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.
Hemp Farmers Guaranteed Federal Crop Insurance Through Disaster Bill Amendment
The Senate approved a bill on Thursday that is mostly focused on providing relief aid to areas impacted by natural disasters—but it also includes a provision ensuring that hemp farmers qualify for federal crop insurance.
The hemp section was inserted into the legislation at the behest of Senate Majority Leader Mitch McConnell (R-KY). Though similar language already exists in the 2018 Farm Bill, which federally legalized hemp and its derivatives, the senator took an added measure to provide clarity to farmers who want access to the insurance option ahead of the 2020 planting season.
“Beginning not later than the 2020 reinsurance year, the Federal Crop Insurance Corporation shall offer coverage under the wholefarm revenue protection insurance policy (or a successor policy or plan of insurance) for hemp (as defined in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o)),” text of the provision states.
“Provided, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985,” it continues.
The Senate passed the bill by a vote of 85 to 8. The House is expected to approve the disaster legislation by unanimous consent by the end of the week, and President Donald Trump has offered assurances that he will sign it into law.
The legalization of hemp has sparked strong interest among farmers in states from Colorado to Kentucky, but it will still be some time until the U.S. Department of Agriculture (USDA) develops and implements its federal regulatory guidelines.
Agriculture Secretary Sonny Perdue said that while his department would not rush its rulemaking process, it still intends to implement the regulations before the 2020 planting season. After that point, USDA would be able to approve regulatory plans submitted by individual states.
McConnell, who championed the hemp legalization provision, has urged the quick and effective implementation of such regulations, and he’s suggested that he’d introduce standalone legislation to resolve any “glitches” in its rollout.
While not a standalone bill, the hemp-focused provision of the disaster legislation seems to indicate he plans to make good on that promise.
The senator has made much of his pro-hemp agenda, arguing last month that his role in reforming hemp laws is at “the top of the list” of reasons why voters should reelect him in 2020. He also cited hemp as an agricultural alternative to tobacco when he introduced a bill this week to raise the minimum age requirement to purchase tobacco products from 18 to 21.
Congressional Report Urges DEA Action On Marijuana Cultivation Applications
A congressional committee report attached a large-scale spending bill containing marijuana-related protections has been amended to include a call for the Drug Enforcement Administration (DEA) to finally act on long-pending applications for federal licenses to grow cannabis for research purposes.
The legislation itself, which was released by a House subcommittee last week, could still be further amended as it goes through the legislative process. But as approved by the full House Appropriations Committee on Wednesday, the bill stipulates that none of the Fiscal Year 2020 funds it allocates may be used by the Justice Department to interfere in state-legal medical marijuana programs.
The provision has been federal law since 2014, but its inclusion in the initial subcommittee proposal as introduced is the earliest it has ever surfaced in the legislative process for the annual spending bill. While advocates hoped broader protections for adult-use cannabis states would also be included in the base legislation, that rider isn’t in the bill—at least not yet.
There was also a technical problem with the legislation that wasn’t resolved by the committee manager’s amendment, the text of which has not been posted but was obtained by Marijuana Moment. The medical cannabis provision lists the states and territories its protections apply to—but it left out the U.S. Virgin Islands, which legalized medical marijuana in January.
Similar errors have occurred in past versions of the legislation, when legal medical cannabis states North Dakota and Indiana were not included in an earlier version of the rider, and advocates hope that the language will be amended on the House floor.
But while that fix didn’t make it into the bill at the committee level, the directive to the DEA about cannabis cultivation licenses was added to the committee report attached to the bill via the manager’s amendment.
“The Committee urges the Drug Enforcement Administration to expeditiously process any pending applications for authorization to produce marijuana exclusively for us in medical research,” the revised report states.
The DEA has faced significant pressure from lawmakers, advocates and scientists to approve applications for additional marijuana manufacturers to produce research-grade cannabis. Currently there is only one federally authorized facility, and the quality of its product has long been criticized.
