Trump signs order to hasten psychedelic medicine access

President Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelic medicines for serious mental illness to patients.

Among the measures the regulatory authority has been asked to introduce is the extension of the Commissioner’s National Priority Voucher (CNPV) – which can cut regulatory review times from months down to a matter of weeks – for "appropriate psychedelic drugs that have received breakthrough therapy designations."

It also orders $50 million in federal funding to be allocated for promising research projects, administered by the Advanced Research Projects for Health (ARPA-H) programme, and initiatives to increase participation in clinical trials.

The order was announced at a White House event on Saturday attended by podcaster Joe Rogan, who has been an advocate of psychedelic treatments for psychiatric disorders and, according to Trump, brought the potential of one drug – ibogaine for post-traumatic stress disorder (PTSD) – to the President's attention.

Ibogaine, a Schedule I controlled substance that is already used for PTSD in some countries outside the US, was highlighted in a fact sheet published by the White House that called for the FDA and Drug Enforcement Agency (DEA) to establish a pathway for eligible patients to access investigational psychedelic drugs under the Right to Try Act of 2017.

Psychedelics developer Gilgamesh Pharma is developing a derivative of ibogaine for PTSD in the US, GM-3009, which is designed to reduce cardiac side effects and is in early-stage clinical testing. And last year, the state of Texas launched a research consortium to accelerate ibogaine clinical trials and drug development.

"Today's order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life," said Trump at the event, which was also attended by retired US Navy Seal Marcus Luttrell, who was awarded the Navy Cross and Purple Heart for his actions in June 2005 against the Taliban in Afghanistan.

"You're going to save a lot of lives through it," said Luttrell, who has used ibogaine and 5-MeO-DMT to treat physical pain, trauma, and dependency on prescription opioid analgesics, which resulted from injuries sustained during his military service. "It absolutely changed my life for the better."

HHS Secretary Robert F Kennedy Jr, who was also present at the White House event, has a history of supporting psychedelics, and before joining the Trump administration had accused the FDA of "suppressing" the treatments.