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.
Virginia Has Sealed 64,000 Marijuana Distribution Charges Since Legalization Took Effect This Summer
“These aren’t just numbers and there are families attached.”
By Ned Oliver, Virginia Mercury
Virginia has sealed records documenting more than 64,000 misdemeanor marijuana distribution charges since the state legalized the drug in July.
The figure came out Thursday during a meeting of the legislature’s Cannabis Oversight Commission.
Officials said the records were scrubbed from the state’s criminal record database, which is used by employers like school boards, state agencies and local governments to screen employees.
The state had already sealed 333,000 records detailing charges of simple possession last year after the state reduced the offense to a civil infraction on par with a traffic offense, said Shawn G. Talmadge, the Deputy Secretary of Public Safety and Homeland Security.
Lawmakers directed the state to expand that effort when they voted to broadly legalize recreational use of marijuana earlier this year.
The legislature also agreed to a broader expungement reform that will automatically seal other misdemeanor charges, including underage possession of alcohol, use of a fake ID, petit larceny, trespassing and disorderly conduct. Talmadge said those charges will remain in the system until the state finishes updating the software it uses to track criminal records.
“As of right now, the process is proceeding,” he said.
The Virginia Joint Commission on Cannabis Oversight is meeting now. You can find the agenda and links to livestream and to provide public comment at https://t.co/f1wsPn7SV7
— Jennifer McClellan (@JennMcClellanVA) October 14, 2021
Members of the oversight commission also heard from two advocates who urged them to move fast to address people currently imprisoned for marijuana offenses—a category of people the legalization legislation passed this year did not address.
Chelsea Higgs Wise, the leader of the advocacy group Marijuana Justice, and Gracie Burger, with the Last Prisoner Project, said Department of Corrections data suggests there are currently 10 people being held solely on serious marijuana charges.
They said it remains unknown how many more are being held because of marijuana related probation violations.
“These aren’t just numbers and there are families attached,” Burger said.
DEA Proposes Dramatic Increase In Marijuana And Psychedelic Production In 2022, Calling For 6,300 Percent More MDMA Alone
The Drug Enforcement Administration (DEA) is proposing a dramatic increase in the legal production of marijuana and psychedelics like psilocybin, LSD, MDMA and DMT to be used in research next year.
In a notice scheduled to be published in the Federal Register on Monday, the agency said there’s been a “significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” and it wants authorized manufacturers to meet that growing demand.
DEA had already massively upped its proposed 2021 quota for cannabis and psilocybin last month, but now it’s calling for significantly larger quantities of research-grade marijuana and a broader array of psychedelics to be manufactured in 2022.
It wants to double the amount of marijuana extracts, psilocybin and psilocyn, quadruple mescaline and quintuple DMT. What especially stands out in the notice is MDMA. The agency is proposing an enormous 6,300 percent boost in the production of that drug—from just 50 grams in 2021 to 3,200 grams in the coming year—as research into its therapeutic potential continues to expand.
LSD would see a 1,150 percent increase, up to 500 grams of the potent psychedelic.
Marijuana itself would get a 60 percent boost under DEA’s proposal, up to 3.2 million grams in 2022 from the 2 million grams last year.
Here’s a visualization of the proposed quota increase from 2021 to 2022 for marijuana and cannabis extracts:
For all other THC, psilocybin, psilocyn and MDMA:
And for other psychedelic substances like LSD, mescaline and DMT:
DEA said in the Federal Register notice that it has been receiving and approving additional applications to “grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes” to achieve these ambitious quotas.
“DEA supports regulated research with schedule I controlled substances, as evidenced by increases proposed for 2022 as compared with aggregate production quotas for these substances in 2021,” the agency said, adding that it working “diligently” to process and approve marijuana manufacturers applications in particular, as there’s currently only one farm at the University of Mississippi that’s permitted to cultivate the plant for research.
“Based on the increase in research and clinical trial applications, DEA has proposed increases in 3,4- Methylenedioxyamphetamine (MDA), 3,4-Methylenedioxymethamphetamine (MDMA), 5-Methoxy-N,N-dimethyltryptamine, Dimethyltryptamine, Lysergic acid diethylamide (LSD), Marihuana, Marihuana Extract, Mescaline, Psilocybin, Psilocyn, and All Other Tetrahydrocannabinols to support manufacturing activities related to the increased level of research and clinical trials with these schedule I controlled substances.”
