Seriously ill patients would finally be allowed to use marijuana — and potentially MDMA and psilocybin — without violating federal law under a congressionally approved bill now heading to President Trump’s desk.
The bill, know as the “Right to Try Act,” would give certain patients access to drugs that have not yet received U.S. Food and Drug Administration approval for broad use. The House voted 250 – 169 to pass the legislation on Tuesday, and it cleared the Senate by unanimous consent last August.
In order to qualify under the new program, a drug must have completed a phase 1 clinical trial, be under active development, and meet certain other criteria:
“(2) the term ‘eligible investigational drug’ means an investigational drug (as such term is used in section 561)—
“(A) for which a Phase 1 clinical trial has been completed;
“(B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act;
“(C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or
“(ii) that is under investigation in a clinical trial that—
“(I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and
“(II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and
“(D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and
Marijuana meets all of those criteria, thanks to research on medical cannabis use by military veterans with post-traumatic stress disorder that is being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS). That research is currently in Phase 2.
MDMA, commonly known as “ecstasy,” and psilocybin, the active ingredient in psychedelic mushrooms, have undergone Phase 1 and 2 clinical trials, with Phase 3 research on the way.
But while marijuana and potentially the other substances would be eligible for limited legal use under the new law once it is enacted, only patients who are seriously ill would be allowed to participate.
The legislation specifies that a qualifying patient must have been diagnosed with a life-threatening disease or condition, have exhausted approved treatment options and be unable to participate in the clinical trials themselves. A physician who is in good standing with a licensing board would then be able to certify the patient for access.
While the short title of the bill summarizes that it provides for the use of “unapproved medical products by patients diagnosed with a terminal illness in accordance with State law” (emphasis added), the legislative text itself provides no specific limitation concerning state laws. Thus, while patients who would otherwise qualify for medical cannabis access in their states would be clearly protected from federal harassment, it is somewhat of an open question as to whether the the use of psilocybin and MDMA, which are not legal for any use in any state, would be federally shielded.
That caveat aside, advocates are hopeful that the new law, when it is signed, could allow more patients to access substances that have until now only been available in limited clinical trials or through underground, unregulated therapy sessions.
“It seems passing Right to Try would grant people facing death across the country tremendous relief by allowing access to MDMA-therapy and psilocybin-therapy,” Natalie Lyla Ginsberg, MAPS’s policy and advocacy director, told Marijuana Moment in an email. “Both forms of psychedelic-therapy have been specifically researched as a treatment for anxiety associated with life-threatening illnesses, and have produced incredibly promising results, both for the patients and for their families and loved ones. We are hopeful Right to Try would inspire hospice centers to start integrating psychedelic therapy into their treatment.”
President Trump called on lawmakers to pass the legislation during his State of the Union address earlier this year.
“We also believe that patients with terminal conditions — terminal illness — should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It is time for the Congress to give these wonderful, incredible Americans the right to try.”
The House previously passed a similar bill in March (after it failed during a prior attempt). Rather than seek to reconcile the differences between the two chambers’ proposals via a conference committee, a process that would require further Senate action that seems doubtful given broad Democratic opposition, House GOP leaders decided to simply pass the other chamber’s bill in order to get it to the president.
Senate Schedules Hearing On Marijuana Business Banking Access
In one of the clearest signs of marijuana reform’s growing momentum on Capitol Hill, a Republican-controlled Senate committee has scheduled a hearing for next week that will examine cannabis businesses’ lack of access to banking services.
The formal discussion in the Senate Committee on Banking, Housing and Urban Affairs on Tuesday comes as legislation aimed at resolving the marijuana industry’s financial services problems is gaining momentum. A House cannabis banking bill that cleared that chamber’s Financial Services Committee with a bipartisan vote in March now has 206 cosponsors—nearly half the body—while companion Senate legislation has 32 out of 100 senators signed on.
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Congressman Files Marijuana Bill After Leaving Republican Party
In one of his first legislative acts since leaving the Republican Party earlier this month amid a feud with the president, Rep. Justin Amash (I-MI) filed a bill on Monday that would let states set their own marijuana policies without federal interference.
If that sounds familiar, it’s because bipartisan legislation that would accomplish the same goal has already been filed this Congress.
But unlike the nearly identical Strengthening the Tenth Amendment Through Entrusting States (STATES) Act, Amash’s new bill excludes one provision that would require the Government Accountability Office (GAO) to study the effects of cannabis legalization on road safety and issue a report on its findings within a year of the law’s enactment.
That language states that the GAO must study “traffic crashes, fatalities, and injuries” in legal cannabis states, actions taken by those states to “address marihuana-impaired driving,” testing standards being used to detect impaired driving and federal initiatives “aiming to assist States that have legalized marihuana with traffic safety.”
