Bipartisan Lawmakers Press FDA on Psychedelic Therapy Reviews After Trump Executive Order

Thirty-two House Republicans and Democrats sent a letter to FDA Commissioner Martin Makary on May 1 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 days after President Donald Trump signed an executive order on April 18 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.

The missive asked 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 a Special Protocol Assessment. U.S. Department of Veterans Affairs.

They inquired whether qualified experts with relevant experience can conduct reviews of entactogen- and psychedelic-assisted therapies and what steps are in place to ensure consistency, objectivity and independence in the evaluation process. The letter requested 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.

Additional questions addressed 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.

More than two dozen lawmakers are calling on the FDA to expedite review of mental health therapies including psychedelics as part of multiple pieces of legislation drafted in the House and Senate. Those measures aim to provide more expansive treatment options for civilians, current and former military service members with PTSD, depression and suicide.

U.S. Sen. Ruben Gallego (D-AZ), would designate not fewer than five VA medical facilities that can offer therapeutic modalities including psychedelics. Senate Bill 4220, also known as the Veterans Health Administration Novel Therapeutics Preparedness Act, was introduced on March 27 by Sen.

Tim Sheehy (R-MT). It was co-sponsored by Sen. Ruben Gallego (D-AZ), Sen. Tammy Duckworth (D-IL), and Sen. John Boozman (R-AR). Sen. U.S. Marine Corps veteran, Sen. Tim Sheehy is a Navy SEAL veteran, and Sen.

Tammy Duckworth is an Army National Guard veteran. com that the new letter to the FDA’s Makary is “significant” considering the bipartisan nature of the request. She called the Trump executive order “historic” as it addresses not just psychedelic-based treatments but also addiction.

Com reported on the different legislative efforts that center on expanding treatment options for those experiencing elevated rates of PTSD, depression and suicide. Mercer noted that all of these pushes in the mental health space are complementary, whether the initial Gallego bill or the one in the House.

She said legislators are looking to hold agencies accountable in an area where veterans cannot wait for slow-moving systems.