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.
Hawaii Lawmakers Approve Marijuana Decriminalization Bill In Joint Committee Hearing
Two Hawaii Senate committees approved a bill to decriminalize the possession of small amounts of marijuana in a joint hearing on Tuesday.
The vote comes two weeks after the full House passed the amended legislation, which makes possession of three grams or less of cannabis a civil offense instead of a crime punishable by jail time. As approved by that full chamber, a first the offense was punishable by a $200 fine under the bill, but the Senate committees lowered it to $30 instead.
While the quantity of marijuana is significantly less than in other states have decriminalized, the development was welcomed by reform advocates in the state.
“[W]e embrace the move from criminalization that the bill still represents, and particularly applaud the provisions to dismiss pending charges and expunge convictions related to cannabis offenses,” the reform organization Drug Policy Forum of Hawaii, said in written testimony. “While we support full-scale legalization of adult use cannabis, this bill then also begins to reverse the brutal impact of the decades’ long, needless criminalization of this substance.”
The Senate Committee on Judiciary adopted the House recommendation without objection and advanced the bill. The Senate Committee on Public Safety, Intergovernmental, and Military Affairs didn’t immediately have a quorum during the joint hearing, so that panel didn’t formally take its vote until later in the day.
Besides decriminalizing low-level cannabis possession, the legislation would provide for the expungement of prior convictions cocerning three grams or less.
It would also establish a marijuana evaluation task force to “examine other states’ laws, penalties, and outcomes pertaining to marijuana use, other than marijuana use for medical purposes, and make recommendations on amending marijuana use penalties and outcomes in the State.”
Advocates are cautiously optimistic that Gov. David Ige (D) will sign the bill if it arrives on his desk. While he’s expressed concerns about adult-use legalization, he put his name on decriminalization legislation as a state senator in 2013.
On that note, a separate legalization proposal that advanced further than similar legislation has ever gone in Hawaii after it was approved by a Senate committee last month did not receive consideration in another panel before the deadline to proceed through the legislative process, which effectively killed the bill.
Elsewhere, New Mexico lawmakers sent a more wide-ranging decriminalization bill to the desk of Gov. Michelle Lujan Grisham (D) over the weekend. The pro-legalization governor is expected to sign the legislation.
Photo courtesy of Max Pixel.
First Congressional Marijuana Vote Of 2019 Officially Scheduled For Next Week
A bipartisan bill designed to protect banks that service the marijuana industry from being penalized by federal regulators will get a vote in a key congressional committee next week.
The legislation, which was discussed during the first cannabis-related hearing of the 116th Congress last month, will go before the House Financial Services Committee on Tuesday.
Reps. Ed Perlmutter (D-CO) Denny Heck (D-WA), Steve Stivers (R-OH) and Warren Davidson (R-OH) are the chief sponsors of the Secure and Fair Enforcement (SAFE) Banking Act. It was formally filed earlier this month, and currently has 138 cosponsors—more than a quarter of the House.
After no action for 6 years, #SAFEBanking has received its first hearing and will see its first vote next week. Glad to have the support of 138+ cosponsors as we work to address the #cannabis banking issue and get cash off our streets. https://t.co/jylk1udqVQ
— Rep. Ed Perlmutter (@RepPerlmutter) March 19, 2019
“For six years, Congress has failed to act on the issue of cannabis banking, putting thousands of employees, businesses and communities at risk,” Perlmutter said in a statement emailed to Marijuana Moment. “However, the issue is finally receiving the attention it deserves with the first-ever congressional hearing and now a scheduled committee vote.”
‘Among the cosponsors is the chair of the committee herself, Rep. Maxine Waters (D-CA), who spoke about addressing banking issues in the cannabis industry shortly before assuming the position. Judiciary Committee Chairman Jerrold Nadler (D-NY) and Rules Committee Chairman Jim McGovern (D-MA), have also signed onto the legislation—demonstrating its support among powerful Democratic leaders of the House.
All of this sets the stage for a potentially game-changing vote, as Republican leadership during the last Congress consistently blocked marijuana-related bills from even being considered. With Democrats in control and leading lawmakers embracing the legislation, it stands a good chance of heading to the full House and then on to the Senate.
