IC 

115TH CONGRESS 

1ST SESSION S. 204 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 4, 2017 

Referred to the Committee on Energy and Commerce 

AN ACT 

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, 

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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Trickett Wendler, 

3 Frank Mongiello, Jordan McLinn, and Matthew Bellina 

4 Right to Try Act of 2017’’. 

5 SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY 

6 PATIENTS DIAGNOSED WITH A TERMINAL 

7 ILLNESS. 

8 (a) IN GENERAL.—Chapter V of the Federal Food, 

9 Drug, and Cosmetic Act is amended by inserting after sec10 tion 561A (21 U.S.C. 360bbb–0) the following: 

11 ‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGI12 BLE PATIENTS. 

13 ‘‘(a) DEFINITIONS.—For purposes of this section— 

14 ‘‘(1) the term ‘eligible patient’ means a pa15 tient— 

16 ‘‘(A) who has been diagnosed with a life17 threatening disease or condition (as defined in 

18 section 312.81 of title 21, Code of Federal Reg19 ulations (or any successor regulations)); 

20 ‘‘(B) who has exhausted approved treat21 ment options and is unable to participate in a 

22 clinical trial involving the eligible investigational 

23 drug, as certified by a physician, who— 

24 ‘‘(i) is in good standing with the phy25 sician’s licensing organization or board; 

26 and 

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1 ‘‘(ii) will not be compensated directly 

2 by the manufacturer for so certifying; and 

3 ‘‘(C) who has provided to the treating phy4 sician written informed consent regarding the 

5 eligible investigational drug, or, as applicable, 

6 on whose behalf a legally authorized representa7 tive of the patient has provided such consent; 

8 ‘‘(2) the term ‘eligible investigational drug’ 

9 means an investigational drug (as such term is used 

10 in section 561)— 

11 ‘‘(A) for which a Phase 1 clinical trial has 

12 been completed; 

13 ‘‘(B) that has not been approved or li14 censed for any use under section 505 of this 

15 Act or section 351 of the Public Health Service 

16 Act; 

17 ‘‘(C)(i) for which an application has been 

18 filed under section 505(b) of this Act or section 

19 351(a) of the Public Health Service Act; or 

20 ‘‘(ii) that is under investigation in a clin21 ical trial that— 

22 ‘‘(I) is intended to form the primary 

23 basis of a claim of effectiveness in support 

24 of approval or licensure under section 505 

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1 of this Act or section 351 of the Public 

2 Health Service Act; and 

3 ‘‘(II) is the subject of an active inves4 tigational new drug application under sec5 tion 505(i) of this Act or section 351(a)(3) 

6 of the Public Health Service Act, as appli7 cable; and 

8 ‘‘(D) the active development or production 

9 of which is ongoing and has not been discon10 tinued by the manufacturer or placed on clinical 

11 hold under section 505(i); and 

12 ‘‘(3) the term ‘phase 1 trial’ means a phase 1 

13 clinical investigation of a drug as described in sec14 tion 312.21 of title 21, Code of Federal Regulations 

15 (or any successor regulations). 

16 ‘‘(b) EXEMPTIONS.—Eligible investigational drugs 

17 provided to eligible patients in compliance with this section 

18 are exempt from sections 502(f), 503(b)(4), 505(a), and 

19 505(i) of this Act, section 351(a) of the Public Health 

20 Service Act, and parts 50, 56, and 312 of title 21, Code 

21 of Federal Regulations (or any successor regulations), pro22 vided that the sponsor of such eligible investigational drug 

23 or any person who manufactures, distributes, prescribes, 

24 dispenses, introduces or delivers for introduction into 

25 interstate commerce, or provides to an eligible patient an 

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1 eligible investigational drug pursuant to this section is in 

2 compliance with the applicable requirements set forth in 

3 sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code 

4 of Federal Regulations (or any successor regulations) that 

5 apply to investigational drugs. 

6 ‘‘(c) USE OF CLINICAL OUTCOMES.— 

7 ‘‘(1) IN GENERAL.—Notwithstanding any other 

8 provision of this Act, the Public Health Service Act, 

9 or any other provision of Federal law, the Secretary 

10 may not use a clinical outcome associated with the 

11 use of an eligible investigational drug pursuant to 

12 this section to delay or adversely affect the review or 

13 approval of such drug under section 505 of this Act 

14 or section 351 of the Public Health Service Act un15 less— 

16 ‘‘(A) the Secretary makes a determination, 

17 in accordance with paragraph (2), that use of 

18 such clinical outcome is critical to determining 

19 the safety of the eligible investigational drug; or 

20 ‘‘(B) the sponsor requests use of such out21 comes. 

