U.S. lawmakers are pushing the FDA to approve MDMA, more commonly known as ecstasy or molly, to treat post-traumatic stress disorder.
A group of 61 representatives sent a letter to President Joe Biden Aug. 2, urging action on "the grave need for new and better treatment options" for PTSD.
In June, an FDA advisory panel voted 9-2 to recommend that MDMA, or midomafetamine, in combination with talk therapy is not effective to treat PTSD, and 10-1 that the risks of the therapy outweigh the benefits. The advisory panel expressed concerns about the validity of the drug's clinical trials.
Rep. Jack Bergman, the lawmaker leading the effort to convince the FDA to approve the drug, told Politico lawmakers are "gently but positively" leaning on the FDA.
"The strategy here is to put pressure in a positive way so that the bureaucracy feels it’s OK to assume some risk," Mr. Bergman told the outlet.
In the letter, lawmakers wrote that while critics of the treatment "may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA."
Lykos Therapeutics, the company that developed the treatment, said it would implement additional oversight if it is approved by the FDA. In an Aug. 1 news release, Lykos said it would establish an independent advisory board to inform the potential commercial launch of the drug.
The FDA is expected to issue a final decision on the drug by Aug. 11, according to Politico. If approved, it would be the first new treatment for PTSD in 25 years.