Senators Press FDA To Approve MDMA As PTSD Treatment, Stressing US Vets' Suicide Rates As Aug 11 Decision Looms

In another bipartisan effort, U.S. Senators Michael Bennet (D-Colo.), Thom Tillis (R-N.C.), Kyrsten Sinema (I-Ariz.), and Rand Paul (R-Ky.), along with 15 colleagues called on the U.S. Food and Drug Administration (FDA) to base its upcoming decision on MDMA-Assisted Therapy for Post-Traumatic Stress Disorder (PTSD) on solid scientific evidence. This therapy could be pivotal in addressing the mental health crisis among U.S. veterans.

By August 11, the FDA is expected to decide whether MDMA – the chemical found in ecstasy or molly – can be prescribed as a treatment for PTSD.

In a letter addressed to FDA commissioner Robert Califf, the senators emphasized the dire need for new PTSD treatments, pointing out that the last FDA-approved medication for PTSD came nearly 25 years ago. "Existing treatments and medicines for PTSD…have not decreased the frequency of suicide within the veteran community. As a nation, we cannot allow our veterans to continue to suffer in silence," they wrote.

Urgent Need For New Treatments

Every year, approximately 6,000 U.S. veterans die by suicide. Untreated mental health issues, including PTSD, significantly heighten the risk of homelessness, addiction and depression among veterans. The potential for MDMA therapy to revolutionize PTSD treatment is immense, but further research is crucial to confirm its safety and efficacy.

"The potential for groundbreaking advancements in PTSD treatment is within reach," the senators continued. "We owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence."

Call For Rigorous Review

The letter was also signed by Senators Cory Booker (D-N.J.), Catherine Cortez Masto (D-Nev.), Tammy Duckworth (D-Ill.), John Fetterman (D-Pa.), Martin Heinrich (D-N.M.), John Hickenlooper (D-Colo.), Tim Kaine (D-Va.), Ben Ray Luján (D-N.M.), Ed Markey (D-Mass.), Markwayne Mullin (R-Okla.), Gary Peters (D-Mich.), Peter Welch (D-Vt.), and Ron Wyden (D-Ore.).

The senators urged the FDA commissioner to uphold the agency’s rigorous standards and highlighted the critical role of the FDA in ensuring that new treatments are safe and effective. "The FDA is internationally recognized as the gold standard for drug safety and efficacy review, and we urge the Agency to continue upholding this rigorous standard," they stated.

Hope For Veterans

The legislators stressed that MDMA therapy could be a game-changer for those suffering from PTSD if proven effective and safe. They noted the FDA's 2017 designation of MDMA as a breakthrough therapy, which underscores its potential. The letter concluded with a call for a comprehensive, evidence-based review process that could lead to new, effective treatments for veterans and others affected by PTSD.

"We appreciate your consideration on this critical issue," the senators wrote, stressing the importance of providing veterans with access to potentially life-saving therapies.