< Back to S. 3320 (111th Congress, 2009–2010)

Text of the Pancreatic Cancer Research and Education Act

This bill was introduced on May 6, 2010, in a previous session of Congress, but was not enacted. The text of the bill below is as of May 6, 2010 (Introduced).

Source: GPO

II

111th CONGRESS

2d Session

S. 3320

IN THE SENATE OF THE UNITED STATES

May 6, 2010

introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act to provide for a Pancreatic Cancer Initiative, and for other purposes.

1.

Short title; findings

(a)

Short title

This Act may be cited as the Pancreatic Cancer Research and Education Act.

(b)

Findings

The Congress finds the following:

(1)

Nearly 42,500 Americans were expected to be diagnosed with pancreatic cancer in 2009 and nearly 35,250 were expected to die from the disease. The incidence among African-Americans is 40 to 50 percent higher than other ethnic groups.

(2)

Pancreatic cancer is one of the few cancers for which survival has not improved substantially over the past 40 years. As a result, in 2003, pancreatic cancer surpassed prostate cancer as the 4th leading cause of cancer-related death in the United States.

(3)

Seventy-six percent of pancreatic cancer patients die within the first 12 months of the diagnosis. The 5-year survival rate is 5 percent.

(4)

Scientific understanding of pancreatic cancer—its etiology, pathogenesis, detection, and treatment—lags far behind that of most other forms of cancer. In fact, pancreatic cancer research is where breast cancer research was in the 1930s—little understanding of the causes, no early detection, few effective treatments, and single-digit survival rates.

(5)

In 2001, the National Cancer Institute developed Pancreatic Cancer: An Agenda for Action. Nine years later, only five of the report’s 39 recommendations have been implemented because of a lack of funding, focus, and commitment. In the meantime, pancreatic cancer death rates have continued to increase. Further, according to the Cancer Trends Progress Report—2009/2010 Update, death rates for pancreatic cancer are increasing while death rates for all cancers combined, including the four most common cancers (prostate, breast, lung, and colorectal), continue to decline.

(6)

Pancreatic cancer research constitutes less than 2 percent of the National Cancer Institute’s Federal research funding, a figure far too low given the severity of the disease, its mortality rate, and how little is known about how to arrest the disease.

(7)

Of the more than 5,000 research grants awarded annually by the Nations Cancer Institute in 2006, only 134 (approximately 3 percent) were categorized by the Institute as at least 50 percent relevant to pancreatic cancer research.

(8)

The future supply of scientists entering this field of study is in serious jeopardy. Out of the researchers who received National Cancer Institute funding specifically for pancreatic cancer research in 2008, only 38 received funding totaling $500,000 or more, a level appropriate for senior scientists. By comparison, this level of funding was awarded to 273 breast cancer researchers, 129 prostate cancer researchers, and 121 colorectal cancer researchers. Further, in the last 3 years, the National Cancer Institute has awarded only 5 grants for training and supporting new principal investigators in pancreatic cancer.

(9)

In 2007, the Scientific Advisory Board of the Pancreatic Cancer Action Network reviewed the current state of the science and the Federal Government’s efforts on pancreatic cancer research and prepared The National Plan to Advance Pancreatic Cancer Research to identify the highest research priorities, scientific infrastructure needs, and workforce training requirements that are needed to provide the answers that pancreatic cancer patients and their families and loved ones so desperately need.

2.

Pancreatic Cancer Initiative

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by adding at the end the following:

320B.

Pancreatic Cancer Initiative

(a)

Pancreatic Cancer Initiative

(1)

Establishment

The Secretary shall establish and implement a Pancreatic Cancer Initiative to assist in coordinating activities to address the high mortality rate associated with pancreatic cancer. Such Initiative shall focus on—

(A)

advancing research on the causes, diagnosis, and treatment of pancreatic cancer with the goal of increasing the 5-year survival rate;

(B)

promoting a cadre of new investigators in the field of pancreatic cancer research; and

(C)

increasing physician and public awareness of pancreatic cancer.

(2)

Consultation

In carrying out this subsection, the Secretary shall consult with the Director of the National Institutes of Health, the Director of the National Cancer Institute, the Director of the Centers of Disease Control and Prevention, and the Interdisciplinary Pancreatic Cancer Coordinating Committee established under subsection (b).

(b)

Interdisciplinary Pancreatic Cancer Coordinating Committee

(1)

Establishment

Not later than 60 days after the date of the enactment of this section, the Secretary, in consultation with the Director of the National Institutes of Health, shall establish a committee to be known as the Interdisciplinary Pancreatic Cancer Coordinating Committee (in this subsection referred to as the Committee).