Here are the exact numbers for the proposed 2021 and 2022 quotas:
|All other tetrahydrocannabinol||1,000||2,000|
A 30-day public comment period will be open after the notice is formally published on Monday.
It’s difficult to overstate just how significant the proposed 2022 increases are, but it’s certainly true that scientific and public interest in marijuana and psychedelics has rapidly increased, with early clinical trials signaling that such substances show significant therapeutic potential.
National Institute on Drug Abuse (NIDA) Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s previous proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.
Advocates and experts remain frustrated that these plants and fungi remain in the strictest federal drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.
A federal appeals court in August dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act. However, one judge did say in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana.
Separately, the Washington State attorney general’s office and lawyers representing cancer patients recently urged a federal appeals panel to push for a DEA policy change to allow people in end-of-life care to access psilocybin under state and federal right-to-try laws.
Image element courtesy of Kristie Gianopulos.
Supreme Court Won’t Hear Case On Legalizing Safe Drug Consumption Sites, But Activists Are Undeterred
The U.S. Supreme Court (SCOTUS) has rejected a request to hear a case on the legality of establishing safe injection sites where people can use illicit drugs in a medically supervised environment.
The justices announced on Tuesday that they decided against taking up the case raised by the nonprofit Safehouse, despite the pleas of attorneys general from 10 states and D.C. who recently filed amici briefs urging the court’s involvement.
Representatives from 14 cities and counties, as well as the mayor of Philadelphia, which is at the center of the current case, also filed briefs in support of the case in recent days.
Safehouse was set to launch a safe consumption site in Philadelphia before being blocked by a legal challenge from the Trump administration. It filed a petition with the nation’s highest court in August to hear the case.
But while the Supreme Court declined to take action—and the Biden administration passed up its voluntary opportunity to weigh in at this stage, which may well have influenced the justices’ decision—activists say the battle will continue at a lower federal court level, where the administration will have to file briefs revealing its position on the issue.
Disappointed but not surprised U.S. Supreme Court declined to hear our case. We’re pursuing our claims in federal court. As that litigation proceeds, Biden administration will have to take a position, which it avoided by waiving its right to respond to our Supreme Court petition.
— Safehouse (@SafehousePhilly) October 13, 2021
“We were disappointed that the government chose not to respond to our petition,” Safehouse Vice President Ronda Goldfein told Filter. “They said, ‘We’re going to waive our right to respond,’ [and] the Supreme Court declined to review our case. Ordinarily that sounds like the end of the road—but in our case we are still pursuing our claims in a different venue.”
That venue will be the the federal district court in Philadelphia, where activists plan to submit multiple arguments related to religious freedom and interstate commerce protections. The Biden administration will be compelled to file a response in that court by November 5.
“If they don’t respond, they lose,” Goldfein said.
A coalition of 80 current and former prosecutors and law enforcement officials—including one who is President Joe Biden’s pick for U.S. attorney of Massachusetts—previously filed a brief urging the Supreme Court to take up Safehouse’s safe injection case.
Fair and Justice Prosecution, the group that coordinated the amicus brief, also organized a tour of Portugal for 20 top prosecutors in 2019 so they could learn about the successful implementation of the country’s drug decriminalization law.
If the Supreme Court were to have taken the case and rule in favor of Safehouse, it could have emboldened advocates and lawmakers across the country to pursue the harm reduction policy.
The governor of Rhode Island signed a bill in July to establish a safe consumption site pilot program where people could test and use currently illicit drugs in a medically supervised environment. It became the first state in the country to legalize the harm reduction centers. It’s not clear whether the Department of Justice will seek to intervene to prevent the opening of such facilities in that state.
Massachusetts lawmakers advanced similar legislation last year, but it was not ultimately enacted.
A similar harm reduction bill in California, sponsored by Sen. Scott Wiener (D), was approved in the state Senate in April, but further action has been delayed until 2022.