I 

108TH CONGRESS 

2D SESSION H. R. 5155 

To establish the National Institute for Biomedical Research and Development. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 28, 2004 

Mr. KUCINICH (for himself, Mr. OWENS, Mr. GRIJALVA, Mr. CONYERS, Ms. 

LEE, Mr. SERRANO, Mr. DAVIS of Illinois, and Mr. JACKSON of Illinois) 

introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To establish the National Institute for Biomedical Research 

and Development. 

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. 

4 This Act may be cited as the ‘‘Free Market Drug 

5 Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Prescription drugs are increasingly expen9 sive and unaffordable for the patients that need 

10 them. The Congressional Budget Office estimates 
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1 that drug costs have risen at a 19.1 percent annual 

2 rate over the last eight years and projects that they 

3 will rise at a 10.1 percent rate annual over the next 

4 decade. Drug prices are far higher in the United 

5 States than in any other developed country because 

6 it is the only country that grants pharmaceutical 

7 companies a monopoly in the market, based on pat8 ent protection, without any corresponding restriction 

9 on prices. 

10 (2) New pharmaceuticals are decreasing in 

11 number and quality. In 2002, 17 new drugs classi12 fied as new compounds were approved by the Food 

13 and Drug Administration (‘‘FDA’’), down from 24 

14 in 2001 and 27 in 2000. The vast majority of new 

15 drugs are not breakthrough cures, but rather copy16 cat drugs. According to the FDA, more than 70 per17 cent of new drugs approved in the last decade do not 

18 constitute qualitative improvements over existing 

19 treatments. 

20 (3) Pharmaceutical manufacturers have dis21 torted the quality of drug research in many in22 stances, such as with the drug Celebrex. Often due 

23 to the influence of the funding source, drug research 

24 has been shown to suffer from concealed and dis-
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1 torted findings, bias, conflicts of interest, and se2 crecy. 

3 SEC. 3. ESTABLISHMENT OF NATIONAL INSTITUTE FOR 

4 BIOMEDICAL RESEARCH AND DEVELOPMENT. 

5 Part C of title IV of the Public Health Service Act 

6 (42 U.S.C. 285 et seq.) is amended by adding at the end 

7 the following subpart: 

8 ‘‘Subpart 19—National Institute for Biomedical 

9 Research and Development 

10 ‘‘PURPOSE OF THE INSTITUTE

11 ‘‘SEC. 464z–1. (a) IN GENERAL.—The general pur12 pose of the National Institute for Biomedical Research 

13 and Development (in this section referred to as the ‘Insti14 tute’) is to provide in accordance with this section for the 

15 development of drugs, biological products, and devices, in16 cluding through Federal laboratories under subsection (f), 

17 in a manner that will foster an increase in the number 

18 and medical efficacy of drugs, biological products, and de19 vices on the market and will make the drugs, biological 

20 products, and devices available to the public at reasonable 

21 prices. 

22 ‘‘(b) IDENTIFICATION OF CANDIDATE DISCOV23 ERIES.—The Director shall monitor the results of research 

24 conducted or supported by the National Institutes of 

25 Health, and by other appropriate public or private entities, 
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1 in order to identify discoveries that, if subjected to appro2 priate research and development activities, may be suitable 

3 for the submission of applications for approval by the 

4 Food and Drug Administration as drugs, biological prod5 ucts, or devices for use in humans (referred to in this sec6 tion as ‘candidate discoveries’). 

7 ‘‘(c) RESEARCH AND OTHER ACTIVITIES REGARDING

8 CANDIDATE DISCOVERIES.— 

9 ‘‘(1) IN GENERAL.—The Director of the Insti10 tute shall conduct and support research, training, 

11 the dissemination of information, and other pro12 grams toward identifying candidate discoveries and 

13 carrying out appropriate research and development 

14 activities regarding such discoveries. 

15 ‘‘(2) ANNUAL PLAN.—The Director of the Insti16 tute shall establish, and annually review and as ap17 propriate revise, a plan for the development, testing, 

18 and manufacture of candidate discoveries through 

19 the Institute. 

