Lawmakers Urge VA To Prepare Strategy For MDMA Therapy As FDA Weighs Approval

A group of Republican and Democrat congressional lawmakers has come together to ask the U.S. Department of Veterans Affairs (VA) to create a plan to implement therapy using MDMA for veterans should it be approved by the FDA. The bipartisan group of nine U.S. representatives sent a letter to VA Under Secretary Shereef Elnahal noting the FDA could approve treatments like MDMA therapy for PTSD as soon as this summer and they want VA to be prepared.

In February, the FDA agreed to examine MDMA-assisted therapy as a potential treatment for PTSD and granted Lykos Therapeutics—the company that has ushered MDMA therapy through three phases of clinical trials—priority review status. The FDA grants priority review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment of serious conditions (like PTSD) when compared to standard applications. If approved, the FDA ruling would be the first such federally backed psychedelic-assisted therapy available to patients in the United States.

The move by the group of nine lawmakers represents the second significant effort by Veterans Affairs this year to look at psychedelic therapies to help veterans with PTSD. Earlier this year, VA issued a request for “proposals from its network of VA researchers (in collaboration with academic institutions) to study the use of certain psychedelic compounds in treating PTSD”—namely MDMA and psilocybin to combat PTSD. Veterans Affairs announced in a press release from Jan 5, 2024, that it is the first time since the 1960s that VA is funding research on such compounds.

The recent congressional effort asking VA to prepare for MDMA therapy was led by Reps. Morgan Luttrell (R-Texas) and Morgan McGarvey (D-Kentucky). Also involved were members of the House Veterans Affairs Committee, including Reps. Jack Bergman (R-Michigan), Julia Brownley (D-California), Nikki Budzinski (D-Illinois), Mariannette Miller-Meeks (R-Iowa), Sheila Cherfilus-McCormick (D-Florida), Chris Deluzio (D-Pennsylvannia), and Greg Landsman (D-Ohio).

Texas Congressman Luttrell emphasized the need for improved therapies for PTSD in an era of overprescribed, and often addictive, drugs like opioids.

“The effects of emerging therapies for our veterans have been groundbreaking, and I’m proud to be a leader on pushing forward this innovative tool into the proverbial toolbox, especially while moving away from opioids,” said Congressman Luttrell in a recent release. “As the FDA is finally playing ball to move towards approving these therapies, it’s critical we ensure the VA has an implementation plan and can effectively and efficiently treat veterans.”

The letter highlights concerns raised by the congressional group about the implications of FDA approval of MDMA-assisted therapies for the wider public without a plan in place for veterans. Says the release, they look to “ensure treatments are available to veterans through VA and that there are adequate training initiatives to ensure proper staffing levels once these therapies are approved.” As such, they are requesting that Veterans Affairs produce an implementation plan that would be deployable as soon as the novel treatment option is approved for clinical use.

Because psychedelic dosing sessions require in-person monitoring by clinicians trained in the specific needs of people in vulnerable psychological states, staffing issues will be one significant obstacle to overcome. Unlike the current use of ketamine to treat depression, which can be prescribed to patients for home use, MDMA-assisted therapy will only be available in clinical settings. This will create a considerable need for trained clinicians to oversee treatments.

“The potential lack of in-house capacity at the VA could threaten the mental health of our nations’ veterans and carries significant cost implications for VA,” say the authors.

The lawmakers are requesting that a response from VA Under Secretary Elnahal be provided no later than July 1, 2024, ahead of the FDA’s priority review deadline of MDMA therapy set for August 11, 2024.