I 111th CONGRESS 1st Session H. R. 2112 IN THE HOUSE OF REPRESENTATIVES April 27, 2009 Mrs. Christensen (for herself, Mr. LoBiondo, Ms. Lee of California, Mr. Meeks of New York, Ms. Bordallo, Mr. Payne, Mr. Rangel, Mr. Bishop of Georgia, Mr. Hinojosa, Ms. Jackson-Lee of Texas, Ms. Kilpatrick of Michigan, and Mr. Lance) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services and Veterans’ Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To establish a comprehensive interagency response to reduce lung cancer mortality in a timely manner.

1.

Short title

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

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.

3.

Sense of Congress concerning investment in lung cancer research

It is the sense of the Congress 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.

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:

417G.

Lung Cancer Mortality Reduction Program

(a)

In General

Not later than 6 months after the date of the enactment of this section, 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 Commissioner of Food and Drugs, 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 be known as the Lung Cancer Mortality Reduction Program, to achieve a reduction of at least 25 percent in the mortality rate of lung cancer by 2015. (b)

Requirements

The Program 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 Lung Cancer Mortality Reduction 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 expedite the development of computer assisted diagnostic, surgical, treatment, and drug testing innovations to reduce lung cancer mortality, such as through expansion of the Institute’s Quantum Grant Program and Image-Guided Interventions programs; and (D)the provision of funds to enable the National Institute of Environmental Health Sciences to implement research programs relative to the lung cancer incidence. (2)With respect to the Food and Drug Administration— (A)activities under section 529 of the Federal Food, Drug, and Cosmetic Act; and (B)activities under section 561 of the Federal Food, Drug, and Cosmetic Act to expand access to investigational drugs and devices for the diagnosis, monitoring, or treatment of lung cancer. (3)With respect to the Centers for Disease Control and Prevention, the establishment of an early disease research and management 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 under this section 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 under this section with particular emphasis on the coordination of drug and other cessation treatments with early detection protocols.

. (b)

Federal Food, Drug, and Cosmetic Act

Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa et seq.) is amended by adding at the end the following:

529.

Drugs relating to lung cancer

(a)

In general

The provisions of this subchapter shall apply to a drug described in subsection (b) to the same extent and in the same manner as such provisions apply to a drug for a rare disease or condition. (b)

Qualified drugs

A drug described in this subsection is— (1)a chemoprevention drug for precancerous conditions of the lung; (2)a drug for a targeted therapeutic treatments, including any vaccine for, lung cancer; and (3)a drug to curtail or prevent nicotine addiction. (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 expanding access to drugs under section 529, 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. (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:

1511.

Early disease research and management program

The Secretary shall establish and implement an early disease research and management program targeted at the high incidence and mortality rates of lung cancer among minority and low-income populations.

.

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 417G; (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.

6.

Lung cancer advisory board

(a)

In General

The Secretary of Health and Human Services shall convene a Lung Cancer Advisory Board (referred to in this section as the Board)— (1)to monitor the programs established under this Act (and the amendments made by this Act); and (2)to provide annual reports to the 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.

7.

Authorization of appropriations

(a)

In general

To carry out this Act (and the amendments made by this Act), there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014. (b)

Lung Cancer Mortality Reduction Program

Of the amounts authorized to be appropriated by subsection (a), there are authorized to be appropriated— (1)$25,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2014, for the activities described in section 417G(b)(1)(B) of the Public Health Service Act, as added by section 4(a); (2)$25,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2014, for the activities described in section 417G(b)(1)(C) of such Act; (3)$10,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2014, for the activities described in section 417G(b)(1)(D) of such Act; and (4)$15,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2014, for the activities described in section 417G(b)(3) of such Act.