Use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or severely debilitating illness

(a)

Definitions

Section 561B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0a(a)) is amended—(1)by amending paragraph (1) to read as follows:

(1)the term eligible patient means—(A)in the case of a patient requesting an eligible investigational drug, a patient who has—(i)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));(ii)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 of such drug for so certifying; and(iii)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; or(B)in the case of a patient requesting an investigational individualized medical treatment, a patient who has—(i)been diagnosed with a life-threatening disease or condition or severely debilitating illness (as such terms are defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations));(ii)considered approved treatment options, as certified by a physician, who—(I)is in good standing with the physician’s licensing organization or board;(II)will not be compensated directly by the manufacturer of such treatment for so certifying; and(III)attests to the patient’s life-threatening disease or condition or severely debilitating illness; and(iii)provided to the treating physician—(I)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; or(II)as applicable, additional informed consent, regarding the investigational individualized medical treatment, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent;

;

(2)in paragraph (2)(D), by striking and at the end;(3)in paragraph (3), by striking the period at the end and inserting a semicolon; and(4)by adding at the end the following:

(4)the term eligible health care facility means a health care facility that is operating under the Federal assurance for protection of human subjects pursuant to section 491(a) of the Public Health Service Act; (5)the term investigational individualized medical treatment means a drug or biological product for the patient based on an analysis of the patient’s unique genomic profile, including their genomic sequence, human chromosomes, deoxyribonucleic acid, genes, gene products (such as enzymes and other types of proteins), or metabolites; and(6)the term additional informed consent means consent attested to in writing by the patient’s physician and a witness for an investigational individualized medical treatment that includes—(A)an explanation of the currently approved treatments for the patient’s disease or condition;(B)the patient’s attestation that the patient concurs with the assessment of their physician that all currently approved and conventionally recognized treatments are unlikely to prolong or improve their life;(C)clear identification of the specific proposed investigational individualized medical treatment the patient’s physician recommends; and(D)a description, based on the physician’s knowledge of the proposed treatment and the patient’s disease, of the potential outcomes of the treatment.

(b)

Eligibility for investigational individualized medical treatment

Section 561B of such Act (21 U.S.C. 360bbb–0a) is amended—(1)by redesignating subsections (b) through (d) as subsections (c) through (e), respectively; and(2)by inserting after subsection (a) the following:

(b)

Eligibility for investigational individualized medical treatment

A manufacturer of an investigational individualized medical treatment that is in compliance with all applicable Federal assurance laws and regulations and is operating within an eligible health care facility may make available such investigational individualized medical treatment, and an eligible patient may request access to such treatment from the eligible health care facility or manufacturer of such treatment, consistent with the requirements of this section. A manufacturer of an investigational individualized medical treatment is not required to make available such treatment to any patient.

(c)

Exemptions

Section 561B(c) of such Act (21 U.S.C. 360bbb–0a(c)), as redesignated by subsection (b)(1) of this section, is amended—(1)by inserting and investigational individualized medical treatments after Eligible investigational drugs;(2)by inserting or investigational individualized medical treatment after such eligible investigational drug;(3)by inserting or investigational individualized medical treatment after an eligible investigational drug; and(4)by inserting or investigational individualized medical treatments after investigational drugs.(d)

Conforming amendments

Section 561B of such Act (21 U.S.C. 360bbb–0a) is amended—(1)in the section heading, by inserting

and investigational individualized medical treatments

after

drugs

; and(2)in subsection (e)(2), as redesignated by subsection (b)(1) of this section—(A)in subparagraph (A), by striking subsection (c)(1)(A) and inserting subsection (d)(1)(A); and(B)in subparagraph (B), by striking subsection (c)(1)(B) and inserting subsection (d)(1)(B).