,,ii #aaith ,,congress #b;d ,session ,s4 #dfih ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #h1 #bjbf,mr4 ,johnson 7for himself and ,mr4 ,tuberville7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to authorize the use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or severely debilitating illness1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,right to ,try for ,individualized ,treatments ,act4 #b4 ,use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or severely debilitating illness 7a7 ,definitions ,section #efa;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7a77 is amended-- 7#a7 by amending paragraph 7#a7 to read as follows3 7#a7 the term eligible patient means-- 7,a7 in the case of a patient requesting an eligible investigational drug1 a patient who has-- 7i7 been diagnosed with a life-threatening disease or condition 7as defined in section #cab4ha of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7ii7 exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug1 as certified by a physician1 who-- 7,i7 is in good standing with the physician's licensing organization or board2 and 7,,ii7 will not be compensated directly by the manufacturer of such drug for so certifying2 and 7iii7 provided to the treating physician written informed consent regarding the eligible investigational drug1 or1 as applicable1 on whose behalf a legally authorized representative of the patient has provided such consent2 or 7,b7 in the case of a patient requesting an investigational individualized medical treatment1 a patient who has-- 7i7 been diagnosed with a life-threatening disease or condition or severely debilitating illness 7as such terms are defined in section #cab4ha of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7ii7 considered approved treatment options1 as certified by a physician1 who-- 7,i7 is in good standing with the physician's licensing organization or board2 7,,ii7 will not be compensated directly by the manufacturer of such treatment for so certifying2 and 7,,iii7 attests to the patient's life-threatening disease or condition or severely debilitating illness2 and 7iii7 provided to the treating physician-- 7,i7 written informed consent regarding the eligible investigational drug or1 as applicable1 on whose behalf a legally authorized representative of the patient has provided such consent2 or 7,,ii7 as applicable1 additional informed consent1 regarding the investigational individualized medical treatment1 or1 as applicable1 on whose behalf a legally authorized representative of the patient has provided such consent2 2 7#b7 in paragraph 7#b77;,d71 by striking and at the end2 7#c7 in paragraph 7#c71 by striking the period at the end and inserting a semicolon2 and 7#d7 by adding at the end the following3 7#d7 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 #dia7;a7 of the ,public ,health ,service ,act2 7#e7 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 profile1 including their genomic sequence1 human chromosomes1 deoxyribonucleic acid1 genes1 gene products 7such as enzymes and other types of proteins71 or metabolites2 and 7#f7 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-- 7,a7 an explanation of the currently approved treatments for the patient's disease or condition2 7,b7 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 life2 7,c7 clear identification of the specific proposed investigational individualized medical treatment the patient's physician recommends2 and 7,d7 a description1 based on the physician's knowledge of the proposed treatment and the patient's disease1 of the potential outcomes of the treatment4 4 7b7 ,eligibility for investigational individualized medical treatment ,section #efa;,b of such ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 is amended-- 7#a7 by redesignating subsections 7b7 through 7d7 as subsections 7c7 through 7e71 respectively2 and 7#b7 by inserting after subsection 7a7 the following3 7b7 ,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 treatment1 and an eligible patient may request access to such treatment from the eligible health care facility or manufacturer of such treatment1 consistent with the requirements of this section4 ,a manufacturer of an investigational individualized medical treatment is not required to make available such treatment to any patient4 4 7c7 ,exemptions ,section #efa;,b7c7 of such ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7c771 as redesignated by subsection 7b77#a7 of this section1 is amended-- 7#a7 by inserting and investigational individualized medical treatments after ,eligible investigational drugs2 7#b7 by inserting or investigational individualized medical treatment after such eligible investigational drug2 7#c7 by inserting or investigational individualized medical treatment after an eligible investigational drug2 and 7#d7 by inserting or investigational individualized medical treatments after investigational drugs4 7d7 ,conforming amendments ,section #efa;,b of such ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 is amended-- 7#a7 in the section heading1 by inserting and investigational individualized medical treatments after drugs2 and 7#b7 in subsection 7e77#b71 as redesignated by subsection 7b77#a7 of this section-- 7,a7 in subparagraph 7,a71 by striking subsection 7c77#a77;,a7 and inserting subsection 7d77#a77;,a72 and 7,b7 in subparagraph 7,b71 by striking subsection 7c77#a77;,b7 and inserting subsection 7d77#a77;,b74