(2)

Membership

(A)

In general

The members of the Committee shall be appointed by the Secretary, in consultation with the Director of the National Institutes of Health, and shall consist of 13 individuals as follows:

(i)

Nine experts in pancreatic cancer research, who are each a full professor at a major academic research institution and who have each received multiple grants from the National Cancer Institute or other entities of the National Institutes of Health with a primary focus on pancreatic cancer research.

(ii)

Two young principal investigators in pancreatic cancer, who are each an assistant-level professor in a major academic research institution and who have each received at least one grant from the National Cancer Institute or another entity of the National Institutes of Health with a primary focus in pancreatic cancer research.

(iii)

One pancreatic cancer advocate.

(iv)

The Director of the National Cancer Institute (or the Director’s designee).

(B)

Chair

The Secretary shall designate the Chair of the Committee from among its members.

(C)

Publication of names

Not later than 30 days after the establishment of the Committee, the Secretary shall publish the names of the Chair and members of the Committee on the Website of the Department of Health and Human Services.

(D)

Terms

The members of the Committee shall each be appointed for a 3-year term and, at the end of each such term, may be reappointed.

(E)

Vacancies

A vacancy on the Committee shall be filled by the Secretary in the same manner in which the original appointment was made.

(3)

Responsibilities

The Committee shall—

(A)

provide advice on overall research objectives and benchmarks for pancreatic cancer research;

(B)

develop and annually update a strategic plan in accordance with paragraph (4) for the conduct and support of pancreatic cancer research awareness during the upcoming year; and

(C)

conduct evaluations and make recommendations to the Secretary, the Director of the National Institutes of Health, and the Director of the National Cancer Institute in accordance with paragraph (5) regarding the prioritization and award of National Institutes of Health research grants relating to pancreatic cancer.

(4)

Strategic plan

(A)

Development

The Committee shall develop and annually update a strategic plan for the conduct and support of pancreatic cancer research and awareness during the upcoming fiscal year.

(B)

Submission

The Committee shall—

(i)

submit to the Secretary each strategic plan developed under subparagraph (A) for the upcoming fiscal year; and

(ii)

publish each such plan on the Website of the Department of Health and Human Services within 30 days after the earlier of—

(I)

the date of submission of the plan to the Secretary under clause (i); or

(II)

June 1.

(C)

Contents

Each strategic plan developed under subparagraph (A) shall include—

(i)

recommended budgetary requirements for pancreatic cancer research, including research grants awarded through the National Cancer Institute, funding for Specialized Programs of Research Excellence (SPORE) that are focused on pancreatic cancer, and funding for the portion of the cancer research incubator pilot project established by section 409J(a) that is focused on pancreatic cancer;

(ii)

recommendations on the coordination of extramural and intramural pancreatic cancer research initiatives and possibilities for partnerships among the national research institutes, including the National Cancer Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Environmental Health Sciences, the National Center for Complementary and Alternative Medicine, and the National Center on Minority Health and Health Disparities;

(iii)

recommendations for improving physician and public education about pancreatic cancer;

(iv)

recommendations for increasing the number of scientists with doctorate degrees and clinician-scientists specializing in pancreatic cancer research; and

(v)

guidelines for information gathered by pancreatic cancer patient registries and tissue banks to ensure uniformity and accessibility to the research community.

(5)

Prioritization and award of NIH research grants

(A)

In general

The Committee shall conduct evaluations and make recommendations to the Secretary, the Director of the National Institutes of Health, and the Director of the National Cancer Institute regarding the prioritization and award of National Institutes of Health research grants relating to pancreatic cancer.

(B)

Peer review committee

In carrying out subparagraph (A), the Committee may appoint a peer review committee to assist in the evaluation of pancreatic cancer grant applications to ensure that such applications are reviewed by individuals with the appropriate expertise.

(C)

Evaluation

In evaluating pancreatic cancer grant applications under subparagraph (A), the Committee shall emphasize grants that achieve at least one of the following goals:

(i)

The grant is determined to be at least 75 percent relevant to pancreatic cancer research and has a primary focus on at least one of the following areas:

(I)

Basic research to advance the understanding of the biology of pancreatic cancer, its natural history, and the genetic and environmental factors that contribute to its development.

(II)

Research on more precise diagnostic methods and screening to detect pancreatic cancer in earlier stages.

(III)

Advanced innovative clinical trials testing targeted therapeutics and novel agents that will extend the survival of pancreatic cancer patients and improve their quality of life.

(ii)

The grant will increase the number of young pancreatic cancer investigators.

(iii)

The grant will meet identified needs, criteria, or specific research goals set forth in the strategic plan developed under paragraph (3)(B).

