II 

112TH CONGRESS 

1ST SESSION S. 362 

To amend the Public Health Service Act to provide for a Pancreatic Cancer 

Initiative, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 16, 2011 

Mr. WHITEHOUSE (for himself, Mr. KERRY, Mr. BEGICH, Mr. LUGAR, Ms. 

COLLINS, Mr. INOUYE, and Mr. BROWN of Ohio) 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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; FINDINGS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Pancreatic Cancer Research and Education Act’’. 

6 (b) FINDINGS.—The Congress finds the following: 

7 (1) More than 43,000 Americans were expected 

8 to be diagnosed with pancreatic cancer in 2010 and 

9 36,800 were expected to die from the disease. The 


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1 incidence among African-Americans is 40 to 50 per2 cent higher than other ethnic groups. 

3 (2) Pancreatic cancer is one of the few cancers 

4 for which survival has not improved substantially 

5 over the past 40 years. As a result, in 2003, pan6 creatic cancer surpassed prostate cancer as the 4th 

7 leading cause of cancer-related death in the United 

8 States. 

9 (3) Seventy-five percent of pancreatic cancer 

10 patients die within the first 12 months of the diag11 nosis. The 5-year survival rate is only 6 percent. 

12 (4) Scientific understanding of pancreatic can13 cer—its etiology, pathogenesis, detection, and treat14 ment—lags far behind that of most other forms of 

15 cancer. In fact, pancreatic cancer is the only of the 

16 top 10 cancer killers in the United States that still 

17 has a 5-year survival rate in the single digits. 

18 (5) In 2001, the National Cancer Institute de19 veloped ‘‘Pancreatic Cancer: An Agenda for Action’’. 

20 As of 2010, only five of the report’s 39 recommenda21 tions have been implemented because of a lack of 

22 funding, focus, and commitment. In the meantime, 

23 pancreatic cancer deaths have continued to increase. 

24 Further, according to the ‘‘Cancer Trends Progress 

25 Report–2009/2010 Update’’, death rates for panVerDate Mar 15 2010 02:51 Feb 17, 2011 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S362.IS S362

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1 creatic cancer are increasing while death rates for all 

2 cancers combined, including the four most common 

3 cancers (prostate, breast, lung, and colorectal), con4 tinue to decline. 

5 (6) Pancreatic cancer constitutes 2 percent of 

6 the National Cancer Institute’s Federal research 

7 funding, a figure far too low given the severity of the 

8 disease, its mortality rate, and how little is known 

9 about how to arrest the disease. 

10 (7) Of the more than 6,200 research grants 

11 awarded in fiscal year 2009 by the National Cancer 

12 Institute, only 272 (approximately 4 percent) were 

13 categorized by the Institute as at least 50 percent 

14 relevant to pancreatic cancer research. 

15 (8) The future supply of scientists entering this 

16 field of study is in serious jeopardy. Training grant 

17 (F, K, and T awards) funding in pancreatic cancer 

18 decreased by 15 percent from 2008 to 2009, a de19 cline larger than any of the other leading cancers ex20 perienced. Pancreatic cancer trainees were awarded 

21 between 2.4- and 6.5-fold less grant money in 2009 

22 than young researchers studying the other four top 

23 cancer killers. 

24 (9) In 2007, the Scientific Advisory Board of 

25 the Pancreatic Cancer Action Network reviewed the 


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1 current state of the science and the Federal Govern2 ment’s efforts on pancreatic cancer research and 

3 prepared ‘‘The National Plan to Advance Pancreatic 

4 Cancer Research’’ to identify the highest research 

5 priorities, scientific infrastructure needs, and work6 force training requirements that are needed to pro7 vide the answers that pancreatic cancer patients and 

8 their families and loved ones so desperately need. 

9 SEC. 2. PANCREATIC CANCER INITIATIVE. 

10 Part B of title III of the Public Health Service Act 

11 (42 U.S.C. 243 et seq.) is amended by adding at the end 

12 the following: 

13 ‘‘SEC. 320B. PANCREATIC CANCER INITIATIVE. 

14 ‘‘(a) PANCREATIC CANCER INITIATIVE.— 

15 ‘‘(1) ESTABLISHMENT.—The Secretary shall es16 tablish and implement a Pancreatic Cancer Initiative 

17 to assist in coordinating activities to address the 

18 high mortality rate associated with pancreatic can19 cer. Such Initiative shall focus on— 

20 ‘‘(A) advancing research on the causes, di21 agnosis, and treatment of pancreatic cancer 

22 with the goal of increasing the 5-year survival 

23 rate; 


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1 ‘‘(B) promoting a cadre of new investiga2 tors in the field of pancreatic cancer research; 

3 and 

4 ‘‘(C) increasing physician and public 

5 awareness of pancreatic cancer. 

