,,ii ,calendar ,no4 #cfg #aaeth ,,congress #b;d ,session ,h4 ,r4 #ebdg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #bb1 #bjah,received ,march #bc 7legislative day1 ,march #bb71 #bjah,read the first time ,april #i1 #bjah,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 months1 or with another eligible illness1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,trickett ,wendler1 ,frank ,mongiello1 ,jordan ,mc,linn1 and ,matthew ,bellina ,right to ,try ,act of #bjah4 #b4 ,use of unapproved investigational drugs by patients diagnosed with a terminal illness 7a7 ,in general ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by inserting after section #efa;,a 7#ba ,u4,s4,c4 #cfj;bbb-#j7 the following3 #efa;,b4 ,investigational drugs for use by eligible patients 7a7 ,definitions ,for purposes of this section3 7#a7 ,the term eligible patient means a patient-- 7,a7 who has been diagnosed with an eligible illness2 7,b7 who has exhausted approved treatment options and is not eligible to participate in 7for a reason such as the patient not meeting inclusion criteria7 a clinical trial designed to evaluate an investigational drug for the treatment of such eligible illness with which the patient has been diagnosed1 including one involving the eligible investigational drug1 or for whom participation in such a clinical trial is not feasible 7for a reason such as a lack of geographic proximity to the clinical trial71 as certified by a physician1 who-- 7i7 is in good standing with the physician's licensing organization or board2 and 7ii7 will not be compensated for so certifying2 and 7,c7 who has provided to the treating physician written informed consent1 as described in part #ej of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 regarding the eligible investigational drug1 or1 as applicable1 on whose behalf a legally authorized representative of the patient has provided such consent4 7#b7 ,the term eligible investigational drug means an investigational drug 7as such term is used in section #efa7-- 7,a7 for which a phase #a clinical trial has been completed2 7,b7 that has not been approved or licensed for any use under section #eje of this ,act or section #cea of the ,public ,health ,service ,act2 7,c7 7i7 for which an application has been filed under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 as applicable1 that is active2 or 7ii7 that is under investigation in a clinical trial that-- 7,i7 is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section #eje of this ,act or section #cea of the ,public ,health ,service ,act2 and 7,,ii7 is the subject of an active investigational new drug application under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act1 as applicable2 and 7,d7 the active development or production of which-- 7i7 is ongoing2 7ii7 has not been discontinued by the manufacturer2 and 7iii7 is not the subject of a clinical hold under the regulations implementing section #eje7;i7 or section #cea7;a77#c7 of the ,public ,health ,service ,act1 as applicable4 7#c7 ,the term phase #a trial means a phase #a clinical investigation of a drug as described in section #cab4ba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7#d7 ,the term eligible illness means-- 7,a7 a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months2 or 7,b7 a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death4 7b7 ,alternative pathway for eligible patients with a terminal illness 7#a7 ,in general ,eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections #ejb7;f71 #ejc7;b77#d71 and subsections 7a7 and 7i7 of section #eje of this ,act1 and section #cea7;a7 of the ,public ,health ,service ,act so long as the conditions specified in paragraphs 7#b71 7#c71 and 7#d7 are met with respect to the provision of such investigational drugs4 7#b7 ,compliance with certain regulations ,the conditions specified in this paragraph1 with respect to an eligible investigational drug referred to in paragraph 7#a71 are that-- 7,a7 the eligible investigational drug is labeled in accordance with section #cab4f of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 and 7,b7 the provision of such eligible investigational drug occurs in compliance with the applicable requirements set forth in sections #cab4g and #cab4h7;d77#a7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 that apply to investigational drugs1 subject to paragraph 7#e74 7#c7 ,notification ,the condition specified in this paragraph1 with respect to an eligible investigational drug referred to in paragraph 7#a71 is that the sponsor of such eligible investigational drug notifies the ,secretary of the provision of such eligible investigational drug for use by an eligible patient pursuant to this section4 ,such notification shall be submitted within #g business days of the provision of such eligible investigational drug as correspondence to the investigational new drug application described in subsection 7a77#b74 7#d7 ,adverse event reporting ,the condition specified in this paragraph1 with respect to an eligible investigational drug referred to in paragraph 7#a71 is that the sponsor or manufacturer of such eligible investigational drug has required1 as a condition of providing the drug to a physician for use by an eligible patient pursuant to this section1 that such physician will immediately report to such sponsor or manufacturer any serious adverse events1 as such term is defined in section #cab4cb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 associated with the use of the eligible investigational drug by the eligible patient4 7#e7 ,application ,for purposes of this section1 the requirements set forth in sections #cab4g and #cab4h7;d77#a7 of title #ba of the ,code of ,federal ,regulations 7or any successor regulations7 are deemed to apply to any person who