Bipartisan and bicameral congressional lawmakers have filed an updated version of a bill to streamline the federal rescheduling of “breakthrough therapies” like psilocybin and MDMA in order to promote research and drug development.
Sens. Cory Booker (D-NJ) and Rand Paul (R-KY)—along with Reps. Madeleine Dean (D-PA) and Nancy Mace (R-SC)—announced on Thursday the introduction of the “Breakthrough Therapies Act.”
The legislation proposes to amend the federal Controlled Substances Act (CSA), in part by creating a procedure through which current Schedule I drugs that are deemed breakthrough therapies by the Food and Drug Administration (FDA), or qualify for a waiver under the federal Food, Drug, and Cosmetic Act (FDCA), could be transferred to a lower schedule that would make them easier to study and promote drug development.
When a drug meets either of those criteria, they would be placed in Schedule II, which is reserved for drugs with “currently accepted medical use with severe restrictions.”
“According to recent studies, certain Schedule I substances such as MDMA and psilocybin could offer major advancements in the treatment of depression, severe post-traumatic stress disorder, and addiction,” Booker said in a press release. “This bill will eliminate unreasonably burdensome rules and regulations that delay or prevent researchers from studying these breakthrough mental health treatments, and will provide access to these promising therapies for eligible patients who urgently need care.”
Paul added that, as a physician, he’s “proud to co-lead this legislation with Senator Booker to get the government out of the way and expand compassionate medical use for patients in need of care.”
The bill was amended from its earlier version filed last Congress to exclude sections on simplifying the registration process for researchers seeking to investigate Schedule I drugs. Scientists have long complained about the onerous process to receive Drug Enforcement Administration (DEA) approval for such studies—an issue that was addressed with respect to marijuana specifically under a bill signed by President Joe Biden last year.
Also, the new legislation now includes a new section that says any drug moved from Schedule I to Schedule II under the breakthrough therapy or FDCA waiver standards could be placed back in the strictest category if it “no longer has a currently accepted medical use with severe restrictions” and the head of the U.S. Department of Health and Human Services (HHS) recommends it to the attorney general.
If that happens, “the Attorney General shall, not later than 90 days after receiving written notification from the Secretary, issue an interim final rule controlling the drug,” the bill text says.
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“Breakthrough therapies give us the opportunity to improve the lives of all those suffering from treatment-resistant mental illnesses. It is our duty to make sure veterans have access to every possible treatment option that shows promise, including MDMA- and psilocybin-assisted therapies,” Mace said. “This legislation will remove the bureaucratic hurdles which have hindered critical research and compassionate use of potentially lifesaving therapies.”
Dean said that the nation’s issues with mental health and substance use disorders makes clear that “Congress has a role to play to ensure that our loved ones, including our veterans, have access to treatment options.”
“Our bipartisan legislation reduces barriers that will enable better research and compassionate use of two innovative and potentially lifesaving treatments—MDMA and psilocybin,” the congresswoman said. “We must always work to break stigma and help make recovery possible for more people.”
Booker, Paul and Mace also led a separate bill last year that was designed to clarify that federal “Right to Try” (RTT) laws give seriously ill patients access to Schedule I drugs, including marijuana and psychedelics like psilocybin and MDMA. It was not enacted by the end of the session, however.
The introduction of the new bipartisan psychedelics bill roughly coincided with the re-launch of a congressional caucus focused on promoting research into the therapeutic potential of entheogenic substances.
The renamed Congressional Psychedelics Advancing Therapies (PATH) Caucus is being led by Reps. Lou Correa (D-CA) and Jack Bergman (R-MI).
But these developments also come amid an unprecedented wave of state-level psychedelics reform efforts in legislatures across the country. Legislators in more than a dozen states are pursuing the issue this session are interest rapidly spreads into the medical potential of these substances.
Read the text of the Breakthrough Therapies Act below:
Photo courtesy of Dick Culbert.
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