IN THE SENATE OF THE UNITED STATES
June 27, 2012
Mrs. Boxer (for herself and Mr. Kerry) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
To provide for research and education to improve screening, detection and diagnosis of prostate cancer.
This Act may be cited as
Prostate Cancer Detection Research
and Education Act.
Plan to develop and validate a test or tests for prostate cancer
The Secretary of Health and Human Services (referred to in this Act as the Secretary), acting through the Director of the National Institutes of Health, shall establish an advisory council on prostate cancer (referred to in this Act as the advisory council) to draft a plan for the development and validation of an accurate test or tests, such as biomarkers or imaging, to detect and diagnose prostate cancer.
The advisory council shall be comprised of the following experts:
A designee of the Centers for Disease Control and Prevention.
A designee of the Centers for Medicare & Medicaid Services.
A designee of the Office of the Director of the National Cancer Institute.
A designee of the Director of the Department of Defense Congressionally Directed Medical Research Program.
A designee of the Director of the National Institute of Biomedical Imaging and Bioengineering.
A designee of the Director of the National Institute of General Medical Sciences.
A designee of the Director of the National Institute on Minority Health and Health Disparities.
A designee of the Office of the Director of the National Institutes of Health.
A designee of the Food and Drug Administration.
A designee of the Agency for Healthcare Research and Quality.
A designee of the Director of the Telemedicine and Advanced Technology Research Center of the Department of Defense.
In addition to the members described in subparagraph (A), the advisory council shall include 8 expert members from outside the Federal Government to be appointed by the Secretary, which shall include—
2 prostate cancer patient advocates;
2 health care providers with a range of expertise and experience in prostate cancer; and
4 leading researchers with prostate cancer-related expertise in a range of clinical disciplines.
The advisory council shall meet quarterly and such meetings shall be open to the public.
The advisory council shall advise the Secretary, or the Secretary’s designee.
Not later than 1 year after the date of enactment of this Act, the advisory council shall provide to the Secretary, or the Secretary’s designee and Congress—
an initial evaluation of all Federally funded efforts in prostate cancer research relating to the development and validation of an accurate test or tests to detect and diagnose prostate cancer;
a plan for the development and validation of a reliable test or tests for the detection and accurate diagnosis of prostate cancer; and
a set of standards for prostate cancer screening, developed in coordination with the United States Preventive Services Task Force, to ensure that any tools for screening, detection, and diagnosis developed in accordance with the plan under subparagraph (B) will meet the requirements of the Task Force for recommendation as a proven preventive or diagnostic service.
The advisory council shall terminate on December 31, 2016.
The Secretary may make available $1,000,000 from amounts appropriated to the National Institutes of Health for each of fiscal years 2013 through 2017 to carry out this section.
Coordination and intensification of prostate cancer research
The Director of the National Institutes of Health, in consultation with the Secretary of Defense, shall coordinate and intensify research in accordance with the plan developed under section 2(b)(4)(B), with particular attention provided to leveraging existing research to develop and validate a test or tests, such as biomarkers or imaging, to detect and accurately diagnose prostate cancer in order to improve quality of life for millions of Americans, and decrease health care system costs.
The Secretary may make available $30,000,000 from amounts appropriated to the National Institutes of Health for each of fiscal years 2014 through 2018 to carry out this section.
Public awareness and education campaign
The Secretary, in coordination with the Director of the National Institutes of Health and the Director of the Centers for Disease Control and Prevention, shall carry out a national campaign to increase the awareness and knowledge of prostate cancer.
The national campaign conducted under subsection (a) shall include—
roles for the National Cancer Institute, the National Institute on Minority Health and Health Disparities, the Office on Minority Health of the Department of Health and Human Services, and the Office of Minority Health of the Centers for Disease Control and Prevention; and
the development and distribution of written educational materials, and the development and placing of public service announcements, that are intended to encourage men to seek prostate cancer screening when symptoms are present, when they have a family history of prostate cancer, or if they belong to a high-risk population.
In developing the national campaign under subsection (a), the Secretary shall recognize and address—
the racial disparities in the incidences of prostate cancer and mortality rates with respect to such disease; and
any barriers in access to patient care and participation in clinical trials that are specific to racial minorities.
The Secretary shall establish a program to award grants to nonprofit private entities to enable such entities to test alternative outreach and education strategies to increase the awareness and knowledge of Americans with respect to prostate cancer.
Authorization of appropriations
There is authorized to be appropriated to carry out this section, $5,000,000 for each of fiscal years 2013 through 2017.