Lawmakers push FDA to approve MDMA-assisted therapy for PTSD 

MDMA-assisted therapy, or ecstasy, could face a major hurdle on Sunday when the Food and Drug Administration (FDA) is slated to make a decision on whether to give the psychedelic approval for post-traumatic stress disorder (PTSD) treatment.

In advance of the decision, U.S. lawmakers, spearheaded in the House by Rep. Jack Bergman (R-Watersmeet), sent letters to President Joe Biden and FDA Commissioner Robert Califf urging approval of the treatment.

MDMA-assisted therapy for PTSD has been heralded as a treatment with the potential to reduce the number of veterans dying by suicide, a demographic that is disproportionately impacted by PTSD.

U.S. lawmakers, advocates ask FDA to approve use of psychedelics for PTSD treatment

“Psychedelic assisted therapies have the potential to be the first genuine advancement in the treatment of veterans’ mental health in decades,” Bergman said during a press conference last month. 

The letter from the House garnered 61 signatures, and 19 senators signed another letter. Both requests received bipartisan support. 

Sen. Gary Peters (D-Bloomfield Twp.) signed on to the Senate’s letter addressed to Califf. Bergman, Rep. Bill Huizenga (R-Zeeland), Rep. Elissa Slotkin (D-Holly) and Rep. John James (R-Shelby Twp.) put their names on the House letter sent to Biden. Three have military service; Peters in the Navy, Bergman in the Marines and John James in the Army. Slotkin also served as a CIA analyst and did three tours in Iraq. 

A stumbling block for the treatment’s approval came earlier this summer when a panel of advisers for the FDA rejected the use of psychedelic-assisted therapy. The advisory panel cited a lack of substantial research and possible health side effects. 

The lack of endorsement does not mean the FDA will not approve the therapy, but the agency overwhelmingly tends to side with the advisers. 

A study from Nature Medicine, a peer-reviewed medical journal, found ecstasy can ease the symptoms of PTSD in a diverse population. Seventy-one percent of the 52 people who received MDMA-assisted therapy lost their diagnosis after three sessions, according to the study. Lykos Therapeutics, the drugmaker, handled the study.

In reporting from the Wall Street Journal published Monday, three study subjects said that their mental health worsened from the treatment, a side effect researchers did not reflect in the final report. They also described pressure from therapists involved in the study to respond positively to the treatment.

Lawmakers and veterans advocates pushed for approval in July during a press conference, saying the treatment was vital for saving the lives of people with PTSD.

“I want to remind the FDA, those in the administration, that every day you wait, every day you put this off, is another 17 to 44 veterans,” U.S. Rep. Lou Correa (D-Calif.) said during the press conference. “They’re losing lives on a daily basis.”