,i #aaeth ,,congress #ast ,session ,h4 ,r4 #bcfh ,,in ,,the ,,house ,,of ,,representatives ,may #d1 #bjag,mr4 ,fitzpatrick 7for himself1 ,ms4 ,sinema1 and ,mr4 ,biggs7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to authorize the use of experimental drugs1 biological products1 and devices by patients diagnosed with a terminal illness in accordance with ,state law1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,right to ,try ,act4 #b4 ,use of unapproved medical products by patients diagnosed with a terminal illness 7a7 ,in general ,notwithstanding the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 and any other provision of ,federal law1 the ,federal ,government shall not take any action to prohibit or restrict-- 7#a7 the production1 manufacture1 distribution1 prescribing1 or dispensing of an experimental drug1 biological product1 or device that-- 7,a7 is intended to treat a patient who has been diagnosed with a terminal illness2 and 7,b7 is authorized by1 and in accordance with1 ,state law2 and 7#b7 the possession or use of an experimental drug1 biological product1 or device-- 7,a7 that is described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a72 and 7,b7 for which the patient has received a certification from the patient's treating physician in accordance with subsection 7b74 7b7 ,physician certification ,a certification by the patient's treating physician referred to in subsection 7a77#b77;,b7 must include each of the following3 7#a7 ,a certification that the physician-- 7,a7 is in good standing with the physician's certifying organization or board2 and 7,b7 has personally examined the patient4 7#b7 ,a certification that there is no reason to conclude the experimental drug1 biological product1 or device poses an unreasonable and significant risk of danger to the patient4 7#c7 ,a certification that the patient has been diagnosed with a terminal disease or condition and does not have any treatment options that-- 7,a7 are comparable to treatment using the experimental drug1 biological product1 or device or otherwise satisfactory2 and 7,b7 are approved1 licensed1 or cleared for commercial distribution under section #eje1 #eaj7k71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 and are available to diagnose1 monitor1 or treat the patient's disease or condition4 7#d7 ,a certification that the probable risk to the patient from the experimental drug1 biological product1 or device is not greater than the probable risk from the patient's disease or condition4 7#e7 ,a certification that the physician has provided the patient with a written statement and oral explanation of the medical treatment to be provided using the experimental drug1 biological product1 or device4 7#f7 ,an acknowledgement signed by the patient 7or the patient's legal representative7 that the physician has provided the written statement and oral explanation required by paragraph 7#e71 and has disclosed the following3 7,a7 ,that the medical treatment using the experimental drug1 biological product1 or device is experimental or nonconventional4 7,b7 ,that the experimental drug1 biological product1 or device has not been approved1 licensed1 or cleared for commercial distribution under section #eje1 #eaj7k71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for any indication4 7,c7 ,the material risks generally recognized by a reasonably prudent physician of the medical treatment's side effects4 7,d7 ,an explanation of the medical treatment1 including the expected frequency and duration of the treatment4 7c7 ,no liability or use of outcomes 7#a7 ,no liability ,notwithstanding any other provision of law1 no liability shall lie against a producer1 manufacturer1 distributor1 prescriber1 dispenser1 possessor1 or user of an experimental drug1 biological product1 or device for the production1 manufacture1 distribution1 prescribing1 dispensing1 possession1 or use of an experimental drug1 biological product1 or device that is in compliance1 with subsection 7a74 7#b7 ,no use of outcomes ,notwithstanding any other provision of law1 the outcome of any production1 manufacture1 distribution1 prescribing1 dispensing1 possession1 or use of an experimental drug1 biological product1 or device that was done in compliance with subsection 7a7 shall not be used by a ,federal agency reviewing the experimental drug1 biological product1 or device to delay or otherwise adversely impact review or approval of such experimental drug1 biological product1 or device4 7d7 ,rules of construction ,nothing in this ,act shall be construed to-- 7#a7 require a manufacturer or other person to make available any experimental drug1 biological product1 or device2 or 7#b7 prohibit a manufacturer or other person from receiving compensation or recovering costs for the production1 manufacture1 distribution1 or sale of an experiment drug1 biological product1 or device4 7e7 ,definitions ,in this section3 7#a7 ,biological product ,the term biological product has the meaning given to such term in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,device2 drug ,the terms device and drug have the meanings given to such terms in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#c7 ,experimental drug1 biological product1 or device ,the term experimental drug1 biological product1 or device means a drug1 biological product1 or device that-- 7,a7 has successfully completed a phase #a clinical investigation2 7,b7 remains under investigation in a clinical trial approved by the ,food and ,drug ,administration2 and 7,c7 is not approved1 licensed1 or cleared for commercial distribution under section #eje1 #eaj7k71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj7;e77 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,phase #a clinical investigation ,the term phase #a clinical investigation means a phase #a clinical investigation1 as described in section #cab4ba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7#e7 ,terminal illness ,the term terminal illness has the meaning given to such term in the ,state law specified in subsection 7a77#a77;,b74