Lawmakers are boosting efforts to secure psychedelic treatments for veterans after an FDA advisory committee this month overwhelmingly recommended against what would be the first such drug approval in the U.S.

Why it matters: Some veterans and others living with post-traumatic stress disorder say MDMA along with psychotherapy has reduced their symptoms.

• But there's limited data to judge the safety and effectiveness of such substances.

Driving the news: Members are using the annual defense authorization bill and the appropriations process to advance the cause, noting that FDA advisers faulted the sponsoring company's trial design but found hallucinogenics could have some medical benefit.

• Rep. Nancy Mace submitted a bipartisan amendment to this year's NDAA which would have enabled the Drug Enforcement Administration to change substances such as MDMA from Schedule I to Schedule II, making it easier to conduct research.
• The House Appropriations MilCon-VA bill that passed this month also contained two amendments on psychedelics that were adopted with little debate.
• One expressed congressional support for VA-funded research into psychedelic-assisted therapies and encouraged the VA to start proactively training therapists in the event the FDA approves an MDMA treatment.
• The other ordered a report to Congress on psychedelic treatments being added to the department's formulary.

What they're saying: "The VA is already doing pilot studies on this in their research and innovation, so we continue to ask them to consider this treatment" Rep. Mariannette Miller-Meeks told Axios. "So far it looks to be safe and it doesn't have the addictive potential as other medications."

• Among the most prominent voices is Rep. Morgan Luttrell, a former Navy Seal who's been outspoken about how psychedelic therapies helped him cope with a traumatic brain injury from a helicopter crash.
• "For the United States to make progress in this field, we must continue to fund research to expand our understanding of the mechanisms behind psychedelic-assisted therapy and its long-term effects," he wrote in a blog post last week.

The intrigue: Rep. Dan Crenshaw, another supporter, cited the difficulty of doing trials on such substances, because the drugs' notable effects would make it instantly recognizable to patients who got them instead of a placebo, and could raise their expectations of benefitting from the treatment.

• "I think FDA needs to recognize that it's very hard to design a trial with a placebo with psychedelics, you can't do that," he said.

What's next: The FDA is expected to make a final decision on Lykos Therapeutics' application to use ecstasy with psychotherapy for PTSD by Aug. 11.

• 9 out of 11 outside advisers this month voted against recommending approval, citing concerns about missing safety data and flaws in the clinical trial design.

Go deeper.

Here are some more details on the NIH reorganization plan our Vitals colleagues told you about this morning:

• It would streamline the 27 existing institutes and centers into 15, in part to "eliminate the demographic- or disease-specific siloed nature of the current structure."
• NIAID, a focus of partisan debates over COVID and the pandemic response that received $6.56 billion in FY24 funding, would be divided into a National Institute on Infectious Diseases and an institute on the immune system and arthritis, each receiving $3.3 billion in funding.
• Every institute and center director would be limited to a five-year term, with the ability to serve two, consecutive terms, if approved by the NIH director.
• The plan would establish a congressionally mandated commission to review the NIH's performance and recommend improvements.
• There are requirements for NIH officials to report and disclose royalty payments and other third-party financial benefits, including support from and affiliations with foreign institutions.

What they're saying: Republican leaders say that House FY25 spending bills would reflect some of the proposed reforms.

More here.

1. COVID origins: The Senate Homeland Security and Governmental Affairs Committee holds a hearing Tuesday at 10am ET titled "Origins of COVID-19: An examination of available evidence."

2. Disability benefits: The Senate Finance Committee has a hearing Tuesday at 10am ET on work and Social Security disability benefits.

3. GLP-1 news: The American Diabetes Association's annual meeting, which kicks off Friday in Orlando, should provide a forum for assessing further innovation in anti-obesity drugs.