6 ‘‘(2) CONSULTATION.—In carrying out this sub7 section, the Secretary shall consult with the Director 

8 of the National Institutes of Health, the Director of 

9 the National Cancer Institute, the Director of the 

10 Centers of Disease Control and Prevention, and the 

11 Interdisciplinary Pancreatic Cancer Coordinating 

12 Committee established under subsection (b). 

13 ‘‘(b) INTERDISCIPLINARY PANCREATIC CANCER CO14 ORDINATING COMMITTEE.— 

15 ‘‘(1) ESTABLISHMENT.—Not later than 60 days 

16 after the date of the enactment of this section, the 

17 Secretary, in consultation with the Director of the 

18 National Institutes of Health, shall establish a com19 mittee to be known as the Interdisciplinary Pan20 creatic Cancer Coordinating Committee (in this sub21 section referred to as the ‘Committee’). 

22 ‘‘(2) MEMBERSHIP.— 

23 ‘‘(A) IN GENERAL.—The members of the 

24 Committee shall be appointed by the Secretary, 

25 in consultation with the Director of the NaVerDate Mar 15 2010 02:51 Feb 17, 2011 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S362.IS S362

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1 tional Institutes of Health, and shall consist of 

2 13 individuals as follows: 

3 ‘‘(i) Nine experts in pancreatic cancer 

4 research, who are each a full professor at 

5 a major academic research institution and 

6 who have each received multiple grants 

7 from the National Cancer Institute or 

8 other entities of the National Institutes of 

9 Health with a primary focus on pancreatic 

10 cancer research. 

11 ‘‘(ii) Two new principal investigators 

12 in pancreatic cancer, who are each an as13 sistant-level professor in a major academic 

14 research institution and who have each re15 ceived at least one grant from the National 

16 Cancer Institute or another entity of the 

17 National Institutes of Health with a pri18 mary focus in pancreatic cancer research. 

19 ‘‘(iii) One pancreatic cancer advocate. 

20 ‘‘(iv) The Director of the National 

21 Cancer Institute (or the Director’s des22 ignee). 

23 ‘‘(B) CHAIR.—The Secretary shall des24 ignate the Chair of the Committee from among 

25 its members. 


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1 ‘‘(C) PUBLICATION OF NAMES.—Not later 

2 than 30 days after the establishment of the 

3 Committee, the Secretary shall publish the 

4 names of the Chair and members of the Com5 mittee on the Web site of the Department of 

6 Health and Human Services. 

7 ‘‘(D) TERMS.—The members of the Com8 mittee shall each be appointed for a 3-year term 

9 and, at the end of each such term, may be re10 appointed. 

11 ‘‘(E) VACANCIES.—A vacancy on the Com12 mittee shall be filled by the Secretary in the 

13 same manner in which the original appointment 

14 was made. 

15 ‘‘(3) RESPONSIBILITIES.—The Committee 

16 shall— 

17 ‘‘(A) provide advice on overall research ob18 jectives and benchmarks for pancreatic cancer 

19 research; 

20 ‘‘(B) not later than 6 months after the es21 tablishment of the Committee, and every 5 

22 years thereafter, develop a strategic plan in ac23 cordance with paragraph (4) for the conduct 

24 and support of pancreatic cancer research and 


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1 awareness during the upcoming 5-year period; 

2 and 

3 ‘‘(C) conduct evaluations and make rec4 ommendations to the Secretary, the Director of 

5 the National Institutes of Health, and the Di6 rector of the National Cancer Institute in ac7 cordance with paragraph (5) regarding the 

8 prioritization and award of National Institutes 

9 of Health research grants relating to pancreatic 

10 cancer. 

11 ‘‘(4) STRATEGIC PLAN.— 

12 ‘‘(A) DEVELOPMENT.—Not later than 6 

13 months after the establishment of the Com14 mittee, and every 5 years thereafter, the Com15 mittee shall develop a strategic plan for the 

16 conduct and support of pancreatic cancer re17 search and awareness during the upcoming 5- 

18 year period. 

19 ‘‘(B) SUBMISSION.—The Committee 

20 shall— 

21 ‘‘(i) submit to the Secretary each stra22 tegic plan developed under subparagraph 

23 (A) for the upcoming 5-year period; and 

24 ‘‘(ii) publish each such plan on the 

25 Web site of the Department of Health and 


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1 Human Services within 30 days after the 

2 date of submission of the plan to the Sec3 retary under clause (i). 