22 ‘‘(2) LIMITATION.—If the Secretary makes a 

23 determination under paragraph (1)(A), the Sec24 retary shall provide written notice of such deter25 mination to the sponsor, including a public health 

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1 justification for such determination, and such notice 

2 shall be made part of the administrative record. 

3 Such determination shall not be delegated below the 

4 director of the agency center that is charged with 

5 the premarket review of the eligible investigational 

6 drug. 

7 ‘‘(d) REPORTING.— 

8 ‘‘(1) IN GENERAL.—The manufacturer or spon9 sor of an eligible investigational drug shall submit to 

10 the Secretary an annual summary of any use of such 

11 drug under this section. The summary shall include 

12 the number of doses supplied, the number of pa13 tients treated, the uses for which the drug was made 

14 available, and any known serious adverse events. 

15 The Secretary shall specify by regulation the dead16 line of submission of such annual summary and may 

17 amend section 312.33 of title 21, Code of Federal 

18 Regulations (or any successor regulations) to require 

19 the submission of such annual summary in conjunc20 tion with the annual report for an applicable inves21 tigational new drug application for such drug. 

22 ‘‘(2) POSTING OF INFORMATION.—The Sec23 retary shall post an annual summary report of the 

24 use of this section on the internet website of the 

25 Food and Drug Administration, including the nummstockstill on DSK30JT082PROD with BILLS

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1 ber of drugs for which clinical outcomes associated 

2 with the use of an eligible investigational drug pur3 suant to this section was— 

4 ‘‘(A) used in accordance with subsection 

5 (c)(1)(A); 

6 ‘‘(B) used in accordance with subsection 

7 (c)(1)(B); and 

8 ‘‘(C) not used in the review of an applica9 tion under section 505 of this Act or section 

10 351 of the Public Health Service Act.’’. 

11 (b) NO LIABILITY.— 

12 (1) ALLEGED ACTS OR OMISSIONS.—With re13 spect to any alleged act or omission with respect to 

14 an eligible investigational drug provided to an eligi15 ble patient pursuant to section 561B of the Federal 

16 Food, Drug, and Cosmetic Act and in compliance 

17 with such section, no liability in a cause of action 

18 shall lie against— 

19 (A) a sponsor or manufacturer; or 

20 (B) a prescriber, dispenser, or other indi21 vidual entity (other than a sponsor or manufac22 turer), unless the relevant conduct constitutes 

23 reckless or willful misconduct, gross negligence, 

24 or an intentional tort under any applicable 

25 State law. 

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1 (2) DETERMINATION NOT TO PROVIDE DRUG.— 

2 No liability shall lie against a sponsor manufacturer, 

3 prescriber, dispenser or other individual entity for its 

4 determination not to provide access to an eligible in5 vestigational drug under section 561B of the Fed6 eral Food, Drug, and Cosmetic Act. 

7 (3) LIMITATION.—Except as set forth in para8 graphs (1) and (2), nothing in this section shall be 

9 construed to modify or otherwise affect the right of 

10 any person to bring a private action under any State 

11 or Federal product liability, tort, consumer protec12 tion, or warranty law. 

13 SEC. 3. SENSE OF THE SENATE. 

14 It is the sense of the Senate that section 561B of 

15 the Federal Food, Drug, and Cosmetic Act, as added by 

16 section 2— 

17 (1) does not establish a new entitlement or 

18 modify an existing entitlement, or otherwise estab19 lish a positive right to any party or individual; 

20 (2) does not establish any new mandates, direc21 tives, or additional regulations; 

22 (3) only expands the scope of individual liberty 

23 and agency among patients, in limited cir24 cumstances; 

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1 (4) is consistent with, and will act as an alter2 native pathway alongside, existing expanded access 

3 policies of the Food and Drug Administration; 

4 (5) will not, and cannot, create a cure or effec5 tive therapy where none exists; 

6 (6) recognizes that the eligible terminally ill pa7 tient population often consists of those patients with 

8 the highest risk of mortality, and use of experi9 mental treatments under the criteria and procedure 

10 described in such section 561A involves an informed 

11 assumption of risk; and 

12 (7) establishes national standards and rules by 

13 which investigational drugs may be provided to ter14 minally ill patients. 

Passed the Senate August 3, 2017. 

Attest: JULIE E. ADAMS, 

Secretary. 

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