20 ‘‘(3) AWARDS REGARDING RESEARCH AND DE21 VELOPMENT.—Each award of financial assistance 

22 under paragraph (1) for research and development 

23 activities shall be an award of a cooperative agree24 ment or a contract. 
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1 ‘‘(4) PRIORITIES.—In allocating the resources 

2 of the Institute, the Director of the Institute shall 

3 establish priorities among candidate discoveries. 

4 ‘‘(5) INTERNET SITE.—The Director of the In5 stitute shall maintain an Internet site to make avail6 able to the public information on activities under 

7 this section, including activities carried out by the 

8 Director and activities carried out under cooperative 

9 agreements or contracts under paragraph (1). Infor10 mation posted on such site shall be updated quar11 terly, or on such more frequent intervals as the Di12 rector determines to be appropriate. Such informa13 tion shall include the following: 

14 ‘‘(A) An identification of candidate discov15 eries that are receiving priority under para16 graph (4). 

17 ‘‘(B) All raw data developed under para18 graph (1) in carrying out research and develop19 ment activities. 

20 ‘‘(C) Findings made in carrying out such 

21 activities. 

22 ‘‘(d) PATENTS.— 

23 ‘‘(1) IN GENERAL.—The Director may identify 

24 a discovery as a candidate discovery only if the Fed25 eral Government holds, or can reasonably be ex-
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1 pected to obtain, a patent on the discovery. The Di2 rector may not transfer ownership of such patent to 

3 any non-Federal entity, notwithstanding any con4 flicting provision of chapter 18 of title 35, United 

5 States Code. 

6 ‘‘(2) CITIZENS’ SUITS FOR PROTECTION OF

7 FEDERAL OWNERSHIP OF PATENTS.— 

8 ‘‘(A) IN GENERAL.—Except as provided in 

9 subparagraph (C), any person may on his or 

10 her behalf commence a civil action in an appro11 priate district court of the United States 

12 against— 

13 ‘‘(i) any person in order to protect 

14 Federal ownership of patents on candidate 

15 discoveries; or 

16 ‘‘(ii) the Secretary where there is al17 leged a failure of the Secretary to protect 

18 Federal ownership of such patents. 

19 ‘‘(B) RELIEF.—In a civil action under sub20 paragraph (A), the district court involved may, 

21 as the case may be— 

22 ‘‘(i) enforce the compliance of a per23 son with provisions relating to Federal 

24 ownership of patents; or 
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1 ‘‘(ii) order the Secretary to perform 

2 an act or duty relating to such ownership. 

3 ‘‘(C) LIMITATIONS.— 

4 ‘‘(i) NOTICE TO SECRETARY.—A civil 

5 action may not be commenced under sub6 paragraph (A)(i) prior to 60 days after the 

7 plaintiff has provided to the Secretary no8 tice of the violation involved. 

9 ‘‘(ii) RELATION TO ACTIONS OF SEC10 RETARY.—A civil action may not be com11 menced under subparagraph (A)(ii) if the 

12 Secretary has commenced and is diligently 

13 prosecuting a civil action in a district court 

14 of the United States to protect the Federal 

15 ownership of the patent involved. 

16 ‘‘(D) RIGHT OF SECRETARY TO INTER17 VENE.—In any civil action under subparagraph 

18 (A), the Secretary, if not a party, may intervene 

19 as a matter of right. 

20 ‘‘(E) AWARD OF COSTS; FILING OF

21 BOND.—In a civil action under subparagraph 

22 (A), the district court involved may award costs 

23 of litigation (including reasonable attorney and 

24 expert witness fees) to any party whenever the 

25 court determines such an award is appropriate. 
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1 The court may, if a temporary restraining order 

2 or preliminary injunction is sought, require the 

3 filing of a bond or equivalent security in accord4 ance with the Federal Rules of Civil Procedure. 

5 ‘‘(F) SAVINGS PROVISION.—This para6 graph does not restrict any right that a person 

7 (or class of persons) may have under any stat8 ute or common law to seek enforcement of pro9 visions relating to Federal ownership of patents 

10 on candidate discoveries, or to seek any other 

11 relief (including relief against the Secretary). 

