DEFENSE AND THE DEPARTMENT OF VETERANS AFFAIRS.

    The Secretary of Defense and the Secretary of Veterans Affairs 
shall coordinate with the Secretary of Health and Human Services--
            (1) in the development of the Lung Cancer Mortality 
        Reduction Program under section 417E;
            (2) in the implementation within the Department of Defense 
        and the Department of Veterans Affairs of an early detection 
        and disease management research program for military personnel 
        and veterans whose smoking history and exposure to carcinogens 
        during active duty service has increased their risk for lung 
        cancer; and
            (3) in the implementation of coordinated care programs for 
        military personnel and veterans diagnosed with lung cancer.

SEC. 6. LUNG CANCER ADVISORY BOARD.

    (a) In General.--The Secretary of Health and Human Services shall 
establish a Lung Cancer Advisory Board (referred to in this section as 
the ``Board'') to monitor the programs established under this Act (and 
the amendments made by this Act), provide annual reports to Congress 
concerning benchmarks, expenditures, lung cancer statistics, and the 
public health impact of such programs.
    (b) Composition.--The Board shall be composed of--
            (1) the Secretary of Health and Human Services;
            (2) the Secretary of Defense;
            (3) the Secretary of Veterans Affairs; and
            (4) two representatives each from the fields of clinical 
        medicine focused on lung cancer, lung cancer research, imaging, 
        drug development, and lung cancer advocacy, to be appointed by 
        the Secretary of Health and Human Services.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out the programs under this Act (and 
the amendments made by this Act), there is authorized to be 
appropriated such sums as may be necessary for each of fiscal years 
2009 through 2013.