Douglas Mike Day Psychedelic Therapy to Save Lives Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3684 To direct the Secretary of Defense to establish a grant program for using psychedelic substances to treat certain conditions, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 25, 2023 Mr. CRENSHAW (for himself, Mr. LUTTRELL, Mr. BERGMAN, Ms. MACE, Mr. GAETZ, Ms. OCASIO-CORTEZ, Mr. MOSKOWITZ, Mr. ZINKE, Ms. LEE of Florida, Mr. CORREA, and Mr. VAN ORDEN) introduced the following bill; which was referred to the Committee on Armed Services A BILL To direct the Secretary of Defense to establish a grant program for using psychedelic substances to treat certain conditions, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Douglas ‘Mike’ Day 4 Psychedelic Therapy to Save Lives Act of 2023’’. 5 VerDate Sep 11 2014 00:18 Jun 20, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3684.IH H3684 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3684 IH SEC. 2. GRANT PROGRAM OF THE DEPARTMENT OF DE- 1 FENSE TO STUDY TREATMENT OF CERTAIN 2 CONDITIONS USING CERTAIN PSYCHEDELIC 3 SUBSTANCES. 4 (a) ESTABLISHMENT.—Not later than 90 days after 5 the date of enactment of this Act, the Secretary of Defense 6 shall award grants to eligible entities to conduct research 7 on the treatment of members of the Armed Forces serving 8 on active duty with a covered condition using covered psy- 9 chedelic substances. Not later than 60 days after the date 10 of the enactment of this Act, the Secretary shall designate 11 a lead administrator to carry out the grant program under 12 this section. 13 (b) ELIGIBLE ENTITIES.—The Secretary may award 14 a grant under this section to any of the following: 15 (1) A department or agency of the Federal Gov- 16 ernment or a State government. 17 (2) An academic institution. 18 (3) A nonprofit entity. 19 (c) USE OF GRANT FUNDS.—A recipient of a grant 20 awarded under this section may use the grant to— 21 (1) conduct one or more phase two clinical 22 trials for the treatment of covered conditions that— 23 (A) include members of the Armed Forces 24 serving on active duty as participants in the 25 clinical trial; and 26 VerDate Sep 11 2014 00:18 Jun 20, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3684.IH H3684 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3684 IH (B) use individual or group therapy as- 1 sisted by covered psychedelic substances; or 2 (2) train practitioners to provide treatment to 3 members of the Armed Forces serving on active duty 4 for covered conditions using covered psychedelic sub- 5 stances. 6 (d) PARTICIPATION IN CLINICAL TRIALS.—The Sec- 7 retary shall authorize any member of the Armed Forces 8 diagnosed with a covered condition to participate in a clin- 9 ical trial that is conducted using a grant awarded under 10 this section or funds provided under subsection (e) and 11 is authorized pursuant to section 505 of the Federal Food, 12 Drug, and Cosmetic Act (21 U.S.C. 355), without regard 13 to— 14 (1) whether the clinical trial involves a sub- 15 stance included in the schedule under section 202 of 16 the Controlled Substances Act (21 U.S.C. 812); or 17 (2) section 912a of title 10, United States Code 18 (article 112a of the Uniform Code of Military Jus- 19 tice). 20 (e) ADDITIONAL AUTHORITY.—In addition to award- 21 ing grants under this section, the Secretary shall provide 22 funds for a clinical research trial using covered psychedelic 23 substances that is authorized pursuant to section 505 of 24 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 25 VerDate Sep 11 2014 00:18 Jun 20, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3684.IH H3684 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3684 IH 355) and includes members of the Armed Forces as par- 1 ticipants in the trial. 2 (f) REPORT REQUIRED.—Not later than 180 days 3 after the date of the enactment of this Act, and every 180 4 days thereafter, the Secretary shall submit to the Commit- 5 tees on Armed Services of the House of Representatives 6 and the Senate a report on grants awarded under this sec- 7 tion, including the following: 8 (1) Identification of clinics designated to host 9 activities under such a grant. 10 (2) A description of entities to whom the Sec- 11 retary has awarded such a grant. 12 (3) The number of members of the Armed 13 Forces who participated in a clinical trial described 14 in subsection (d). 15 (4) Information on the findings of such clinical 16 trials. 17 (g) AUTHORIZATION OF APPROPRIATIONS.—There is 18 authorized to be appropriated to the Secretary to carry 19 out this section $15,000,000 for each of fiscal years 2024 20 through 2028. 21 (h) DEFINITIONS.—In this section: 22 (1) The term ‘‘covered condition’’ means any of 23 the following: 24 (A) Post-traumatic stress. 25 VerDate Sep 11 2014 00:18 Jun 20, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3684.IH H3684 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3684 IH (B) Traumatic brain injury. 1 (C) Chronic traumatic encephalopathy 2 (2) The term ‘‘covered psychedelic substances’’ 3 means any of the following: 4 (A) 3,4-Methylenedioxy-methamphetamine 5 (commonly known as ‘‘MDMA’’). 6 (B) Psilocybin. 7 (C) Ibogaine. 8 (D) 5-Methoxy-N,N-dimethyltryptamine 9 (commonly known as ‘‘5-MeO-DMT’’). 10 (3) The term ‘‘State’’ has the meaning given 11 such term in section 901 of title 32, United States 12 Code. 13 Æ VerDate Sep 11 2014 00:18 Jun 20, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H3684.IH H3684 pbinns on DSKJLVW7X2PROD with $$_JOB