4 ‘‘(C) CONTENTS.—Each strategic plan de5 veloped under subparagraph (A) shall include— 

6 ‘‘(i) recommended budgetary require7 ments for pancreatic cancer research, in8 cluding research grants awarded through 

9 the National Cancer Institute, funding for 

10 Specialized Programs of Research Excel11 lence (SPORE) that are focused on pan12 creatic cancer, and funding for the portion 

13 of the cancer research incubator pilot 

14 project established by section 409J(a) that 

15 is focused on pancreatic cancer; 

16 ‘‘(ii) recommendations on the coordi17 nation of extramural and intramural pan18 creatic cancer research initiatives and pos19 sibilities for partnerships among the na20 tional research institutes, including the 

21 National Cancer Institute, the National In22 stitute of Diabetes and Digestive and Kid23 ney Diseases, the National Institute of En24 vironmental Health Sciences, the National 

25 Center for Complementary and Alternative 


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1 Medicine, and the National Center on Mi2 nority Health and Health Disparities; 

3 ‘‘(iii) recommendations for improving 

4 physician and public education about pan5 creatic cancer; 

6 ‘‘(iv) recommendations for increasing 

7 the number of scientists with doctorate de8 grees and clinician-scientists specializing in 

9 pancreatic cancer research; and 

10 ‘‘(v) guidelines for information gath11 ered by pancreatic cancer patient registries 

12 and tissue banks to ensure uniformity and 

13 accessibility to the research community. 

14 ‘‘(5) PRIORITIZATION AND AWARD OF NIH RE15 SEARCH GRANTS.— 

16 ‘‘(A) IN GENERAL.—The Committee shall 

17 conduct evaluations and make recommendations 

18 as needed to the Secretary, the Director of the 

19 National Institutes of Health, and the Director 

20 of the National Cancer Institute regarding the 

21 prioritization and award of National Institutes 

22 of Health research grants relating to pancreatic 

23 cancer. 

24 ‘‘(B) PEER REVIEW COMMITTEE.—In car25 rying out subparagraph (A), the Committee 


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1 may appoint a peer review committee to assist 

2 in the evaluation of pancreatic cancer grant ap3 plications to ensure that such applications are 

4 reviewed by individuals with the appropriate ex5 pertise. 

6 ‘‘(C) EVALUATION.—In evaluating pan7 creatic cancer grant applications under sub8 paragraph (A), the Committee shall emphasize 

9 grants that achieve at least one of the following 

10 goals: 

11 ‘‘(i) The grant is determined to be 

12 predominantly relevant to pancreatic can13 cer research and has a primary focus on at 

14 least one of the following areas: 

15 ‘‘(I) Basic research to advance 

16 the understanding of the biology of 

17 pancreatic cancer, its natural history, 

18 and the genetic and environmental 

19 factors that contribute to its develop20 ment. 

21 ‘‘(II) Research on more precise 

22 diagnostic methods and screening to 

23 detect pancreatic cancer in earlier 

24 stages. 


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1 ‘‘(III) Advanced innovative clin2 ical trials testing targeted thera3 peutics and novel agents that will ex4 tend the survival of pancreatic cancer 

5 patients and improve their quality of 

6 life. 

7 ‘‘(ii) The grant will increase the num8 ber of new pancreatic cancer investigators. 

9 ‘‘(iii) The grant will meet identified 

10 needs, criteria, or specific research goals 

11 set forth in the strategic plan developed 

12 under paragraph (3)(B). 

13 ‘‘(D) RECOMMENDATIONS.—The Com14 mittee shall make recommendations for excep15 tion funding for grant applications that— 

16 ‘‘(i) are predominantly relevant to 

17 pancreatic cancer; and 

18 ‘‘(ii) score within 10 points of the 

19 payline. 

20 ‘‘(c) PHYSICIAN AWARENESS.— 

21 ‘‘(1) PROGRAM.—The Secretary, in consultation 

22 with the Director of the National Institutes of 

23 Health, the Director of the Centers for Disease Con24 trol and Prevention, and relevant patient advocate 

25 and physician organizations, shall develop a primary 


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1 care provider education program on pancreatic can2 cer. The Secretary may include in such program ac3 credited continuing medical education and such 

4 other activities as the Secretary determines appro5 priate. 

6 ‘‘(2) DEFINITION.—The term ‘relevant patient 

7 advocate and physician organization’ means a na8 tionwide organization that— 

9 ‘‘(A) provides evidence-based disease infor10 mation to the public in a case management 

11 style; 

12 ‘‘(B) directly funds research in an unbi13 ased manner by working collaboratively with 

14 health professionals at a variety of institutions 

15 and using a peer-reviewed process; 

16 ‘‘(C) advocates public policy outcomes that 

17 reflect the needs of patients; and 

18 ‘‘(D) provides information to patients, 

19 families, and health professionals at the com20 munity level. 

21 ‘‘(d) COMMUNICATION TOOL KIT.—The Director of 

22 the National Cancer Institute and the Director of the Cen23 ters for Disease Control and Prevention, working collabo24 ratively with patient advocate organizations, shall develop 

25 a communication tool kit for patients and their families 


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1 that focuses on specific pancreatic cancer issues related 

2 to patient choices and patient care. 