(D)

Recommendations

The Committee shall make recommendations for exception funding for grant applications that—

(i)

have 75 percent or greater relevance to pancreatic cancer; and

(ii)

score within 10 points of the payline.

(c)

Physician awareness

(1)

Program

The Secretary, in consultation with the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and relevant patient advocate and physician organizations, shall develop a primary care provider education program on pancreatic cancer. The Secretary may include in such program accredited continuing medical education and such other activities as the Secretary determines appropriate.

(2)

Definition

The term relevant patient advocate and physician organization means a nationwide organization that—

(A)

provides evidence-based disease information to the public in a case management style;

(B)

directly funds research in an unbiased manner by working collaboratively with health professionals at a variety of institutions and using a peer-reviewed grant mechanism;

(C)

advocates public policy outcomes that reflect the needs of patients; and

(D)

provides information to patients, families, and health professionals at the community level.

(d)

Communication tool kit

The Director of the National Institutes of Health and the Director of the Centers for Disease Control and Prevention, working collaboratively with patient advocate organizations, shall develop a communication tool kit for patients and their families that focuses on specific pancreatic cancer issues related to patient choices and patient care.

(e)

Report to Congress

Not later than 1 year after the date of the enactment of this section, and annually thereafter, the Secretary shall submit a report to the Congress identifying the steps taken to implement the Pancreatic Cancer Initiative under subsection (a). The report shall include—

(1)

an assessment of the progress in improving outcomes and reducing mortality rates for those diagnosed with pancreatic cancer;

(2)

an explanation of how recommendations of the Interdisciplinary Pancreatic Cancer Coordinating Committee in the strategic plan developed under subsection (b)(3)(B) for the preceding year have been implemented;

(3)

a summary of the recommendations that were made by the Interdisciplinary Pancreatic Cancer Coordinating Committee for grant funding, including exception funding, the number of such recommendations that were met, and the reasons why any recommendations were not met;

(4)

a breakdown of research grant award amounts by the National Institutes of Health during the past year that are deemed relevant to pancreatic cancer research along with a quantifiable measure as to the relevancy of the grants to pancreatic cancer;

(5)

the number of such grants awarded to young principal investigators in pancreatic cancer described in subsection (b)(2)(A)(ii); and

(6)

a summary of progress and deficiencies that were made in pancreatic cancer research during the preceding year.

(f)

Authorization of appropriations

There are authorized to be appropriated—

(1)

to carry out subsection (a), $140,000,000 for fiscal year 2011 and such sums as may be necessary for fiscal years 2012 through 2015;

(2)

to carry out subsection (c), $2,000,000 for fiscal year 2011 and such sums as may be necessary for fiscal years 2012 through 2015; and

(3)

to carry out subsection (d), $2,000,000 for fiscal year 2011 and such sums as may be necessary for fiscal years 2012 through 2015.

.

3.

National Institutes of Health research

Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:

409J.

Cancer research

(a)

Cancer research incubator pilot project

(1)

Grants

(A)

In general

The Secretary may award grants to research institutions for use in developing innovative compounds or technologies for the prevention, early detection, or treatment of those cancers with 5-year survival rates of less than 50 percent.

(B)

Relation to other NIH grants

Subject to subparagraph (A), the Secretary shall encourage each recipient of a grant under this section to use the grant for research activities that may serve as a springboard for the receipt of other grants, including Specialized Programs of Research Excellence (SPORE) grants, from the National Institutes of Health and its national research institutes.

(2)

Grant period

The period of a grant under this section shall be 5 years.

(3)

Focus

During the initial 5 fiscal years of carrying out this section, the Secretary shall focus on awarding grants for use in developing innovative compounds or technologies for the prevention, early detection, or treatment of pancreatic cancer.

(4)

Report

Not later than 5 years after the date of the enactment of this section, the Secretary shall submit a report to the Congress evaluating the program under this section and making recommendations for expansion of the program to other cancers.

(5)

Authorization of appropriations

To carry out this subsection, there are authorized to be appropriated $5,000,000 for fiscal year 2011 and such sums as may be necessary for fiscal years 2012 through 2015.

(b)

Centers of excellence

(1)

Designation

The Secretary may designate two additional Specialized Programs of Research Excellence (SPOREs) focusing solely on pancreatic cancer research. In carrying out this paragraph, the Secretary may choose to designate one or more satellite centers that augment the work of a previously designated Specialized Program of Research Excellence.

(2)

Authorization of appropriations

To carry out this subsection, there are authorized to be appropriated $20,000,000 for fiscal year 2011 and such sums as may be necessary for fiscal years 2012 through 2015.

.