U.S. Senators Rand Paul (R-KY), Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ), alongside 15 of their Senate colleagues, urged U.S. Food and Drug Administration (FDA) Commissioner Robert Califf to remain firmly anchored in scientific evidence and data as the FDA considers approval of MDMA-Assisted Therapy (MDMA-AT) to treat Post-Traumatic Stress Disorder (PTSD). MDMA-AT could help address the mental and behavioral crisis, especially among American veterans.
“Existing treatments and medicines for PTSD, the last of which FDA approved nearly 25 years ago, 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 and must identify treatments proven to drastically decrease the adverse effects of PTSD,” wrote Paul, Bennet, Tillis, and Sinema.
Every year, 6,000 U.S. veterans die by suicide – and untreated mental health challenges, including PTSD, put veterans at heightened risk of homelessness, addiction, and depression. Breakthrough therapies and scientific advancements such as MDMA-AT offer new hope for those suffering from PTSD, but more research is needed to ensure these treatments are safe and effective.
“The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence,” continue the senators. “The rigorous, evidence-based review process by the FDA will be critical in making informed decisions that could offer a new lease on life for many individuals, including veterans, affected by this condition.”
In addition to Paul, Bennet, Tillis, and Sinema, U.S. Senators Cory Booker (D-NJ), Catherine Cortez Masto (D-NV), Tammy Duckworth (D-IL), John Fetterman (D-PA), Martin Heinrich (D-NM), John Hickenlooper (D-CO), Tim Kaine (D-VA), Ben Ray Luján (D-NM), Ed Markey (D-MA), Jeffrey Merkley (D-OR), Markwayne Mullin (R-OK), Gary Peters (D-MI), Peter Welch (D-VT), Sheldon Whitehouse (D-RI), and Ron Wyden (D-OR) also signed onto this letter.
The text of the letter is available HERE and below.
Dear Commissioner, Califf:
We write to you today regarding the U.S. Food and Drug Administration’s (FDA) consideration of MDMA-Assisted Therapy (MDMA-AT) as a Post-Traumatic Stress Disorder (PTSD) treatment. Existing treatments and medicines for PTSD, the last of which FDA approved nearly 25 years ago, 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 and must identify treatments proven to drastically decrease the adverse effects of PTSD.
Untreated PTSD can lead to negative consequences, such as homelessness, addiction, depression, and suicide. Our country has a severe veteran suicide and PTSD crisis where 6,000 veterans die by suicide each year, with over 150,000 suicides since 9/11. Advancements in scientific research offer new hope for those suffering from PTSD; MDMA-AT is one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle, which the FDA recognized in 2017 when they designated MDMA-AT as a Breakthrough Therapy.
Seven years have passed, and with several innovative therapies currently under review and more on the horizon, the FDA should remain firmly anchored in scientific evidence and data when evaluating new treatments. The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence. 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 of safety, quality, and effectiveness, especially for therapies targeting conditions like PTSD, which is alarmingly prevalent among our nation’s veterans.
Given the substantial burden of PTSD and the current treatment limitations, the possibility of new, more effective therapies is particularly meaningful. One such promising therapy under consideration is MDMA-assisted therapy (MDMA-AT). If comprehensive evidence demonstrates that MDMA-AT is both effective and safe when administered in appropriate settings, it is our responsibility to ensure that this treatment option is made available to those who could benefit from it. The rigorous, evidence-based review process by the FDA will be critical in making informed decisions that could offer a new lease on life for many individuals, including veterans, affected by this condition.
We appreciate your consideration on this critical issue.
