WASHINGTON (dpa-AFX) - President Donald Trump has signed an Executive Order that will accelerate access to treatments for patients with serious mental illness, reaffirming his commitment to advancing solutions that provide hope to Americans with devastating, complex, and treatment-resistant conditions.
The Order directs the Food and Drug Administration Commissioner to provide Commissioner's National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designations for treating serious mental illnesses, and that meet the criteria of the National Priority Voucher Program. This will ensure that red tape does not delay the FDA's gold standard review of any potential therapy.
The Order further directs the FDA and the Drug Enforcement Agency to establish a pathway for eligible patients to access investigational psychedelic drugs, including ibogaine compounds, that are under FDA review and that have met basic safety requirements under the Right to Try Act.
The Order requires the Secretary of Health and Human Services to allocate $50 million through the Advanced Research Projects for Health (ARPA-H) program to match investments made by state governments to advance research into psychedelic programs for populations with serious mental illness.
The Order requires HHS and the FDA to collaborate with the Department of Veterans Affairs and the private sector to increase clinical trial participation and evidence generation surrounding experimental psychedelic therapies.
It also directs the Attorney General to initiate reviews of relevant products upon successful completion of their Phase 3 clinical trials so that they can be rescheduled as soon as possible upon FDA approval, where appropriate.
U.S. Governments has long struggled to address the burden of suicide and serious mental illness rates in the country, with veterans often suffering in greater measure.
Today, more than 14 million American adults have a serious mental illness- a diagnosable mental, behavioral, or emotional disorder that substantially interferes with a person's life and ability to function.
8 million of these are on prescription medication for their conditions, the White House said in a fact sheet.
Suicide rates during the first Trump Administration decreased for the first time since 2000, but the White House alleged that the Covid pandemic and the Biden Administration's prolonged shutdown stunted this progress, and suicide rates rebounded upwards again to their peak rate in 2022.
For over 20 years, there have been more than 6,000 veteran suicides per year.
The suicide rate among veterans is more than twice as high as that of the non-veteran adult population.
World-leading medical research institutions, including Stanford University, Harvard University, and Johns Hopkins University, are studying therapies involving psychedelics, and experts believe the results could be promising.
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