I 

115TH CONGRESS 

1ST SESSION H. R. 878 

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 HOUSE OF REPRESENTATIVES 

FEBRUARY 6, 2017 

Mr. BIGGS (for himself, Mr. FITZPATRICK, Mr. CRAMER, Mr. GROTHMAN, Mr. 

MESSER, Mr. PITTENGER, Mr. STEWART, Mr. LANCE, Mr. OLSON, Mr. 

FRANKS of Arizona, Mr. LAMBORN, Mr. CARSON of Indiana, Ms. 

MCSALLY, Mr. YOHO, Mr. ROHRABACHER, Mr. DUNCAN of South Carolina, Mr. LEWIS of Minnesota, Mr. BARR, Mr. BRIDENSTINE, Mr. GOHMERT, Mr. BANKS of Indiana, Mr. SMUCKER, Mr. BRAT, Mr. SENSENBRENNER, Mr. SCHWEIKERT, Mr. MARINO, Mr. ROKITA, and Mr. ISSA) 

introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 

for a period to be subsequently determined by the Speaker, in each case 

for consideration of such provisions as fall within the jurisdiction of the 

committee concerned 

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 ‘‘Right to Try Act of 

5 2017’’. 


asabaliauskas on DSK3SPTVN1PROD with BILLS
2 

•HR 878 IH

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.— 


asabaliauskas on DSK3SPTVN1PROD with BILLS
3 

•HR 878 IH

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). 


asabaliauskas on DSK3SPTVN1PROD with BILLS
4 

•HR 878 IH

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’’ that— 

8 (A) has successfully completed a phase 1 

9 clinical investigation; 

10 (B) remains under investigation in a clin11 ical trial approved by the Food and Drug Ad12 ministration; and 

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

14 commercial distribution under section 505, 

15 510(k), or 515 of the Federal Food, Drug, and 

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

17 or section 351 of the Public Health Service Act 

18 (42 U.S.C. 262). 

19 (4) PHASE 1 CLINICAL INVESTIGATION.—The 

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

21 1 clinical investigation, as described in section 

22 312.21 of title 21, Code of Federal Regulations (or 

23 any successor regulations). 


asabaliauskas on DSK3SPTVN1PROD with BILLS
5 

•HR 878 IH

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 


asabaliauskas on DSK3SPTVN1PROD with BILLS