A Republican-backed bill working its way through Congress could have the unintended consequence of allowing seriously ill patients to use medical marijuana.
Under legislation set to be voted on by the House of Representatives on Tuesday, patients with terminal diseases would be able to access drugs that have not yet been approved by the Food and Drug Administration. The proposal, known as the “Right to Try Act,” lays out certain criteria for what can be considered an “eligible investigational drug,” all of which marijuana appears to meet.
The proposal, known as the “Right to Try Act,” lays out certain criteria for what can be considered an “eligible investigational drug,” all of which marijuana appears to meet.
In order to qualify, a drug has to have completed a phase 1 clinical trial, be under active development and not yet have been approved or licensed for any legal use by the federal government. An eligible medicine also needs to be the subject of an active investigational new drug application and under investigation in a clinical trial intended to form the basis of a claim of effectiveness in support of approval or licensure by the FDA.
Thanks to research being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), cannabis seems to fit the bill.
The organization, which began its quest for investigational new drug status for marijuana in 2010, is currently in the middle of Phase 2 clinical trials on the use of cannabis by military veterans with post-traumatic stress disorder. The goal is to turn whole-plant marijuana into a legal, FDA-approved prescription medicine.
In the meantime, while the congressional bill appears to open the door to legal access to marijuana, only the most gravely ill patients would qualify.
To access cannabis, they would need to be in “a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death.”
They would also need to have “exhausted approved treatment options” and not be eligible to otherwise participate in ongoing clinical trials on the drug because they don’t meet inclusion criteria or live within geographic proximity of where the study is taking place.
“Making medical marijuana available for terminally ill patients would certainly be a significant step forward for federal policy. If MAPS’s current Phase 2 clinical trial of marijuana for symptoms of PTSD in military veterans qualifies marijuana for use under the proposed Right to Try Act, then the trial will already have helped a lot of people,” Brad Burge, MAPS’s director of strategic communications, said in an interview. “Still, only making marijuana available for those on the verge of dying isn’t nearly enough, and the best thing the federal government can do for patients is to end the federal monopoly on marijuana for research currently being upheld by Jeff Sessions.”
Under longstanding U.S. policy, all marijuana used in scientific research is grown at a University of Mississippi farm licensed by the National Institute on Drug Abuse. Researchers have long complained that it is difficult to obtain cannabis from the government-sponsored lab and that the product is often of low quality. In 2016, the Obama administration moved to allow more cultivation facilities, but the Department of Justice under U.S. Attorney General Jeff Sessions has reportedly blocked the Drug Enforcement Administration from acting on any of the license applications it has so far received.
Because the Right to Try bill is being brought forth on an expedited basis known as “suspension of the rules,” it needs support from two-thirds of House members present and voting, with a roll call expected to take place Tuesday evening. A similar bill was approved by the Senate last August.
If the House passes the legislation, the two chambers will work to reconcile the versions into a single proposal to be sent to President Trump, who pledged his support during his State of the Union address in January.
Republican and Democratic staffers for the House Energy and Commerce Committee, which has jurisdiction over food and drug safety, did not respond to a request for comment.
UPDATE: The bill fell just short of getting the necessary two-thirds support it needed to pass the House under suspension of the rules on Tuesday evening.
Alexandria Ocasio-Cortez Presses Housing Secretary About Marijuana Eviction Policies
Rep. Alexandria Ocasio-Cortez (D-NY) pressed the head of the Department of Housing and Urban Development (HUD) about policies that cause public housing residents and their families to be evicted for committing low-level offenses such as marijuana possession on Tuesday.
During a hearing before the House Financial Services Committee, the congresswoman first quoted HUD Secretary Ben Carson from a 2017 speech where he acknowledged that the war on drugs has disproportionately impacted minority communities.
“Do you acknowledge that the war on drugs disproportionately impacted black communities and communities of color despite marijuana and other drug use levels being comparable to white communities?” she asked the secretary for the record.
“Traditionally that has been the case,” Carson replied.
@SecretaryCasron: "I'm always in favor of more flexibility." pic.twitter.com/7ze07GqZc9
— CSPAN (@cspan) May 21, 2019
Ocasio-Cortez went on to say that she was concerned that “the negative impact of the war on drugs has not been limited to incarceration” and that “we had legislative rippling effect that also seems to have been codified in our housing system”
She pointed to two specific HUD policies: the “one strike” rule, which allows property managers to evict people living in federally assisted housing if they engage in illicit drug use or other crimes, and the “no fault” rule, which stipulates that public housing residents can be evicted due to illicit drug use by other members of their household or guests—even if the resident was unaware of the activity.
Carson said that property owners in individual jurisdictions have discretion when it comes to enforcing the policy, but he conceded that these rules are in effect under federal law.
“So a person could be stop and frisked and be found in possession of a small amount of marijuana and then be evicted or have their entire family evicted from public housing?” Ocasio-Cortez asked.
“That is a possibility,” Carson said.
Who says progressives can’t get stuff done?
Thank you @SecretaryCarson for your testimony in front of the Financial Services Committee today.
