Sec. 7001. Lung cancer mortality reduction

1,280 words·~6 min read·/bill/118/s/4773/is/section-7001

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

It is the sense of the Congress that— lung cancer mortality reduction should be made a national public health priority; and 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. 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: Not later than 6 months after the date of the enactment of the Health Equity and Accountability Act of 2024 , 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 Institute on Minority Health and Health Disparities, the Administrator of the Environmental Protection Agency, and other members of the Lung Cancer Advisory Board established under section 7001(d) of the Health Equity and Accountability Act of 2024 , 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 2028.

The Program shall include at least the following: With respect to the National Institutes of Health— a strategic review and prioritization by the National Cancer Institute of research grants to achieve the goal specified in subsection (a); 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 such diseases; 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 program; and the provision of funds to enable the National Institute of Environmental Health Sciences to implement research programs relative to the lung cancer incidence.

With respect to the Food and Drug Administration— activities under section 529B of the Federal Food, Drug, and Cosmetic Act; and 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. With respect to the Centers for Disease Control and Prevention, the establishment of an early disease research and management program under section 1511. 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.

The promotion (including education) of lung cancer screening within minority and rural populations and the study of the effectiveness of efforts to increase such screening. 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. 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. .

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: 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 (as defined in section 526). A drug described in this subsection is— a chemoprevention drug for precancerous conditions of the lung; a drug for targeted therapeutic treatments, including any vaccine, for lung cancer; or a drug to curtail or prevent nicotine addiction. The Board established under section 7001(d) of the Health Equity and Accountability Act of 2024 shall monitor the program implemented under this section. . 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 529B, 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 . Title XV of the Public Health Service Act ( 42 U.S.C. 300k et seq. ) is amended by adding at the end the following: 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. . The Secretary of Defense and the Secretary of Veterans Affairs, each in coordination with the Secretary of Health and Human Services, shall engage— in the implementation within the Department of Defense and the Department of Veterans Affairs, as the case may be, of an early detection and disease management research program for members of the Armed Forces and veterans whose smoking history and exposure to carcinogens during service on active duty in the Armed Forces has increased their risk for lung cancer; and in the implementation of coordinated care programs for members of the Armed Forces and veterans diagnosed with lung cancer. The Secretary of Health and Human Services shall convene a Lung Cancer Advisory Board (referred to in this section as the Board )— to monitor the programs established under this section (and the amendments made by this section); and to provide annual reports to the Congress concerning benchmarks, expenditures, lung cancer statistics, and the public health impact of such programs. The Board shall be composed of— the Secretary of Health and Human Services; the Secretary of Defense; the Secretary of Veterans Affairs; and 2 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. To carry out this section (and the amendments made by this section), there are authorized to be appropriated $75,000,000 for fiscal year 2025 and such sums as may be necessary for each of fiscal years 2026 through 2028. The amounts appropriated under paragraph

(1)shall be allocated as follows: $25,000,000 for fiscal year 2025, and such sums as may be necessary for each of fiscal years 2026 through 2028, for the activities described in section 417H(b)(1)(B) of the Public Health Service Act, as added by subsection (b); $25,000,000 for fiscal year 2025, and such sums as may be necessary for each of fiscal years 2026 through 2028, for the activities described in section 417H(b)(1)(C) of the Public Health Service Act; $10,000,000 for fiscal year 2025, and such sums as may be necessary for each of fiscal years 2026 through 2028, for the activities described in section 417H(b)(1)(D) of the Public Health Service Act; and $15,000,000 for fiscal year 2025, and such sums as may be necessary for each of fiscal years 2026 through 2028, for the activities described in section 417H(b)(3) of the Public Health Service Act.