DEA announced a process to license additional cultivators during the final months of the Obama administration in 2016, but the Justice Department under then-Attorney General Jeff Sessions refused to act on more than two dozen pending applications. Current Attorney General William Barr has pledged to look into the matter, and has said he agrees that approving additional manufacturers is necessary.
Advocates hope that the new committee report language could help to finally spur movement at the department.
“The DEA is a disaster on marijuana and they need to stop obstructing research ASAP,” Michael Collins, director of national affairs for the Drug Policy Alliance, told Marijuana Moment.
“It’s beyond ridiculous that they won’t act on these applications. Even prohibitionists like Project SAM agree,” he added, referring to the anti-legalization group Smart Approaches to Marijuana. “And when the guys who get their drug policy from the 1920s say you’re behind the times, that’s pretty embarrassing.”
Justin Strekal, political director for NORML, said that Sessions “was the only government official opposed to cannabis research, and he is no longer employed.”
“Now is the time for AG Barr to follow through on his commitment and allow researchers pathways to consumer-grade cannabis,” he said.
Another provision included in the appropriations bill would offer protections for states that have implemented industrial hemp pilot programs under the 2014 Farm Bill. The Justice Department wouldn’t be allowed to use its funds to interfere in such programs under the proposal.
Of course, the 2018 version of the agriculture legislation removed hemp and its derivatives from the Controlled Substances Act, shifting regulatory responsibility onto the U.S. Department of Agriculture instead of the Justice Department, so that provision may not be especially relevant going forward.
The bill will next head to the Rules Committee, which will decide the list of amendments—potentially including additional cannabis-related ones—that can be considered on the House floor.
Read the text of the manager’s amendment with the DEA marijuana language below:
Managers Amendment FINAL by on Scribd
Photo courtesy of Mike Latimer.
House Committee Approves Immigration Bill With Marijuana Protections
A congressional committee voted in favor of a wide-ranging immigration bill on Wednesday, and the legislation includes marijuana-related protections for people who were brought to the U.S. as children.
Under the DREAM Act as approved, having low-level cannabis convictions, or engaging in state-legal cannabis-related activities such as working in the regulated marijuana industry, would not be counted against applications for permanent resident status for so-called Dreamers.
The House Judiciary Committee advanced the bill in a 19-10 vote, without specific discussion about the cannabis provisions.
The section concerning eligibility for permanent status stipules that having three or more misdemeanor convictions could be grounds for ineligibility—but the bill creates an exemption for “simple possession of cannabis or cannabis-related paraphernalia” or “any offense involving cannabis or cannabis-related paraphernalia which is no longer prosecutable in the State in which the conviction was entered.”
The text seems to indicate that immigrants who engaged in cannabis-related activities prior to a state reforming its marijuana laws would still be protected even if that activity was not state-legal at the time.
Similar language appears under a separate section about grounds for a provisional denial of an application for adjustment of status. Applicants would be exempted from such a denial if their conviction was for “simple possession of cannabis or cannabis-related paraphernalia” or “any offense involving cannabis or cannabis-related paraphernalia which is no longer prosecutable in the State in which the conviction was entered.”
A previous version of the legislation, filed in March, didn’t include the specific eligibility requirements related to certain criminal activity, nor did it contain any explicit marijuana protections. It’s possible that House Democrats thought up the exemptions during a brainstorming session earlier this month about potential bill revisions aimed at building more support.
The next likely stop for the DREAM Act will be the House Rules Committee before heading to a full floor vote.
There’s been growing interest in reforming marijuana policies as they apply to immigrants and visitors to the U.S.
Earlier this month, four congressional Democrats sent a letter to the head of the Justice Department and Department of Homeland Security to end the practice of rejecting naturalization applications solely because the applicant worked in a state-legal marijuana market. That came after the U.S. Citizenship and Immigration Services (USCIS) released a memo specifying that such activity could render them morally unfit for citizenship.
And last week, Rep. Earl Blumenauer (D-OR) introduced legislation aimed at resolving marijuana-related border issues, whereby visitors who admit to using cannabis or working in their country’s legal industry can be denied entrance.
Photo courtesy of Philip Steffan.