II 

Calendar No. 367 

115TH CONGRESS 

2D SESSION H. R. 5247 

IN THE SENATE OF THE UNITED STATES 

MARCH 22, 2018 

Received 

MARCH 23 (legislative day, MARCH 22), 2018 

Read the first time 

APRIL 9, 2018 

Read the second time and placed on the calendar 

AN ACT 

To authorize the use of eligible investigational drugs by 

eligible patients who have been diagnosed with a stage 

of a disease or condition in which there is reasonable 

likelihood that death will occur within a matter of 

months, or with another eligible illness, and for other 

purposes. 


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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, 

5 Frank Mongiello, Jordan McLinn, and Matthew Bellina 

6 Right to Try Act of 2018’’. 

7 SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY 

8 PATIENTS DIAGNOSED WITH A TERMINAL 

9 ILLNESS. 

10 (a) IN GENERAL.—Subchapter E of chapter V of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb 

12 et seq.) is amended by inserting after section 561A (21 

13 U.S.C. 360bbb–0) the following: 

14 ‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGI15 BLE PATIENTS. 

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

17 ‘‘(1) The term ‘eligible patient’ means a pa18 tient— 

19 ‘‘(A) who has been diagnosed with an eligi20 ble illness; 

21 ‘‘(B) who has exhausted approved treat22 ment options and is not eligible to participate 

23 in (for a reason such as the patient not meeting 

24 inclusion criteria) a clinical trial designed to 

25 evaluate an investigational drug for the treatVerDate Sep 11 2014 22:43 Apr 09, 2018 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5247.PCS H5247

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1 ment of such eligible illness with which the pa2 tient has been diagnosed, including one involv3 ing the eligible investigational drug, or for 

4 whom participation in such a clinical trial is not 

5 feasible (for a reason such as a lack of geo6 graphic proximity to the clinical trial), as cer7 tified by a physician, who— 

8 ‘‘(i) is in good standing with the phy9 sician’s licensing organization or board; 

10 and 

11 ‘‘(ii) will not be compensated for so 

12 certifying; and 

13 ‘‘(C) who has provided to the treating phy14 sician written informed consent, as described in 

15 part 50 of title 21, Code of Federal Regulations 

16 (or any successor regulations), regarding the el17 igible investigational drug, or, as applicable, on 

18 whose behalf a legally authorized representative 

19 of the patient has provided such consent. 

20 ‘‘(2) The term ‘eligible investigational drug’ 

21 means an investigational drug (as such term is used 

22 in section 561)— 

23 ‘‘(A) for which a phase 1 clinical trial has 

24 been completed; 


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1 ‘‘(B) that has not been approved or li2 censed for any use under section 505 of this 

3 Act or section 351 of the Public Health Service 

4 Act; 

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

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

7 351(a) of the Public Health Service Act, as ap8 plicable, that is active; or 

9 ‘‘(ii) that is under investigation in a clin10 ical trial that— 

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

12 basis of a claim of effectiveness in support 

13 of approval or licensure under section 505 

14 of this Act or section 351 of the Public 

15 Health Service Act; and 

16 ‘‘(II) is the subject of an active inves17 tigational new drug application under sec18 tion 505(i) of this Act or section 351(a)(3) 

19 of the Public Health Service Act, as appli20 cable; and 

21 ‘‘(D) the active development or production 

22 of which— 

23 ‘‘(i) is ongoing; 

24 ‘‘(ii) has not been discontinued by the 

25 manufacturer; and 


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1 ‘‘(iii) is not the subject of a clinical 

2 hold under the regulations implementing 

3 section 505(i) or section 351(a)(3) of the 

4 Public Health Service Act, as applicable. 

5 ‘‘(3) The term ‘phase 1 trial’ means a phase 1 

6 clinical investigation of a drug as described in sec7 tion 312.21 of title 21, Code of Federal Regulations 

8 (or any successor regulations). 

9 ‘‘(4) The term ‘eligible illness’ means— 

10 ‘‘(A) a stage of a disease or condition in 

11 which there is reasonable likelihood that death 

12 will occur within a matter of months; or 

13 ‘‘(B) a disease or condition that would re14 sult in significant irreversible morbidity that is 

15 likely to lead to severely premature death. 

16 ‘‘(b) ALTERNATIVE PATHWAY FOR ELIGIBLE PA17 TIENTS WITH A TERMINAL ILLNESS.— 

18 ‘‘(1) IN GENERAL.—Eligible investigational 

19 drugs provided to eligible patients in compliance 

20 with this section are exempt from sections 502(f), 

21 503(b)(4), and subsections (a) and (i) of section 505 

22 of this Act, and section 351(a) of the Public Health 

23 Service Act so long as the conditions specified in 

24 paragraphs (2), (3), and (4) are met with respect to 

25 the provision of such investigational drugs. 


