S204 ENR: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 U.S. Senate text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

One Hundred Fifteenth Congress of the United States of America2d SessionBegun and held at the City of Washington on Wednesday, the third day of January, two thousand and eighteenS. 204IN THE SENATE OF THE UNITED STATESAN ACTTo authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes.

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.

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:

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;(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 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.

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;(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 RepresentativesVice President of the United States and President of the Senate