Given Amash’s libertarian leanings, it stands to reason that he opposes spending government dollars to conduct the research and simply supports the broader states’ rights intent of the original legislation.
That would also put him at odds with social justice advocates who feel that the STATES Act itself doesn’t go far enough and are pushing for more comprehensive legislation that includes additional provisions addressing social equity and restorative justice for people harmed by drug law enforcement.
Members of the House Judiciary Crime, Terrorism and Homeland Security Subcommittee heard that debate play out during a historic hearing on ending federal marijuana prohibition last week.
A newly formed coalition of civil rights and drug reform organizations, including the ACLU, is also insisting on passing wide-ranging legislation to deschedule cannabis entirely that also invests in communities that have been disproportionately impacted by prohibition.
Amash is a long-standing critic of the war on drugs and earlier this year signed on as a cosponsor of a separate bill that would federally deschedule marijuana. Rep. Tulsi Gabbard (D-HI), a 2020 Democratic presidential candidate, filed that legislation, which is also silent on social equity provisions.
— Justin Amash (@justinamash) March 8, 2019
Gabbard also introduced a separate bill that would require the U.S. Department of Health and Human Services and other federal agencies to study the impacts of legalization. True to form, Amash declined to add his name to that measure as well.
Read the text of Amash’s new cannabis bill below:
Photo courtesy of Kyle Jaeger.
Berkeley City Council Considers Decriminalizing Psychedelics This Week
A resolution to decriminalize psilocybin and other psychedelics will go before a Berkeley, California City Council committee on Wednesday.
Decriminalize Nature, the group behind the measure, also led the charge to successfully get a measure decriminalizing entheogenic plants and fungi approved by the City Council in neighboring Oakland last month.
In Berkeley, the Public Safety Committee will discuss the proposal and can either decide to hold it for a future meeting or advance it to the full Council. The public is able to attend Wednesday’s special meeting and share their perspective on the resolution, but Decriminalize Nature stressed in a tweet that this “is a small meeting, so you do NOT need to attend.”
Is it time for #DecriminalizeNature #Berkeley? Agenda 4 at the public safety meeting this Wed. July 17, with the Decriminalize Nature team! This is a small meeting, so you do NOT need to attend. But if you live in Berkeley, write your City Council! https://t.co/gMSDkegMPU
— Decriminalize Nature (@DecrimNature) July 15, 2019
However, city residents are being encouraged to write to their Council members and urge them to vote in favor of the measure, which would codify that “no department, agency, board, commission, officer or employee of the city, including without limitation, Berkeley Police Department personnel, shall use any city funds or resources to assist in the enforcement of laws imposing criminal penalties for the use and possession of Entheogenic Plants by adults of at least 21 years of age.”
The resolution defines the covered substances as “plants and natural sources such as mushrooms, cacti, iboga containing plants and/or extracted combinations of plants similar to ayahuasca; and limited to those containing the following types of compounds: indoleamines, tryptamines, phenethylamines.”
Councilmembers Rigel Robinson and Cheryl Davila are sponsoring the resolution, which does not allow for commercial sales or manufacturing.
The lawmakers provided background information on the measure in a report to their colleagues and the mayor, describing the medical potential of various psychedelics as well as the success of decriminalization measures in Denver and Oakland.
“It is intended that this resolution empowers Berkeley residents to be able to grow their own entheogens, share them with their community, and choose the appropriate setting for their intentions instead of having to rely exclusively on the medical establishment, which is slow to adapt and difficult to navigate for many,” they wrote.
While efforts to eliminate criminal penalties associated with psilocybin and other psychedelics have so far centered in jurisdictions that have historically embraced marijuana legalization and broader drug reform, the conversation around decriminalizing psychedelics is spreading nationally.
Shortly after Oakland approved its measure, Decriminalize Nature received inquiries from activities in cities from across the country. The group has kept track of each city where organizers are pursuing decriminalization.
Nature lovers are organizing coast to coast (and Hawaii)! Is your city on the map? Connect to join with your local community, or if you have the motivation to propose a similar initiative in your city/town/county, let’s start growing! contact [email protected] #DNUSA pic.twitter.com/38UxLKK9RN
— Decriminalize Nature (@DecrimNature) July 2, 2019
On Monday, a conversation around changing laws governing psychedelics reared during a City Council meeting in Columbia, Missouri. One resident implored the body to take up a resolution to decriminalize the natural substances, pointing to their therapeutic benefits.
Councilmember Mike Trapp said that the student’s proposal should be considered and that a government advisory board on public health should provide input on the medical potential of psychedelics, describing it as “very promising.”