[Congressional Record Volume 155, Number 16 (Tuesday, January 27, 2009)]
[Senate]
[Pages S896-S898]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself and Mr. Brownback):
  S. 332. A bill to establish a comprehensive interagency response to 
reduce lung cancer mortality in a timely manner; to the Committee on 
Health, Education, Labor, and Pensions.
  Mrs. FEINSTEIN. Mr. President, I rise to introduce the Lung Cancer 
Mortality Reduction Act, calling for a new effort to combat this often 
deadly form of cancer. I am pleased to be joined by Senator Brownback, 
the Co-Chair of

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the Senate Cancer Coalition, and a strong voice on a variety of cancer 
issues.
  This bill will renew and improve the Federal Government's efforts to 
combat lung cancer. It will affirm the goal of a 50 percent reduction 
in lung cancer mortality by 2015.
  It will authorize a Lung Cancer Mortality Reduction Program, with 
interagency coordination, to develop and implement a plan to meet this 
goal.
  It will authorize $75 million for lung cancer research programs in 
the National Heart Lung Blood Institute, National Institute of 
Biomedical Imaging and Bioengineering, National Institute of 
Environmental Health Sciences, and Centers for Disease Control.
  It will create a new incentive program in the Food and Drug 
Administration to be modeled on the Orphan Drug Act for the development 
of chemoprevention drugs for lung cancer and precancerous lung disease. 
These are drugs that could prevent precancer from progressing into 
full-blown disease.
  It will improve coordination disparity programs to ensure that the 
burdens of lung cancer on minority populations are addressed.
  We have made great strides against many types of cancer in the last 
several decades. However, these gains are uneven.
  When the National Cancer Act was passed in 1971, lung cancer had a 5-
year survival rate of only 12 percent. After decades of research 
efforts and scientific advances, this survival rate remains only 15 
percent. In contrast, the 5-year survival rates of breast, prostate, 
and colon cancer have risen to 89 percent, 99 percent and 65 percent 
respectively.
  A lung cancer diagnosis can be devastating. The average life 
expectancy following a lung cancer diagnosis is only 9 months.
  This is because far too many patients are not diagnosed with lung 
cancer until it has progressed to the later stages. Lung cancer can be 
hard to diagnose, and symptoms may at first appear to be other 
illnesses. As a result, only 16 percent of lung cancer patients are 
diagnosed when their cancer is still localized, and is the most 
treatable.

  Lung cancer still lacks early detection technology, to find cancer 
when it is most treatable. Mammograms can find breast cancer, and 
colonoscopies can find dangerous colon polyps. But there is no 
equivalent test for lung cancer at this time.
  Under this legislation, the National Cancer Institute has clear 
authority to work with other institutes on this early detection 
research. Coordination between all branches of the National Institutes 
of Health, including those with expertise on lungs, imaging, and cancer 
will be necessary to make this long overdue progress.
  Lung cancer lags behind other cancers, in part, due to stigma from 
smoking. Make no mistake, tobacco use causes the majority of lung 
cancer cases. Tobacco cessation is a critical component of reducing 
lung cancer mortality. Less smoking means less lung cancer. Period.
  But tobacco use does not fully explain lung cancer. Approximately 15 
percent of the people who die from lung cancer never smoked. A study 
published in the Journal of Clinical Oncology in 2007 tracked the 
incidence of lung cancer in 1 million people ages 40 to 79. It found 
that about 20 percent of female lung cancer patients were nonsmokers 
and 8 percent of male patients were nonsmokers.
  These patients may have been exposed to second hand smoke, or they 
may have been exposed to radon, asbestos, chromium, or other chemicals. 
There could be other causes and associations that have not yet been 
discovered, genetic predispositions or other environmental exposures.
  Dana Reeve put a face on these statistics, with her brave fight 
against lung cancer. Dana Reeve was a nonsmoker, and still was 
diagnosed with lung cancer at the age of 44. She died a mere 7 months 
later, leaving a young son.
  Dana Reeve's story shows that smoking cannot fully explain lung 
cancer. Everyone in this country could stop smoking today, and yet we 
would still face a lung cancer epidemic. According to the Lung Cancer 
Alliance, over 60 percent of new lung cancer cases occur in those who 
never smoked, or who quit smoking.
  I believe that we have the expertise and technology to make serious 
progress against this deadly cancer, and to reach the goal of halving 
lung cancer mortality by 2015.
  We need this legislation to ensure that our Government's resources 
are focused on this mission in the most efficient way possible.
  Agency efforts must be coordinated, and every part of the National 
Institutes of Health that may have some ideas to lend should be 
participating. That is what the Lung Cancer Mortality Reduction Program 
will accomplish.
  We can do better for Americans diagnosed with lung cancer. I ask my 
colleagues to support this legislation.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 332

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Lung Cancer Mortality 
     Reduction Act of 2009''.

     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 enactment of 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.
       (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 2016 and through 
     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 Services 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. 417G. 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 
     2009, the Secretary, in consultation with the Secretary of 
     Defense, the Secretary of Veterans Affairs, the Director of 
     the National Institutes of

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     Health, the Director of the Centers for Disease Control and 
     Prevention, the Commissioner of the Food and Drug 
     Administration, the Administrator 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 2009, shall 
     implement a comprehensive program to achieve a 50 percent 
     reduction in the mortality rate of lung cancer by 2016.
       ``(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 of 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 subchapter 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 2010 for the activities 
     described in subsection (b)(1)(B), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014;
       ``(2) $25,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(1)(C), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014;
       ``(3) $10,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(1)(D), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014; and
       ``(4) $15,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(3), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014.''.
       (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 to 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 2009 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 of part C of title IV of 
     the Public Health Service Act, as amended by section 4;
       (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), and 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--
       (A) clinical medicine focused on lung cancer;
       (B) lung cancer research;
       (C) imaging;
       (D) drug development; and
       (E) 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 2010 through 2014.
                                 ______