Politics
80 Bipartisan Lawmakers Push FDA To Seriously Consider Approving MDMA-Assisted Therapy
A bipartisan and bicameral coalition of congressional lawmakers is expressing urgency to the federal government as it looks into the possibility of authorizing MDMA-assisted therapy, particularly as it concerns veterans with severe mental health conditions.
A total of 80 members of Congress—including 19 senators and 61 representatives from the House—sent separate letters to the Biden administration and the head of the Food and Drug Administration (FDA) this past week, urging serious consideration of approving the psychedelic as a treatment option for post-traumatic stress disorder (PTSD).
MDMA is “one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle,” the Senate letter says, noting that FDA has already designated it as a breakthrough therapy.
This comes about a month after an FDA advisory panel rejected an application to authorize MDMA-assisted therapy. Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval and also launched an art installation memorializing military veterans who die by suicide.
“FDA should remain firmly anchored in scientific evidence and data when evaluating new treatments,” the new letter, led by Sens. Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ) and Rand Paul (R-KY), says. “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.”
Each year, 6,000 U.S. veterans die by suicide. We must do everything we can to ensure they don’t keep suffering in silence.
I joined a bipartisan effort to urge @US_FDA to support breakthrough MDMA-Assisted Therapy for PTSD within our veteran communities.https://t.co/JDexiO0hi4
— Michael Bennet (@SenatorBennet) August 5, 2024
“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,” the senators wrote.
“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.”
The House letter, led by Reps. Jack Bergman (D-RI), Lou Correa (D-CA), Morgan Luttrell (R-TX) and Jimmy Panetta (D-CA), similarly expressed signatories’ “sense of urgency” to address the suicide epidemic among veterans, as well as “the grave need for new and better treatment options like MDMA-assisted therapy.”
“Promising new treatments like MDMA-assisted therapy (MDMA-AT) have the clinically proven potential to bring Veterans who have long suffered with PTSD a treatment that works,” the lawmakers wrote. “MDMA-AT has shown enormous promise in privately funded research for decades and was officially designated a ‘Breakthrough Therapy’ by the FDA in 2017.”
“We understand that the FDA has a statutory obligation to carefully weigh both the risks and benefits of any new drug application. This duty is undoubtedly more complicated when dealing with a novel treatment like MDMA-assisted therapy, which calls on the FDA to consider not only the risks and benefits of a novel drug, but also the unique combination of a pharmaceutical when combined with psychotherapy interventions.”
The letter acknowledges that, as the MDMA-assisted therapy drug application has gone through the review process, “certain groups and individuals have voiced criticism of the application.”
It’s time to follow the data, not politics when it comes to saving our Veterans’ lives. MDMA-AT has a proven efficacy for treating PTSD that we can’t deny – so we shouldn’t deny Veterans access to its therapies.https://t.co/TxZucncalh
— Rep. Jack Bergman (@RepJackBergman) August 5, 2024
“It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA,” the lamwkaers said.
“While all Americans are free to voice their views on this and other topics of public interest, scientific evidence should not be ignored in favor of those who have been on a mission to discredit this promising treatment at all costs—especially when that would come at the cost of our servicemembers and Veterans.
Thousands of Veterans suffering from PTSD continue to take their lives each year. Current treatments clearly are not working well enough, and our Veterans can no longer wait. If the data and evidence show that MDMA-AT is safe and effective at relieving the suffering that many Veterans face, then we owe it to them and the millions of others who are living with PTSD to make this treatment option available to them. We appreciate your consideration of our views on this matter and look forward to the FDA’s decision on this application.”
In a statement to Marijuana Moment, Luttrell said that, as a combat veteran who has personal experience with psychedelics therapy, “I fully support the use of emerging therapies to treat the PTSD and suicide epidemic among our veterans and service members.”
“We owe it to those who have sacrificed so much for our country to explore new and effective treatment options, such as MDMA-assisted therapy,” he said. “This innovative approach has shown promising results and would be a critical tool in our fight to treat combat-related injuries. It’s time to take bold steps to ensure that no veteran is left behind.”
Among the other signatories on the Senate letter are: Sens. 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), Markwayne Mullin (R-OK), Gary Peters (D-MI), Peter Welch (D-VT) and Ron Wyden (D-OR).
On the House side, signatories include: Reps. Doug Lamborn (R-CO), Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA), Joe Neguse (D-CO), Mark Pocan (D-WI), David Trone (D-MD), Tom McClintock (R-CA), Brian Mast (R-FL), Pete Sessions (R-TX), Eric Swalwell (D-CA), Robert Garcia (D-CA), Nancy Mace (R-SC), Alexandria Ocasio-Cortez (D-NY) and Doug LaMalfa (R-CA).
Luttrell, who helped spearhead the House letter, has also discussed his own personal experience using psychedelic medicines to treat mental health conditions following his service-related trauma.
Amid growing calls among veterans advocacy groups and lawmakers, especially Republicans, to speed research and access to psychedelic-assisted therapy, House lawmakers in June approved amendments to a large-scale spending bill that would authorize U.S. Department of Veterans Affairs (VA) doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.
The psychedelics-focused provision would encourage VA to support research into the benefits of psychedelics in treating medical conditions commonly affecting military veterans.
Photo courtesy of Pretty Drugthings on Unsplash.
