H.R. 733 (112th): Recalcitrant Cancer Research Act of 2012

112th Congress, 2011–2013. Text as of Feb 16, 2011 (Introduced).

Status & Summary | PDF | Source: GPO

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112th CONGRESS

1st Session

H. R. 733

IN THE HOUSE OF REPRESENTATIVES

February 16, 2011

(for herself, Mr. Lance, and Mr. Reichert) introduced the following bill; which was referred to the Committee on Energy and Commerce

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)

More than 43,000 Americans were expected to be diagnosed with pancreatic cancer in 2010, and over 36,800 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-five percent of pancreatic cancer patients die within the first 12 months of the diagnosis. The 5-year survival rate is only 6 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 is the only one of the top ten cancer killers in the United States that still has a 5-year survival rate in the single digits.

(5)

In 2001, the National Cancer Institute developed Pancreatic Cancer: An Agenda for Action. As of 2010, only 5 of the report’s 39 recommendations have been implemented because of a lack of funding, focus, and commitment. In the meantime, pancreatic cancer deaths 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 4 most common cancers (prostate, breast, lung, and colorectal), continue to decline.

(6)

Pancreatic cancer research funding constitutes 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 6,200 research grants awarded in fiscal year 2009 by the National Cancer Institute, only 272 (approximately 4 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. Training grant (F, K, and T awards) funding in pancreatic cancer decreased by 15 percent from 2008 to 2009, a decline larger than that experienced by any of the other leading cancers. Pancreatic cancer trainees were awarded between 2.4- and 6.5-fold less grant money in 2009 than young researchers studying the other 4 top cancer killers.

(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 for 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 new 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 1 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 not later than 6 months after the Committee’s establishment and update not less than every 5 years thereafter a strategic plan in accordance with paragraph (4) for the conduct and support of pancreatic cancer research and awareness during the upcoming 5-year period; 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 not later than 6 months of the Committee’s establishment and update not less than every 5 years thereafter a strategic plan for the conduct and support of pancreatic cancer research and awareness during the upcoming fiscal 5-year period.

(B)

Submission

The Committee shall—

(i)

submit to the Secretary each strategic plan developed under subparagraph (A) for the upcoming 5-year period; and

(ii)

publish each such plan on the Website of the Department of Health and Human Services within 30 days after the date of submitting the plan to the Secretary under clause (i).

(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 as needed 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 predominantly 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 new 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)

are predominantly relevant 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 process;

(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 Cancer Institute 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 new principal investigators in pancreatic cancer described in subsection (b)(2)(A)(ii); and

(6)

a summary of progress and deficiencies that were noted 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 each of fiscal years 2012 through 2014, $154,000,000 for fiscal year 2015, and $159,000,000 for fiscal year 2016;

(2)

to carry out subsection (c), $2,000,000 for each of fiscal years 2012 through 2014, $2,225,000 for fiscal year 2015, and $2,300,000 for fiscal year 2016; and

(3)

to carry out subsection (d), $2,000,000 for each of fiscal years 2012 through 2014, $2,225,000 for fiscal year 2015, and $2,300,000 for fiscal year 2016.

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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:

409K.

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 each of fiscal years 2012 through 2014, $5,500,000 for fiscal year 2015, and $5,750,000 for fiscal year 2016.

(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 1 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 2012, $20,750,000 for fiscal year 2013, $21,500,000 for fiscal year 2014, $22,250,000 for fiscal year 2015, and $23,000,000 for fiscal year 2016.

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