II 

112TH CONGRESS 

2D SESSION S. 3506 

To eliminate requirements to undertake duplicative clinical testing of new 

pharmaceutical drugs, vaccines, biological products, or medical devices, 

when such duplication is inconsistent with relevant ethical norms. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 2, 2012 

Mr. SANDERS introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To eliminate requirements to undertake duplicative clinical 

testing of new pharmaceutical drugs, vaccines, biological 

products, or medical devices, when such duplication is 

inconsistent with relevant ethical norms. 

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 ‘‘Ethical Pathway Act 

5 of 2012’’. 

6 SEC. 2. PURPOSE. 

7 The purpose of this Act is to eliminate requirements 

8 to undertake duplicative clinical testing of new pharmamstockstill on DSK4VPTVN1PROD with BILLS

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1 ceutical drugs, vaccines, biological products or medical de2 vices, when such duplication is inconsistent with relevant 

3 ethical norms, by providing for the opportunity to rely 

4 upon existing trials, subject to sharing of the costs of 

5 those trials, during the period when regulatory test data 

6 is protected. 

7 SEC. 3. ETHICAL PATHWAY FOR THE APPROVAL AND LI8 CENSOR OF REGULATED PRODUCTS. 

9 (a) DEFINITIONS.—For purposes of this Act: 

10 (1) APPLICANT.—The term ‘‘applicant’’ means 

11 a person who submits to the Secretary an applica12 tion to sell a regulated product. 

13 (2) COMMISSIONER.—The term ‘‘Commis14 sioner’’ means the Commissioner of Food and 

15 Drugs. 

16 (3) REGULATED PRODUCT.—The term ‘‘regu17 lated product’’ includes any new pharmaceutical 

18 drug, vaccine, biologic product or medical device, 

19 that requires regulatory approval by the Secretary. 

20 (4) REGULATORY TEST DATA.—The term ‘‘reg21 ulatory test data’’ means the evidence regarding the 

22 safety and efficacy of new pharmaceutical drugs or 

23 biological products used in order to obtain marketing 

24 approval for use in humans or vertebrate animals. 

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1 (5) RELEVANT APPLICATION OR LICENSE.—The 

2 term ‘‘relevant application or license’’ means a new 

3 drug application or new biological product license 

4 application approved by the Secretary or relevant 

5 authority in a foreign country which contains regu6 latory test data requested by an applicant under this 

7 section. 

8 (6) SECRETARY.—The term ‘‘Secretary’’ means 

9 the Secretary of Health and Human Services. 

10 (b) ETHICAL PATHWAY.—As soon as practicable 

11 after the date of enactment of this Act, the Secretary, act12 ing through the Commissioner, shall establish a mecha13 nism by which an applicant may request a cost-sharing 

14 arrangement described in subsection (c). An applicant 

15 may request such an arrangement if, but for the arrange16 ment— 

17 (1) the applicant would be required to conduct 

18 clinical investigations involving human subjects that 

19 violate Article 20 of the Declaration of Helsinki on 

20 Ethical Principles for Medical Research Involving 

21 Human Subjects in order to obtain regulatory ap22 proval of a regulated product; or 

23 (2) the duplication of the clinical investigations 

24 required for such application would violate other apmstockstill on DSK4VPTVN1PROD with BILLS

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1 plicable ethical standards concerning the testing of 

2 products on humans or other vertebrate animals. 

3 (c) COST-SHARING ARRANGEMENT.— 

4 (1) RESPONSIBILITY OF APPLICANT.—An appli5 cant that intends to perform clinical investigations 

6 involving humans or vertebrate animals in order to 

7 file an application for a regulated product shall take 

8 all necessary measures to verify that those investiga9 tions have not been performed or initiated by an10 other person. 

11 (2) VOLUNTARY AGREEMENT PROCEDURES.— 

12 An applicant shall make reasonable efforts to obtain 

13 voluntary agreements to use existing regulatory test 

14 data, such as by offering to make contributions to15 ward the cost of undertaking such tests, which the 

16 applicant does not have the right to rely upon in the 

17 absence of a license or a cost-sharing agreement. 

18 (3) FAILURE TO REACH VOLUNTARY AGREE19 MENT.—The applicant shall notify the Commissioner 

20 or the appropriate designee of the Commissioner if 

21 there is a failure to reach a voluntary agreement to 

22 use such test data. Upon receipt of a notification of 

23 a failure to reach a voluntary agreement, the Com24 missioner or such designee shall ask the parties to 

25 agree to binding arbitration to determine the reasonmstockstill on DSK4VPTVN1PROD with BILLS

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1 able and fair fee for relying upon relevant regulatory 

2 test data. If one or more of the parties refuses to 

3 participate in such arbitration, the Commissioner 

4 shall determine a reasonable and fair fee for the reli5 ance by the applicant on such regulatory test data. 

6 (4) REASONABLE AND FAIR FEE.—The reason7 able and fair fee for the reliance by the applicant on 

8 the regulatory test data shall be determined after 

9 considering the following factors: 

10 (A) The actual out-of-pocket costs of the 

11 applicable clinical investigations. 

12 (B) The risks of the investigations, as re13 flected in the probabilities that similar inves14 tigations result in successful applications for 

15 marketing. 

16 (C) Any Federal grants, tax credits, or 

17 other subsidies that reduce the net cost of the 

18 investigations. 

19 (D) The expected share of the global mar20 ket for the product involved, by the party seek21 ing to rely upon the investigations for mar22 keting approval. 

23 (E) The amount of the time the holder or 

24 holders of the relevant applications or licenses 

25 has benefitted from exclusive rights, and the cumstockstill on DSK4VPTVN1PROD with BILLS

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1 mulative revenue earned on the products that 

2 relied upon the regulatory test data at issue. 

3 (d) PUBLIC DISCLOSURE.— 

4 (1) IN GENERAL.—In order to enhance the 

5 transparency of the costs of innovation, and to pro6 vide greater predictability as to the liability associ7 ated with nonvoluntary reliance upon regulatory test 

8 data, the Secretary shall adopt procedures and rules 

9 under which sufficient information about the costs 

10 and fees will be made public by the arbitrator or the 

11 Commissioner (or the appropriate designee of the 

12 Commissioner), as applicable. 

13 (2) CONTENT.—The information made public 

14 under paragraph (1) shall include at least summary 

15 data of the actual costs of the clinical investigations, 

16 the factors considered under subsection (c)(4), and 

17 the amount of the fee provided to the holder or hold18 ers of the relevant applications or licenses. 

19 (3) LIMITATIONS.—The requirements for public 

20 disclosure of the costs of the clinical investigations 

21 shall not apply to cases where the owner of the 

22 rights in the regulatory test data does not assert an 

23 exclusive right to rely upon such test data. If the 

24 owner of the rights in the regulatory test data as25 serts an exclusive right, but reaches a voluntary 

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1 agreement on the fee for relying upon the data 

2 under subsection (c)(2), the amount of the fee paid 

3 by the applicant shall be provided to the Secretary 

4 or a designee, and be made public. 

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