manufactures1 distributes1 prescribes1 dispenses1 introduces or delivers for introduction into interstate commerce1 or provides to an eligible patient an eligible investigational drug pursuant to this section4 7c7 ,use of clinical outcomes 7#a7 ,in general ,notwithstanding any other provision of this ,act1 the ,public ,health ,service ,act1 or any other provision of ,federal law1 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 #eje of this ,act or section #cea of the ,public ,health ,service ,act unless-- 7,a7 the ,secretary makes a determination1 in accordance with paragraph 7#b71 that use of such clinical outcome is critical to determining the safety of the eligible investigational drug2 or 7,b7 the sponsor requests use of such outcomes4 7#b7 ,limitation ,if the ,secretary makes a determination under paragraph 7#a77;,a71 the ,secretary shall provide written notice of such determination to the sponsor1 including a public health justification for such determination1 and such notice shall be made part of the administrative record4 ,such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug4 7d7 ,reporting ,the manufacturer or sponsor of an eligible investigational drug that provides an eligible investigational drug pursuant to this section shall post on the same publicly available internet website used by the manufacturer for purposes of section #efa;,a7b7 an annual summary of any provision by the manufacturer or sponsor of an eligible investigational drug under this section4 ,the summary shall include the number of requests received1 the number of requests granted1 the number of patients treated1 the therapeutic area of the drug made available1 and any known or suspected serious adverse events1 as such term is defined in section #cab4cb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 associated with the use of the eligible investigational drug4 7e7 ,rule of construction ,nothing in this section shall be construed as limiting the authority of the ,secretary to require manufacturers or sponsors of investigational drugs to review and report information relevant to the safety of such investigational drug obtained or otherwise received by the sponsor pursuant to part #cab of title #ba1 ,code of ,federal ,regulations 7or successor regulations74 4 7b7 ,no liability ,section #efa;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 is amended by adding at the end the following3 7f7 ,liability 7#a7 ,alleged acts or omissions 7,a7 ,manufacturer or sponsor ,no manufacturer or sponsor 7or their agent or representative7 of an investigational drug shall be liable for any alleged act or omission related to the provision of such drug to a single patient or small group of patients for treatment use in accordance with subsection 7b7 or 7c7 of section #efa or the provision of an eligible investigational drug to an eligible patient in accordance with this section1 including1 with respect to the provision of an investigational drug under section #efa or an eligible investigational drug under this section1 the reporting of safety information1 from clinical trials or any other source1 as required by section #cab4cb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,physician1 clinical investigator1 or hospital 7i7 ,no licensed physician1 clinical investigator1 or hospital shall be liable for any alleged act or omission related to the provision of an investigational drug to a single patient or small group of patients for treatment use in accordance with subsection 7b7 or 7c7 of section #efa1 as described in clause 7ii71 or the provision of an eligible investigational drug to an eligible patient in accordance with this section1 unless such act or omission constitutes on the part of such physician1 clinical investigator1 or hospital with respect to such investigational drug or eligible investigational drug-- 7,i7 willful or criminal misconduct2 7,,ii7 reckless misconduct2 7,,iii7 gross negligence relative to the applicable standard of care and practice with respect to the administration or dispensing of such investigational drug2 or 7,,iv7 an intentional tort under applicable ,state law4 7ii7 ,the requirements described in this clause are the requirements under subsection 7b7 or 7c7 of section #efa1 including-- 7,i7 the reporting of safety information1 from clinical trials or any other source1 as required by section #cab4cb of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7,,ii7 ensuring that the informed consent requirements of part #ej of title #ba1 ,code of the ,federal ,regulations 7or any successor regulations7 are met2 and 7,,iii7 ensuring that review by an institutional review board is obtained in a manner consistent with the requirements of part #ef of title #ba1 ,code of the ,federal ,regulations 7or any successor regulations74 7#b7 ,determination not to provide drug ,no manufacturer1 sponsor1 licensed physician1 clinical investigator1 or hospital shall be liable for determining not to provide access to an investigational drug under this section or for discontinuing any such access that it initially determined to provide4 7#c7 ,limitation 7,a7 ,in general ,except as set forth in paragraphs 7#a7 and 7#b71 nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action against a manufacturer or sponsor 7or their agent or representative71 physician1 clinical investigator1 hospital1 prescriber1 dispenser1 or other entity under any ,state or ,federal product liability1 tort1 consumer protection1 or warranty law4 7,b7 ,federal ,government ,nothing in this section shall be construed to modify or otherwise affect the authority of the ,federal ,government to bring suit under any ,federal law4 4 ,passed the ,house of ,representatives ,march #ba1 #bjah4,karen ,l4 ,haas1,clerk4 ,april #i1 #bjah,read the second time and placed on the calendar