,i #aaith ,,congress #b;d ,session ,h4 ,r4 #iedg ,,in ,,the ,,house ,,of ,,representatives ,june #cj1 #bjbf,mr4 ,hamadeh of ,arizona 7for himself1 ,mr4 ,bacon1 ,mr4 ,crenshaw1 and ,mr4 ,moulton7 introduced the following bill2 which was referred to the ,committee on ,armed ,services ,a ,,bill ,to direct the ,secretary of ,defense to submit to ,congress a report on emerging investigational treatment options for treatment-resistant post-traumatic stress disorder in veterans1 members of the ,armed ,forces1 and members transitioning to civilian life1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,veterans and ,servicemembers ,,ptsd ,emerging ,treatment ,review ,act of #bjbf4 #b4 ,report on emerging treatment options for treatment-resistant post-traumatic stress disorder 7a7 ,findings ,congress finds the following3 7#a7 ,post-traumatic stress disorder often originates during military service and can have persistent effects on force health1 medical readiness1 retention1 family stability1 and successful transition from military service to civilian life4 7#b7 ,members of the reserve components and ,national ,guard may also serve in civilian first responder roles1 resulting in cumulative trauma exposure that may compound service-connected mental health burdens4 7#c7 ,existing therapies for post-traumatic stress disorder are not effective for all patients1 and treatment-resistant cases may be associated with elevated risks of chronic impairment1 substance misuse1 suicidality1 and reduced readiness4 7#d7 ,rigorous1 ethical clinical research conducted in accordance with ,federal law and force health protection standards is necessary to evaluate emerging treatments for service-connected mental health conditions where existing therapies have proven insufficient4 7#e7 ,the ,state of ,arizona has enabled regulatory and administrative support for clinical trials authorized by the ,food and ,drug ,administration evaluating naturally derived1 whole-mushroom psilocybin administered within a structured group-therapy setting for the treatment of post-traumatic stress disorder in veterans and first responders4 7#f7 ,private-sector innovators and public-private partnerships play a central role in developing1 supplying1 and evaluating federally lawful investigational products used in such clinical trials4 7#g7 ,clinical data from the randomized controlled ,phase ,i ,passage ,trial and the ,phase ,,ii ,fortitude ,trial sponsored by the ,state of ,arizona may provide relevant information regarding safety1 dosing1 adverse events1 feasibility1 and operational considerations for future research involving veterans1 servicemembers1 and transitioning servicemembers4 7#h7 ,careful review by the ,department of ,defense of safety1 dosing1 feasibility1 and continuity-of-care considerations associated with emerging investigational therapies is appropriate to inform future force health protection policy1 medical readiness planning1 suicide prevention efforts1 and military-to-civilian transition support4 7#i7 ,any potential expanded access pathway or pilot activity involving an investigational ,schedule ,i substance must be evaluated in accordance with applicable ,federal law and regulations1 including requirements administered by the ,food and ,drug ,administration and the ,drug ,enforcement ,administration1 and applicable regulatory agencies should act in a timely manner to issue or update regulations1 guidance1 authorizations1 and procedures necessary to enable lawful research and access for eligible patients1 consistent with the ,federal ,right to ,try ,act1 expanded access authorities1 and the ,april #ah1 #bjbf1 ,executive ,order titled ,accelerating ,medical ,treatments for ,serious ,mental ,illness1 while maintaining appropriate safety1 security1 and diversion-control safeguards4 7#aj7 ,congress has a responsibility to ensure that the ,department of ,defense assesses whether emerging clinical research may offer future benefit for active-duty servicemembers1 reserve component members1 veterans1 and transitioning servicemembers with treatment-resistant post-traumatic stress disorder4 7b7 ,report ,not later than #ahj days after the date of the enactment of this ,act1 the ,assistant ,secretary of ,defense for ,health ,affairs shall submit to the congressional defense committees a report on the operational relevance1 safety1 dosing1 and feasibility of data from the covered clinical trial as such data would apply to members of the ,armed ,forces1 including such members transitioning to civilian life4 7c7 ,elements ,the report under subsection 7b7 shall include the following3 7#a7 ,a summary of the safety1 dosing1 and adverse event data from the covered clinical trial that has been reviewed by any relevant department or agency of the ,federal ,government1 or that is otherwise available to the ,department of ,defense1 and an analysis by the ,department of ,defense of the applicability of such data to members of the ,armed ,forces4 7#b7 ,an assessment of the implications of such data for force health protection1 medical readiness1 and suicide prevention strategies1 including identification of any gaps in existing treatment options for members of the ,armed ,forces with treatment-resistant post-traumatic stress disorder4 7#c7 ,a description of the legal and regulatory requirements for any potential expanded access pathway involving an investigational ,schedule ,i substance1 including coordination requirements with the ,food and ,drug ,administration and the ,drug ,enforcement ,administration4 7#d7 ,an assessment of the applicability of the ,federal right to try the pathway under section #efa;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 and under ,executive ,order ,no4 #addja 7#ia ,fed4 ,reg4 #bagji2 relating to accelerating medical treatments for serious mental illness7 the for treatment-resistant post-traumatic stress disorder and associated comorbidities1 including elevated suicide risk during post-deployment and transition periods4 7#e7 ,an assessment of considerations necessary to ensure continuity of care for members of the ,armed ,forces transitioning from receiving health care at military medical treatment facilities to receiving health care furnished by the ,veterans ,health ,administration1 including-- 7,a7 eligibility criteria2 7,b7 clinical treatment oversight2 7,c7 informed consent procedures2 7,d7 safety monitoring2 and 7,e7 adverse event reporting4 7#f7 ,an assessment of the financial resources1 workforce1 and infrastructure requirements1 and a proposed timeline1 for any potential pilot activities or expanded clinical research beginning in fiscal year #bjbg1 and for any broader implementation occurring thereafter1 as appropriate4 7d7 ,coordination and consultation ,the ,assistant ,secretary of ,defense for ,health ,affairs shall develop the report under subsection 7b7 in coordination with the ,director of the ,defense ,health ,agency and in consultation with the ,secretary of ,veterans ,affairs1 the ,secretary of ,health and ,human ,services1 the ,commissioner of ,food and ,drugs1 and the heads of other departments and agencies of the ,federal ,government the ,assistant ,secretary determines appropriate4 7e7 ,form ,the report required under subsection 7b7 shall be submitted in unclassified form1 but may include a classified annex if necessary4 7f7 ,definitions ,in this section3 7#a7 ,the term congressional defense committees has the meaning given that term in section #aja7;a77#af7 of title #aj1 ,united ,states ,code4 7#b7 ,the term covered clinical trial means the clinical trial conducted in #bjbf titled ,an ,open-,label1 ,phase #a ,study of the ,safety ,pharmacokinetic ,profile1 and ,preliminary ,efficacy1 of ,organic ,whole ,psilocybin-,containing ,mushrooms in ,patients ,suffering ,from ,,ptsd4