Expanding Veterans’ Access to Emerging Treatments Act

(1) Many conditions, such as chronic pain, post-traumatic stress disorder, and substance use disorders, continue to challenge the veteran community amid a lack of new innovative treatments and emerging therapies.

(2) These and other conditions represent an urgent unmet medical need among veterans.

(3) The Department of Veterans Affairs should continue to advance research and facilitate timely access to innovative treatments and emerging therapies, including psychedelic- and entactogenic-assisted therapies, for veterans with such unmet treatment needs.

Not later than 90 days after the date of enactment of this Act, the Secretary of Veterans Affairs shall develop an investigational research program for the treatment of veterans diagnosed with a covered condition using innovative treatments and emerging therapies, consistent with applicable Federal law, including laws governing investigational medical products and controlled substances. Not later than 60 days after the date of the enactment of this Act, the Secretary shall designate a lead administrator to carry out the research and treatment program under this section.

The Department of Veterans Affairs may—

(1) conduct one or more clinical trials for the treatment of a covered condition that include veterans as participants in the clinical trial using innovative treatments and emerging therapies, which may be selected following a review of their efficacy, safety, and ease of administration; and

(2) develop a compassionate or extended access protocol that facilitates consideration of, and as appropriate access to, innovative treatments and emerging therapies.

The Secretary shall establish a process under which a veteran diagnosed with a covered condition may—

(1) participate in a clinical trial conducted under this section; or

(2) be considered for access to an innovative treatment or emerging therapy under a compassionate or extended access protocol, as clinically appropriate.

In addition to carrying out the activities under this section, the Secretary may, using amounts otherwise authorized to be appropriated and otherwise available to the Department of Veterans Affairs, support one or more clinical research trials using innovative treatments and emerging therapies described in subsection (g).

Not later than one year after the date of the enactment of this Act, the Secretary shall submit to the Committees on Veterans’ Affairs of the House of Representatives and the Senate a report, including the following:

(1) Identification of clinics designated to host activities under such a protocol under this section and the number of veterans expected to participate in a clinical trial conducted in subsection (b);

(2) Information on the findings and outcomes of such clinical trials, including preliminary outcomes; and

(3) A review of all innovative treatments and emerging therapies utilized for the treatment of covered conditions, including safety and efficacy studies, cost, regulatory, and logistical considerations associated with each.

Not later than two years after the date of enactment of this Act, the investigational program shall be reviewed by the Secretary of Veterans Affairs, who may then choose to extend or terminate the program at their discretion.

In this section:

(1) The term innovative treatment means any of the following:

(A) 3,4-Methylenedioxy-methamphetamine;

(B) 5-Methoxy-N,N-dimethyltryptamine;

(C) 5-Methoxy-2-aminoindane;

(D) Ibogaine;

(E) Ketamine;

(F) Psilocybin; and

(G) Such other treatments as may be designated by the Secretary.

(2) The term emerging therapies means any of the following:

(A) Investigational pharmaceutical candidates that meet the Government’s Definition of Recovery;

(B) Investigational medical devices, such as deep brain neurostimulation or hyperbaric oxygen therapy; and

(C) Such other therapeutic interventions as may be designated by the Secretary.

(3) The term covered condition means any of the following:

(A) Anxiety;

(B) Chronic pain;

(C) Depression;

(D) Post-traumatic stress disorder;

(E) Substance use disorders, including but not limited to alcohol use and cocaine use disorders;

(F) Traumatic brain injury; and

(G) Such other conditions as may be designated by the Secretary.

Nothing in this section shall be construed to require or direct the Secretary to act in a manner inconsistent with applicable Federal law, including laws governing investigational medical products and controlled substances.