Resolving banking problems for marijuana companies was one of several legislative goals that Rep. Earl Blumenauer (D-OR) outlined in a blueprint to end federal marijuana prohibition he sent to his party’s leaders last year.
“The banking issue is just one aspect of the failed policy of federal marijuana criminalization. In order to truly bring the marijuana industry out of the shadows, actions need to be taken by Congress to amend this, and many others, outdated and discriminatory practices,” Justin Strekal, political director for NORML, said in a statement. “This will certainly not be the last hearing of this Congress to discuss marijuana prohibition and we expect a full hearing on prohibition to be scheduled in the months to come.”
There were several changes made to the banking bill since it was last introduced in the 115th Congress. For example, the legislation clarifies that protections are extended to financial institutions that work with ancillary cannabis business—not just those that directly sell marijuana or marijuana products.
“[P]roceeds from a transaction conducted by a cannabis-related legitimate business shall not be considered as proceeds from an unlawful activity solely because the transaction was conducted by a cannabis-related legitimate business,” the bill states.
It also calls on the Federal Financial Institutions Examination Council to implement “uniform guidance and examination procedures for depository institutions that provide financial services to cannabis-related legitimate businesses.”
There have been widespread calls to tackle the banking problem, including from members of Congress and representatives of cannabis businesses. With this vote, it seems those calls are at least starting to be answered.
Meanwhile, Nadler has signaled that his Judiciary Committee may also take up broader marijuana legislation soon.
“With 97.7 percent of the U.S. population living in a state where voters have legalized some form of adult recreational, medical or limited-medical use of marijuana, congressional inaction is no longer an option,” Perlmutter said. “And with broad, bipartisan support in the House, I look forward to the SAFE Banking Act continuing to move forward in the Financial Services Committee and on the floor of the House.”
This story has been updated to include statements from Perlmutter and NORML.
Photo courtesy of Brian Shamblen.
Feds Ramp Up Calls For Research Into Marijuana Treatment For Chronic Pain
A federal health agency is seeking the public’s help in identifying studies that explore the potential benefits and harms of using marijuana instead of opioids for chronic pain treatment.
In three separate notices published in the Federal Register on Tuesday, the Agency for Healthcare Research and Quality (AHRQ) said it is in the process of reviewing existing research on chronic pain—specifically alternatives to opioid-based painkillers—and requested “supplemental evidence and data submissions” from the public.
The agency provided guidelines for what exactly it was interested in learning. One notice called for studies on the “comparative effectiveness” of using non-opioid therapies, “including marijuana,” instead of opioids. The studies should explore differences in “outcomes related to pain, function, and quality of life.” The filing also includes a prompt for evidence about utilizing cannabis in tandem with opioids, including how the harms of the prescription pain medications vary for patients who also use marijuana.
In another notice, AHRQ, which is part of the U.S. Department of Health and Human Services, said it wants help completing its review of non-invasive and non-pharmacologic chronic pain treatments such as exercise, mindfulness, acupuncture—and yes, medical marijuana. The request specified that the agency is interested in research on “any formulation” of cannabis.
Finally, a third notice included marijuana in a list of non-opioid pharmacologic treatment options that AHRQ is interested in exploring. The public is encouraged to submit studies and data on the risk of “overdose, misuse, dependence, withdrawals due to adverse events, and serious adverse events” for medical cannabis, as well as more conventional oral and topical treatments.
Altogether, the package of solicitations demonstrates that while marijuana remains a Schedule I drug (meaning the federal government does not recognize it as having medical value), there are federal agencies that are compelled by the prospect that cannabis effectively treats pain without the risks posed by opioids.
And there are any number of studies that AHRQ might want to take into consideration. For example, there are surveys that show patients often use marijuana as a substitute for opioid painkillers and other pharmaceuticals, as well as several comprehensive studies indicating that states with legal cannabis access experience lower opioid overdose rates and have fewer opioid prescriptions compared to non-legal states.
The deadline to submit studies and data for all of the new notices is April 18.
These are the latest in a series of notices that AHRQ and other federal agencies have published in recent months. Last year, the National Center for Complementary and Integrative Health hosted a workshop that specifically addressed barriers to cannabis research while the substance remains federally prohibited.
Photo courtesy of Philip Steffan.