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Wednesday, December 4, 2024

Senators urge FDA to rely on science for MDMA-assisted therapy approval

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U.S. Senator Rand Paul | U.S. Senator Rand Paul official website

U.S. Senator Rand Paul | U.S. Senator Rand Paul official website

U.S. Senators Rand Paul (R-KY), Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ), along with 15 other Senate colleagues, have urged U.S. Food and Drug Administration (FDA) Commissioner Robert Califf to prioritize scientific evidence in the consideration of MDMA-Assisted Therapy (MDMA-AT) for treating Post-Traumatic Stress Disorder (PTSD). This therapy could potentially address mental health crises, particularly 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.

Annually, 6,000 U.S. veterans die by suicide, with untreated mental health challenges like PTSD increasing risks of homelessness, addiction, and depression. While breakthrough therapies such as MDMA-AT offer new hope for those suffering from PTSD, further research is necessary to ensure their safety and efficacy.

"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," continued 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 emphasizes that untreated PTSD can lead to severe consequences such as homelessness, addiction, depression, and suicide. The senators highlighted that since 9/11 over 150,000 suicides have occurred among veterans due to untreated mental health issues. They stressed that advancements in scientific research offer new hope for those suffering from PTSD; MDMA-AT is one of the most promising options available.

Seven years after recognizing MDMA-AT as a Breakthrough Therapy in 2017 by the FDA due to its potential benefits for PTSD patients under proper administration settings if proven effective and safe through comprehensive evidence.

"We appreciate your consideration on this critical issue," concluded the letter addressed to Commissioner Califf.

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