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1 ‘‘(2) COMPLIANCE WITH CERTAIN REGULA2 TIONS.—The conditions specified in this paragraph, 

3 with respect to an eligible investigational drug re4 ferred to in paragraph (1), are that— 

5 ‘‘(A) the eligible investigational drug is la6 beled in accordance with section 312.6 of title 

7 21, Code of Federal Regulations (or any suc8 cessor regulations); and 

9 ‘‘(B) the provision of such eligible inves10 tigational drug occurs in compliance with the 

11 applicable requirements set forth in sections 

12 312.7 and 312.8(d)(1) of title 21, Code of Fed13 eral Regulations (or any successor regulations) 

14 that apply to investigational drugs, subject to 

15 paragraph (5). 

16 ‘‘(3) NOTIFICATION.—The condition specified in 

17 this paragraph, with respect to an eligible investiga18 tional drug referred to in paragraph (1), is that the 

19 sponsor of such eligible investigational drug notifies 

20 the Secretary of the provision of such eligible inves21 tigational drug for use by an eligible patient pursu22 ant to this section. Such notification shall be sub23 mitted within 7 business days of the provision of 

24 such eligible investigational drug as correspondence 


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1 to the investigational new drug application described 

2 in subsection (a)(2). 

3 ‘‘(4) ADVERSE EVENT REPORTING.—The condi4 tion specified in this paragraph, with respect to an 

5 eligible investigational drug referred to in paragraph 

6 (1), is that the sponsor or manufacturer of such eli7 gible investigational drug has required, as a condi8 tion of providing the drug to a physician for use by 

9 an eligible patient pursuant to this section, that such 

10 physician will immediately report to such sponsor or 

11 manufacturer any serious adverse events, as such 

12 term is defined in section 312.32 of title 21, Code 

13 of Federal Regulations (or any successor regula14 tions), associated with the use of the eligible inves15 tigational drug by the eligible patient. 

16 ‘‘(5) APPLICATION.—For purposes of this sec17 tion, the requirements set forth in sections 312.7 

18 and 312.8(d)(1) of title 21 of the Code of Federal 

19 Regulations (or any successor regulations) are 

20 deemed to apply to any person who manufactures, 

21 distributes, prescribes, dispenses, introduces or deliv22 ers for introduction into interstate commerce, or 

23 provides to an eligible patient an eligible investiga24 tional drug pursuant to this section. 

25 ‘‘(c) USE OF CLINICAL OUTCOMES.— 


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

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

3 or any other provision of Federal law, the Secretary 

4 may not use a clinical outcome associated with the 

5 use of an eligible investigational drug pursuant to 

6 this section to delay or adversely affect the review or 

7 approval of such drug under section 505 of this Act 

8 or section 351 of the Public Health Service Act un9 less— 

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

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

12 such clinical outcome is critical to determining 

13 the safety of the eligible investigational drug; or 

14 ‘‘(B) the sponsor requests use of such out15 comes. 

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

17 determination under paragraph (1)(A), the Sec18 retary shall provide written notice of such deter19 mination to the sponsor, including a public health 

20 justification for such determination, and such notice 

21 shall be made part of the administrative record. 

22 Such determination shall not be delegated below the 

23 director of the agency center that is charged with 

24 the premarket review of the eligible investigational 

25 drug. 


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1 ‘‘(d) REPORTING.—The manufacturer or sponsor of 

2 an eligible investigational drug that provides an eligible 

3 investigational drug pursuant to this section shall post on 

4 the same publicly available internet website used by the 

5 manufacturer for purposes of section 561A(b) an annual 

6 summary of any provision by the manufacturer or sponsor 

7 of an eligible investigational drug under this section. The 

8 summary shall include the number of requests received, 

9 the number of requests granted, the number of patients 

10 treated, the therapeutic area of the drug made available, 

11 and any known or suspected serious adverse events, as 

12 such term is defined in section 312.32 of title 21, Code 

13 of Federal Regulations (or any successor regulations), as14 sociated with the use of the eligible investigational drug. 

15 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec16 tion shall be construed as limiting the authority of the Sec17 retary to require manufacturers or sponsors of investiga18 tional drugs to review and report information relevant to 

19 the safety of such investigational drug obtained or other20 wise received by the sponsor pursuant to part 312 of title 

21 21, Code of Federal Regulations (or successor regula22 tions).’’. 