3 ‘‘(e) REPORT TO CONGRESS.—Not later than 1 year 

4 after the date of the enactment of this section, and annu5 ally thereafter, the Secretary shall submit a report to the 

6 Congress identifying the steps taken to implement the 

7 Pancreatic Cancer Initiative under subsection (a). The re8 port shall include— 

9 ‘‘(1) an assessment of the progress in improv10 ing outcomes and reducing mortality rates for those 

11 diagnosed with pancreatic cancer; 

12 ‘‘(2) an explanation of how recommendations of 

13 the Interdisciplinary Pancreatic Cancer Coordinating 

14 Committee in the strategic plan developed under 

15 subsection (b)(3)(B) for the preceding year have 

16 been implemented; 

17 ‘‘(3) a summary of the recommendations that 

18 were made by the Interdisciplinary Pancreatic Can19 cer Coordinating Committee for grant funding, in20 cluding exception funding, the number of such rec21 ommendations that were met, and the reasons why 

22 any recommendations were not met; 

23 ‘‘(4) a breakdown of research grant award 

24 amounts by the National Institutes of Health during 

25 the past year that are deemed relevant to pancreatic 


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1 cancer research along with a quantifiable measure as 

2 to the relevancy of the grants to pancreatic cancer; 

3 ‘‘(5) the number of such grants awarded to new 

4 principal investigators in pancreatic cancer described 

5 in subsection (b)(2)(A)(ii); and 

6 ‘‘(6) a summary of progress and deficiencies 

7 that were noted in pancreatic cancer research during 

8 the preceding year. 

9 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

10 are authorized to be appropriated— 

11 ‘‘(1) to carry out subsection (a), $140,000,000 

12 for fiscal year 2012 and such sums as may be nec13 essary for fiscal years 2013 through 2016; 

14 ‘‘(2) to carry out subsection (c), $2,000,000 for 

15 fiscal year 2012 and such sums as may be necessary 

16 for fiscal years 2013 through 2016; and 

17 ‘‘(3) to carry out subsection (d), $2,000,000 for 

18 fiscal year 2012 and such sums as may be necessary 

19 for fiscal years 2013 through 2016.’’. 

20 SEC. 3. NATIONAL INSTITUTES OF HEALTH RESEARCH. 

21 Part B of title IV of the Public Health Service Act 

22 (42 U.S.C. 284 et seq.) is amended by adding at the end 

23 the following: 


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1 ‘‘SEC. 409J. CANCER RESEARCH. 

2 ‘‘(a) CANCER RESEARCH INCUBATOR PILOT

3 PROJECT.— 

4 ‘‘(1) GRANTS.— 

5 ‘‘(A) IN GENERAL.—The Secretary may 

6 award grants to research institutions for use in 

7 developing innovative compounds or tech8 nologies for the prevention, early detection, or 

9 treatment of those cancers with 5-year survival 

10 rates of less than 50 percent. 

11 ‘‘(B) RELATION TO OTHER NIH GRANTS.— 

12 Subject to subparagraph (A), the Secretary 

13 shall encourage each recipient of a grant under 

14 this section to use the grant for research activi15 ties that may serve as a springboard for the re16 ceipt of other grants, including Specialized Pro17 grams of Research Excellence (SPORE) grants, 

18 from the National Institutes of Health and its 

19 national research institutes. 

20 ‘‘(2) GRANT PERIOD.—The period of a grant 

21 under this section shall be 5 years. 

22 ‘‘(3) FOCUS.—During the initial 5 fiscal years 

23 of carrying out this section, the Secretary shall focus 

24 on awarding grants for use in developing innovative 

25 compounds or technologies for the prevention, early 

26 detection, or treatment of pancreatic cancer. 


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1 ‘‘(4) REPORT.—Not later than 5 years after the 

2 date of the enactment of this section, the Secretary 

3 shall submit a report to the Congress evaluating the 

4 program under this section and making rec5 ommendations for expansion of the program to other 

6 cancers. 

7 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

8 To carry out this subsection, there are authorized to 

9 be appropriated $5,000,000 for fiscal year 2012 and 

10 such sums as may be necessary for fiscal years 2013 

11 through 2016. 

12 ‘‘(b) CENTERS OF EXCELLENCE.— 

13 ‘‘(1) DESIGNATION.—The Secretary may des14 ignate two additional Specialized Programs of Re15 search Excellence (SPOREs) focusing solely on pan16 creatic cancer research. In carrying out this para17 graph, the Secretary may choose to designate one or 

18 more satellite centers that augment the work of a 

19 previously designated Specialized Program of Re20 search Excellence. 

21 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

22 To carry out this subsection, there are authorized to 

23 be appropriated $20,000,000 for fiscal year 2012 


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1 and such sums as may be necessary for fiscal years 

2 2013 through 2016.’’. 

Æ 


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