Lawmakers Press FDA to Expedite Psychedelic Therapies for Mental Health

More than two dozen lawmakers are calling on the U.S. Food and Drug Administration (FDA) to expedite its review of mental health therapies like psychedelics as part of multiple pieces of legislation already drafted.

Military.com has reported on different legislative efforts in the House and Senate that largely center on the same objective: providing more expansive treatment options to both civilians along with current and former military service members who experience elevated rates of PTSD, depression and suicide.

On April 18, President Donald Trump in a rather unprecedented move signed an executive order calling on the FDA to facilitate access to psychedelic drugs, including ibogaine compounds, psilocybin, ketamine, LSD and MDMA, for eligible patients suffering from major depressive disorder and substance abuse disorders. Trump said the order “will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life.”

On May 1, a letter signed by 32 House Republicans and Democrats was sent to FDA Commissioner Martin Makary urging the agency to advance its evaluation of rapid-acting novel therapeutics. Reps. Jack Bergman (R-MI) and Lou Correa (D-CA), co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, initiated the correspondence.

“We are encouraged by your public statements recognizing these treatments as ‘a top priority for this FDA and this administration,’” the letter reads. “We agree that the agency must conduct ‘an expeditious and rapid review’ of promising treatments, especially those that address urgent unmet needs in PTSD, traumatic brain injury, and other neuropsychiatric conditions.”

The letter continues: “At the same time, we understand and respect the agency’s role in ensuring that any new treatment meets rigorous standards of safety and efficacy. Recent regulatory actions, including the issuance and public release of the Complete Response Letter (CRL) for MDMA-assisted therapy, highlight the complexity of evaluating innovative treatment modalities and underscore the need for clear, consistent expectations for this emerging field.”

Answers Sought by Lawmakers

The letter calls for Makary to respond to four major questions.

Those questions are as follows:

• Special Protocol Assessment (SPA) – How the FDA intends to communicate and apply any remaining data concerns beyond clearly defined primary endpoints and control conditions when pivotal trials are conducted under an SPA.
• Methodological Standards and Interagency Coordination – Steps being taken to clarify methodological expectations for entactogen- and psychedelicassisted clinical trials, including how the agency is coordinating with federal partners such as the U.S. Department of Veterans Affairs to streamline research pathways for populations with urgent unmet needs.
• Review Integrity and Subject-Matter Expertise – Whether qualified experts with relevant experience can conduct reviews of entactogen- and psychedelic-assisted therapies, along with steps in place to ensure consistency, objectivity and independence in the evaluation process.
• Final Guidance Timeline – The expected timeline for finalizing the FDA’s June 2023 guidance on clinical trials involving rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies.

Other questions revolve around strategies to mitigate functional unblinding and expectancy bias; standards for adverse event monitoring and safety reporting; provider training, licensing and participant safeguards; the evolving role of psychotherapy in conjunction with pharmacological intervention; general findings across diverse patient populations; and consistency in regulatory expectations.

Significant Progress but Work Remains

There are multiple bills as part of this expansive effort.

One previously reported by Military.com is the “Innovative Therapies Centers of Excellence Act of 2025” sponsored by U.S. Sen. Ruben Gallego (D-AZ), a U.S. Marine Corps veteran, that would designate not fewer than five VA medical facilities that can offer these different therapeutic modalities.

Another piece of legislation, Senate Bill 4220, also known as the Veterans Health Administration Novel Therapeutics Preparedness Act, was introduced March 27 by Navy SEAL veteran and U.S. Sen. Tim Sheehy (R-MT) and was co-sponsored by Gallego, Sen. Tammy Duckworth (D-IL), an Army National Guard veteran, and Sen. John Boozman (R-AR).

Juliana Mercer, executive director of Healing Breakthrough and a Marine Corps veteran, told Military.com that the new letter to the FDA’s Makary is “significant” considering the bipartisan nature of the request—which essentially calls for guidance on subject matter not fully vetted.

“It makes it hard for the data and the science that’s necessary to be out there in a way that’s going to make sure that the field moves quickly and that the FDA is able to move quickly,” Mercer said. “And quickly doesn’t mean recklessly. I think everybody agrees that we’re not asking them to cut any corners or lower the bar to approve anything prematurely.

“The letter explicitly recognizes that the FDA does have a responsibility to ensure safety and efficacy, but clarification on how the FDA is evaluating these new treatment models, questions around trial design.”

Asked about the Trump executive order, Mercer called it “historic” as it addresses not just psychedelic-based treatments but also addiction. The question is how the VA will implement all the guidance once ready. It’s “a major step in the right direction,” she said, adding that the “real challenge” is ahead to care for veterans.

“We can’t wait for a system, our current system, that moves at such a slow pace because veterans are dying. … We have the opportunity to start working now to build the infrastructure, to train clinicians at the VA, to start looking at reimbursement pathways and what the clinical delivery models should look like so that we ensure that these therapies are able to reach veterans safely and responsibly as soon as the FDA does approve them.”

She also said all of these pushes in the mental health space are not “happening in a vacuum” but complementary, whether it’s the initial Gallego bill or the one in the House.

But everything hinges on the FDA and its approval process, she added. That could dictate how the VA responds.

“I think the legislators are looking to hold them accountable,” she said. “Their pushback is their pushback, they’re the subject matter experts. But if they can’t produce what they are actually doing, our legislators are stepping up because they don’t believe that the VA is doing what needs to be done.

“So, whether or not [the FDA and VA are] doing it is not something that I can answer because they haven’t been clear as to what they’re working on.”