23 (b) NO LIABILITY.—Section 561B of the Federal 

24 Food, Drug, and Cosmetic Act, as added by subsection 

25 (a), is amended by adding at the end the following: 


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1 ‘‘(f) LIABILITY.— 

2 ‘‘(1) ALLEGED ACTS OR OMISSIONS.— 

3 ‘‘(A) MANUFACTURER OR SPONSOR.—No 

4 manufacturer or sponsor (or their agent or rep5 resentative) of an investigational drug shall be 

6 liable for any alleged act or omission related to 

7 the provision of such drug to a single patient or 

8 small group of patients for treatment use in ac9 cordance with subsection (b) or (c) of section 

10 561 or the provision of an eligible investiga11 tional drug to an eligible patient in accordance 

12 with this section, including, with respect to the 

13 provision of an investigational drug under sec14 tion 561 or an eligible investigational drug 

15 under this section, the reporting of safety infor16 mation, from clinical trials or any other source, 

17 as required by section 312.32 of title 21, Code 

18 of Federal Regulations (or any successor regu19 lations). 

20 ‘‘(B) PHYSICIAN, CLINICAL INVESTIGATOR, 

21 OR HOSPITAL.— 

22 ‘‘(i) No licensed physician, clinical in23 vestigator, or hospital shall be liable for 

24 any alleged act or omission related to the 

25 provision of an investigational drug to a 


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1 single patient or small group of patients 

2 for treatment use in accordance with sub3 section (b) or (c) of section 561, as de4 scribed in clause (ii), or the provision of an 

5 eligible investigational drug to an eligible 

6 patient in accordance with this section, un7 less such act or omission constitutes on the 

8 part of such physician, clinical investigator, 

9 or hospital with respect to such investiga10 tional drug or eligible investigational 

11 drug— 

12 ‘‘(I) willful or criminal mis13 conduct; 

14 ‘‘(II) reckless misconduct; 

15 ‘‘(III) gross negligence relative to 

16 the applicable standard of care and 

17 practice with respect to the adminis18 tration or dispensing of such inves19 tigational drug; or 

20 ‘‘(IV) an intentional tort under 

21 applicable State law. 

22 ‘‘(ii) The requirements described in 

23 this clause are the requirements under 

24 subsection (b) or (c) of section 561, includ25 ing— 


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1 ‘‘(I) the reporting of safety infor2 mation, from clinical trials or any 

3 other source, as required by section 

4 312.32 of title 21, Code of Federal 

5 Regulations (or any successor regula6 tions); 

7 ‘‘(II) ensuring that the informed 

8 consent requirements of part 50 of 

9 title 21, Code of the Federal Regula10 tions (or any successor regulations) 

11 are met; and 

12 ‘‘(III) ensuring that review by an 

13 institutional review board is obtained 

14 in a manner consistent with the re15 quirements of part 56 of title 21, 

16 Code of the Federal Regulations (or 

17 any successor regulations). 

18 ‘‘(2) DETERMINATION NOT TO PROVIDE

19 DRUG.—No manufacturer, sponsor, licensed physi20 cian, clinical investigator, or hospital shall be liable 

21 for determining not to provide access to an inves22 tigational drug under this section or for dis23 continuing any such access that it initially deter24 mined to provide. 

25 ‘‘(3) LIMITATION.— 


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1 ‘‘(A) IN GENERAL.—Except as set forth in 

2 paragraphs (1) and (2), nothing in this section 

3 shall be construed to modify or otherwise affect 

4 the right of any person to bring a private action 

5 against a manufacturer or sponsor (or their 

6 agent or representative), physician, clinical in7 vestigator, hospital, prescriber, dispenser, or 

8 other entity under any State or Federal product 

9 liability, tort, consumer protection, or warranty 

10 law. 

11 ‘‘(B) FEDERAL GOVERNMENT.—Nothing in 

12 this section shall be construed to modify or oth13 erwise affect the authority of the Federal Gov14 ernment to bring suit under any Federal law.’’. 

Passed the House of Representatives March 21, 

2018. 

Attest: KAREN L. HAAS, 

Clerk. 


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Calendar No. 367 

115TH CONGRESS 

2D SESSION H. R. 5247 

AN ACT 

To authorize the use of eligible investigational 

other eligible illness, and for other purposes. will occur within a matter of months, or with anwhich there is reasonable likelihood that death nosed with a stage of a disease or condition in drugs by eligible patients who have been diagAPRIL 9, 2018 

Read the second time and placed on the calendar 


sradovich on DSK3GMQ082PROD with BILLS