S. 204 

One Hundred Fifteenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Wednesday, 

the third day of January, two thousand and eighteen 

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. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

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

Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act 

of 2017’’. 

SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS 

DIAGNOSED WITH A TERMINAL ILLNESS. 

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

Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 

360bbb–0) the following: 

‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE 

PATIENTS. 

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

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

‘‘(A) who has been diagnosed with a life-threatening 

disease or condition (as defined in section 312.81 of title 

21, Code of Federal Regulations (or any successor regulations)); 

‘‘(B) who has exhausted approved treatment options 

and is unable to participate in a clinical trial involving 

the eligible investigational drug, as certified by a physician, 

who— 

‘‘(i) is in good standing with the physician’s 

licensing organization or board; and 

‘‘(ii) will not be compensated directly by the manufacturer for so certifying; and 

‘‘(C) who has provided to the treating physician written 

informed consent regarding the eligible investigational 

drug, or, as applicable, on whose behalf a legally authorized 

representative of the patient has provided such consent; 

‘‘(2) the term ‘eligible investigational drug’ means an investigational drug (as such term is used in section 561)— 

‘‘(A) for which a Phase 1 clinical trial has been completed; 

‘‘(B) that has not been approved or licensed for any 

use under section 505 of this Act or section 351 of the 

Public Health Service Act; 
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‘‘(C)(i) for which an application has been filed under 

section 505(b) of this Act or section 351(a) of the Public 

Health Service Act; or 

‘‘(ii) that is under investigation in a clinical trial that— 

‘‘(I) is intended to form the primary basis of a 

claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of 

the Public Health Service Act; and 

‘‘(II) is the subject of an active investigational new 

drug application under section 505(i) of this Act or 

section 351(a)(3) of the Public Health Service Act, as 

applicable; and 

‘‘(D) the active development or production of which 

is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and 

‘‘(3) the term ‘phase 1 trial’ means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, 

Code of Federal Regulations (or any successor regulations). 

‘‘(b) EXEMPTIONS.—Eligible investigational drugs provided to 

eligible patients in compliance with this section are exempt from 

sections 502(f), 503(b)(4), 505(a), and 505(i) of this Act, section 

351(a) of the Public Health Service Act, and parts 50, 56, and 

312 of title 21, Code of Federal Regulations (or any successor 

regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, 

dispenses, introduces or delivers for introduction into interstate 

commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the 

applicable requirements set forth in sections 312.6, 312.7, and 

312.8(d)(1) of title 21, Code of Federal Regulations (or any successor 

regulations) that apply to investigational drugs. 

‘‘(c) USE OF CLINICAL OUTCOMES.— 

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

this Act, the Public Health Service Act, or any other provision 

of Federal law, the Secretary may not use a clinical outcome 

associated with the use of an eligible investigational drug 

pursuant to this section to delay or adversely affect the review 

or approval of such drug under section 505 of this Act or 

section 351 of the Public Health Service Act unless— 

‘‘(A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome 

is critical to determining the safety of the eligible investigational drug; or 

‘‘(B) the sponsor requests use of such outcomes. 

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

under paragraph (1)(A), the Secretary shall provide written 

notice of such determination to the sponsor, including a public 

health justification for such determination, and such notice 

shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency 

center that is charged with the premarket review of the eligible 

investigational drug. 

‘‘(d) REPORTING.— 

‘‘(1) IN GENERAL.—The manufacturer or sponsor of an 

eligible investigational drug shall submit to the Secretary an 

annual summary of any use of such drug under this section. 

The summary shall include the number of doses supplied, the 
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number of patients treated, the uses for which the drug was 

made available, and any known serious adverse events. The 

Secretary shall specify by regulation the deadline of submission 

of such annual summary and may amend section 312.33 of 

title 21, Code of Federal Regulations (or any successor regulations) to require the submission of such annual summary in 

conjunction with the annual report for an applicable investigational new drug application for such drug. 

‘‘(2) POSTING OF INFORMATION.—The Secretary shall post 

an annual summary report of the use of this section on the 

internet website of the Food and Drug Administration, 

including the number of drugs for which clinical outcomes 

associated with the use of an eligible investigational drug 

pursuant to this section was— 

‘‘(A) used in accordance with subsection (c)(1)(A); 

‘‘(B) used in accordance with subsection (c)(1)(B); and 

‘‘(C) not used in the review of an application under 

section 505 of this Act or section 351 of the Public Health 

Service Act.’’. 

(b) NO LIABILITY.— 

(1) ALLEGED ACTS OR OMISSIONS.—With respect to any 

alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 

561B of the Federal Food, Drug, and Cosmetic Act and in 

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

shall lie against— 

(A) a sponsor or manufacturer; or 

(B) a prescriber, dispenser, or other individual entity 

(other than a sponsor or manufacturer), unless the relevant 

conduct constitutes reckless or willful misconduct, gross 

negligence, or an intentional tort under any applicable 

State law. 

(2) DETERMINATION NOT TO PROVIDE DRUG.—No liability 

shall lie against a sponsor manufacturer, prescriber, dispenser 

or other individual entity for its determination not to provide 

access to an eligible investigational drug under section 561B 

of the Federal Food, Drug, and Cosmetic Act. 

(3) LIMITATION.—Except as set forth in paragraphs (1) and 

(2), nothing in this section shall be construed to modify or 

otherwise affect the right of any person to bring a private 

action under any State or Federal product liability, tort, consumer protection, or warranty law. 

SEC. 3. SENSE OF THE SENATE. 

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

Food, Drug, and Cosmetic Act, as added by section 2— 

(1) does not establish a new entitlement or modify an 

existing entitlement, or otherwise establish a positive right 

to any party or individual; 

(2) does not establish any new mandates, directives, or 

additional regulations; 

(3) only expands the scope of individual liberty and agency 

among patients, in limited circumstances; 

(4) is consistent with, and will act as an alternative pathway alongside, existing expanded access policies of the Food 

and Drug Administration; 
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(5) will not, and cannot, create a cure or effective therapy 

where none exists; 

(6) recognizes that the eligible terminally ill patient population often consists of those patients with the highest risk 

of mortality, and use of experimental treatments under the 

criteria and procedure described in such section 561A involves 

an informed assumption of risk; and 

(7) establishes national standards and rules by which investigational drugs may be provided to terminally ill patients. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.