We have many crises in housing, & I look forward to reversing the unjust legacy laws from the War on Drugs in our public housing system. https://t.co/ZK8aFsyIxo
— Alexandria Ocasio-Cortez (@AOC) May 21, 2019
The congresswoman then asked if Carson was aware of the “no fault” rule, to which he replied that the “use of such activity is extremely limited, if ever used.” Ocasio-Cortez responded by stating that the policies “are still codified in federal law” and asked whether the official supports “reversing some of these provisions” such as the “no fault” rule.
Carson said he was willing to talk about individual cases, and the congresswoman followed up by noting that there’s a lack of holistic review for these cases. Given Carson’s interest in hearing details about individual cases, she wondered if he’d “support being able to move some of these policies to a more holistic review.”
“Should that case-by-case consideration be codified in federal law instead of having blanket, one-strike or no fault policies?” she asked.
“I’m always in favor of more flexibility,” he said, signaling that he’d be open to reforming some of the anti-drug policies in effect federally at HUD.
Should Carson decline to take action, legislation introduced by Rep. Eleanor Holmes Norton (D-DC) in April would protect public housing residents who use marijuana in compliance with state law from being evicted.
Ocasio-Cortez herself has filed a bill that would prevent public housing applicants from being denied due to a low-level drug conviction that resulted in a sentence of under ten years and prohibit drug testing of applicants “as a condition of such housing assistance,” among other reforms.
Photo courtesy of C-SPAN.
Presidential Candidates Are Cosponsoring A New Marijuana Descheduling Bill
Four 2020 Democratic presidential candidates have signed onto new legislation to federally deschedule marijuana—while a handful of other White House hopefuls are notably missing as original cosponsors.
The companion bills introduced on Monday by Senate Minority Leader Chuck Schumer (D-NY) and Rep. Hakeem Jeffries (D-NY) would remove cannabis from the Controlled Substances Act and use some tax revenue from marijuana sales to provide grants to socioeconomically disadvantaged individuals to participate in the legal industry.
It would also set aside money to support efforts to expunge past marijuana convictions.
Sens. Bernie Sanders (I-VT), Elizabeth Warren (D-MA) and Kirsten Gillibrand (D-NY) and Rep. Tulsi Gabbard (D-HI)—who are each seeking the Democratic presidential nomination—are cosponsoring the bills.
But Sens. Cory Booker (D-NJ), Amy Klobuchar (D-MN), Kamala Harris (D-CA) and Michael Bennet (D-CO) and Reps. Eric Swalwell (D-CA), Seth Moulton (D-MA) and Tim Ryan (D-OH) have so far declined to give the legislation their signature, despite their overall support for marijuana reform.
Bennet was an original cosponsor of a similar bill that Schumer filed during the 115th Congress.
The reasons he and other candidates decided against joining as original cosponsors of the new legislation are unclear, though some of them may end up adding their names at a later date.
For Booker, it’s possible that the senator doesn’t feel that the bill goes far enough in terms of promoting social equity—which is why he hasn’t supported separate cannabis reform legislation introduced this Congress.
Outside of the presidential candidates, Sens. Martin Heinrich (D-NM) and Tom Carper (D-DE) also cosponsored last year’s version but are not yet on the new proposal.
Meanwhile, lawmakers are moving ahead with plans to pass more modest cannabis reform legislation, including a bipartisan bill to give marijuana businesses access to banks that cleared the House Financial Services Committee in March.
Photo courtesy of Evan Johnson.
Two Federal Agencies Schedule Meetings To Discuss Marijuana-Related Issues
Two federal agencies recently announced that they will be holding meetings this summer to discuss public health and safety issues related to marijuana.
The Centers for Disease Control and Prevention (CDC) said in a notice published in the Federal Register last week that its Board of Scientific Counselors will convene on July 16 and 17 to tackle a wide variety of topics, including how to prevent the spread of infectious diseases and how to balance intramural and extramural research initiatives.
On the second day of the meeting, which will be open to the public, the panel of experts will also discuss the role of the CDC’s National Center for Injury Prevention and Control in “addressing public health concerns related to marijuana.”
Separately, on June 11 and 12, members of the Substance Abuse and Mental Health Services Administration’s Drug Testing Advisory Board will meet for a conversation about federal workplace drug testing policies. Part of that meeting will involve a discussion of “emerging issues surrounding marijuana legalization.”
While the Federal Register filing does not spell out which “emerging issues” will be specifically addressed during the first day’s public session, it also notes that the board will discuss the “impact of cannabis laws on drug testing and future direction” in a closed session on the second day of the meeting.
The federal discussion comes as marijuana reform advocates have stepped up efforts to end the employer practice of penalizing workers who test positive for THC metabolites.
In New York City, for example, a City Council measure prohibiting pre-employment drug testing for cannabis in specific industries and another barring such tests for people on probation were both enacted this month without the mayor’s signature.
While federal marijuana laws continue to strictly prohibit cannabis, the growing legalization movement has forced various agencies to address the issue. Officials from some federal divisions have observed in recent months that the scheduling status of marijuana under federal law has inhibited research into its public health benefits and risks.
In December, representatives from the Food and Drug Administration, Drug Enforcement Administration and National Institute on Drug Abuse were part of a workshop focusing on cannabis research.
U.S. government agencies have also used Federal Register notices to solicit the public’s help in identifying studies about the effects of cannabis on disorders such as Alzheimer’s disease.
Photo courtesy of Mike Latimer.