12 ‘‘(e) APPLICATION FOR APPROVAL BY FOOD AND

13 DRUG ADMINISTRATION.— 

14 ‘‘(1) IN GENERAL.—Each application submitted 

15 to the Food and Drug Administration for the ap16 proval of a candidate discovery, or for authorization 

17 to engage in investigational uses of the discovery, 

18 shall be submitted by the Director of the Institute 

19 or by a private entity. In the case of a private entity, 

20 such application shall be submitted pursuant to— 

21 ‘‘(A) a cooperative agreement or contract 

22 between the Director of the Institute and the 

23 private entity; and 

24 ‘‘(B) a nonexclusive license granted by the 

25 Director to the private entity for the commer-
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1 cial marketing of the discovery, notwithstanding 

2 any conflicting provision of chapter 18 of title 

3 35, United States Code. 

4 ‘‘(2) INSTITUTE AS HOLDER OF APPROVED AP5 PLICATION.—In the case of an application referred 

6 to in paragraph (1) that is submitted by the Direc7 tor of the Institute and approved by the Food and 

8 Drug Administration, the Director, promptly after 

9 such approval, shall seek to provide to one or more 

10 appropriate private entities nonexclusive licenses for 

11 the commercial marketing of the candidate discovery 

12 involved, notwithstanding any conflicting provision 

13 of chapter 18 of title 35, United States Code. 

14 ‘‘(f) FEDERAL LABORATORY SYSTEM.— 

15 ‘‘(1) IN GENERAL.—The Director of the Insti16 tute shall carry out this section directly and through 

17 Federal laboratories established by the Director in 

18 accordance with paragraph (2). 

19 ‘‘(2) CERTAIN REQUIREMENTS.—Subject to the 

20 extent of amounts made available in appropriations 

21 Acts, the Director shall establish 10 laboratories 

22 under paragraph (1). Each such laboratory shall be 

23 established within the National Institutes of Health, 

24 and shall be headed by an Associate Director, who 

25 shall be appointed by the Director of the Institute. 
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1 With respect to the location of the laboratories, the 

2 laboratories shall be equitably distributed among the 

3 various regions of the United States. 

4 ‘‘(3) TEN-YEAR PERFORMANCE REVIEW.— 

5 Promptly after the expiration of the ten-year period 

6 beginning on the date on which a Federal laboratory 

7 under paragraph (2) becomes operational (as deter8 mined by the Director), and every ten years there9 after, the Director of the Institute shall provide for 

10 a comprehensive review of the performance of the 

11 laboratory. The Director may, for good cause found 

12 pursuant to such a review, terminate the laboratory. 

13 If the laboratory is terminated, the Director of the 

14 Institute shall transfer the duties of the laboratory, 

15 and the funds and other assets of the laboratory, to 

16 the remaining laboratories under paragraph (2), and 

17 shall transfer within the Institute the officers and 

18 employees of the laboratory, or otherwise provide for 

19 the disposition of such officers and employees in ac20 cordance with applicable law. 

21 ‘‘(g) REWARDS FOR SIGNIFICANT ADVANCES.—The 

22 Director of the Institute shall establish a fund, consisting 

23 of amounts reserved under subsection (i)(2), from which 

24 the Director may provide cash awards to individuals or 

25 organizations that, in carrying out research and develop-
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1 ment activities under subsection (c), make significant ad2 vances in knowledge regarding a disease, disorder, or other 

3 health condition, including new treatments or diagnostic 

4 techniques. 

5 ‘‘(h) DEFINITIONS.—For purposes of this section: 

6 ‘‘(1) The term ‘biological product’ has the 

7 meaning that applies under section 351. 

8 ‘‘(2) The terms ‘drug’ and ‘device’ have the 

9 meanings given such terms under section 201 of the 

10 Federal Food, Drug, and Cosmetic Act. 

11 ‘‘(i) FUNDING.— 

12 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.— 

13 For the purpose of carrying out this section, there 

14 are authorized to be appropriated $19,930,000,000 

15 for fiscal year 2004, $20,400,000,000 for fiscal year 

16 2005, $20,910,000,000 for fiscal year 2006, 

17 $21,430,000,000 for fiscal year 2007, and 

18 $21,970,000,000 for fiscal year 2008. 

19 ‘‘(2) REWARDS FOR SIGNIFICANT ADVANCES.— 

20 Of the amounts appropriated under paragraph (1) 

21 for a fiscal year, the Director of the Institute shall 

22 reserve $50,000,000 for the fund under subsection 

23 (g).’’. 

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