II 

115TH CONGRESS 

1ST SESSION S. 204 

To authorize the use of unapproved medical products by patients diagnosed 

with a terminal illness in accordance with State law, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 24, 2017 

Mr. JOHNSON (for himself, Mr. BARRASSO, Mr. BLUNT, Mr. BOOZMAN, Mrs. 

CAPITO, Mr. COCHRAN, Mr. CORKER, Mr. COTTON, Mr. CRAPO, Mr. 

CRUZ, Mr. DAINES, Mr. DONNELLY, Mr. ENZI, Mrs. FISCHER, Mr. 

FLAKE, Mr. GARDNER, Mr. GRAHAM, Mr. GRASSLEY, Mr. HATCH, Mr. 

HELLER, Mr. HOEVEN, Mr. INHOFE, Mr. ISAKSON, Mr. KENNEDY, Mr. 

KING, Mr. LANKFORD, Mr. LEE, Mr. MANCHIN, Mr. MCCAIN, Mr. 

MCCONNELL, Mr. MORAN, Ms. MURKOWSKI, Mr. PAUL, Mr. PERDUE, 

Mr. RISCH, Mr. ROUNDS, Mr. RUBIO, Mr. SASSE, Mr. SHELBY, Mr. SULLIVAN, Mr. TILLIS, Mr. TOOMEY, Mr. WICKER, and Mr. YOUNG) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To authorize the use of unapproved medical products by 

patients diagnosed with a terminal illness in accordance 

with State law, 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. 

4 This Act may be cited as the ‘‘Trickett Wendler Right 

5 to Try Act of 2017’’. 


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1 SEC. 2. USE OF UNAPPROVED MEDICAL PRODUCTS BY PA2 TIENTS DIAGNOSED WITH A TERMINAL ILL3 NESS. 

4 (a) IN GENERAL.—Notwithstanding the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 

6 the Controlled Substances Act (21 U.S.C. 801 et seq.), 

7 and any other provision of Federal law, the Federal Gov8 ernment shall not take any action to prohibit or restrict— 

9 (1) the production, manufacture, distribution, 

10 prescribing, or dispensing of an experimental drug, 

11 biological product, or device that— 

12 (A) is intended to treat a patient who has 

13 been diagnosed with a terminal illness; and 

14 (B) is authorized by, and in accordance 

15 with, State law; and 

16 (2) the possession or use of an experimental 

17 drug, biological product, or device— 

18 (A) that is described in subparagraphs (A) 

19 and (B) of paragraph (1); and 

20 (B) for which the patient has received a 

21 certification from a physician, who is in good 

22 standing with the physician’s certifying organi23 zation or board, that the patient has exhausted, 

24 or otherwise does not meet qualifying criteria to 

25 receive, any other available treatment options. 

26 (b) NO LIABILITY OR USE OF OUTCOMES.— 


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1 (1) NO LIABILITY.—Notwithstanding any other 

2 provision of law, no liability shall lie against a pro3 ducer, manufacturer, distributor, prescriber, dis4 penser, possessor, or user of an experimental drug, 

5 biological product, or device for the production, man6 ufacture, distribution, prescribing, dispensing, pos7 session, or use of an experimental drug, biological 

8 product, or device that is in compliance with sub9 section (a). 

10 (2) NO USE OF OUTCOMES.—Notwithstanding 

11 any other provision of law, the outcome of any pro12 duction, manufacture, distribution, prescribing, dis13 pensing, possession, or use of an experimental drug, 

14 biological product, or device that was done in com15 pliance with subsection (a) shall not be used by a 

16 Federal agency reviewing the experimental drug, bio17 logical product, or device to delay or otherwise ad18 versely impact review or approval of such experi19 mental drug, biological product, or device. 

20 (c) DEFINITIONS.—In this section: 

21 (1) BIOLOGICAL PRODUCT.—The term ‘‘biologi22 cal product’’ has the meaning given to such term in 

23 section 351 of the Public Health Service Act (42 

24 U.S.C. 262). 


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1 (2) DEVICE; DRUG.—The terms ‘‘device’’ and 

2 ‘‘drug’’ have the meanings given to such terms in 

3 section 201 of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 321). 

5 (3) EXPERIMENTAL DRUG, BIOLOGICAL PROD6 UCT, OR DEVICE.—The term ‘‘experimental drug, bi7 ological product, or device’’ means a drug, biological 

8 product, or device that— 

9 (A) has successfully completed a phase 1 

10 clinical investigation; 

11 (B) remains under investigation in a clin12 ical trial approved by the Food and Drug Ad13 ministration; and 

14 (C) is not approved, licensed, or cleared for 

15 commercial distribution under section 505, 

16 510(k), or 515 of the Federal Food, Drug, or 

17 Cosmetic Act (21 U.S.C. 355, 360(k), 360(e)) 

18 or section 351 of the Public Health Service Act 

19 (42 U.S.C. 262). 

20 (4) PHASE 1 CLINICAL INVESTIGATION.—The 

21 term ‘‘phase 1 clinical investigation’’ means a phase 

22 1 clinical investigation, as described in section 

23 312.21 of title 21, Code of Federal Regulations (or 

24 any successor regulations). 


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1 (5) TERMINAL ILLNESS.—The term ‘‘terminal 

2 illness’’ has the meaning given to such term in the 

3 State law specified in subsection (a)(1)(B). 

Æ 


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