A key U.S. Senate committee says that marijuana’s current federal classification blocks scientific research on its effects—something that legalization advocates have long argued.
“The Committee is concerned that restrictions associated with Schedule 1 of the Controlled Substance Act effectively limit the amount and type of research that can be conducted on certain Schedule 1 drugs, especially marijuana or its component chemicals and certain synthetic drugs,” the Senate Appropriations Committee wrote in a new report under the headline, “Barriers to Research.”
“At a time when we need as much information as possible about these drugs, we should be lowering regulatory and other barriers to conducting this research.”
Schedule I is the most restrictive category under federal law, and is supposed to be reserved for drugs with a high potential for abuse and no medical value. Researchers wishing to study substances classified there must overcome procedural hurdles that don’t exist for other drugs.
The Senate panel is directing the National Institute on Drug Abuse to “provide a short report on the barriers to research that result from the classification of drugs and compounds as Schedule 1 substances.”
The directive is part of a report attached to a bill to fund the Departments of Labor and Health and Human Services for Fiscal Year 2019, approved by the committee last week.
This isn’t the first time the panel highlighted the problems federal law poses for cannabis researchers. The senators included similar language in last year’s version of the annual report for the health agency funding bill.
Curiously, the language slamming Schedule I’s research roadblocks has been consistently requested by a group whose membership list contains some of the nation’s leading anti-legalization advocates.
But while the Senate committee has approved a number of marijuana reform amendments over time — including measures last month to protect state medical cannabis laws from Justice Department interference and to increase military veterans’ access to medical marijuana — it also recently blocked a proposal to protect banks that work with marijuana businesses from advancing.
And, it also included questionable comments about cannabis and driving, the involvement of Indian tribes in the marijuana industry and cultivation of cannabis on public lands in recent reports attached to other funding bills.
In the new report attached to the health agency bill, the committee also seemed to express concerns about the growing number of states that are legalizing marijuana and the increasing availability of higher potency cannabis products.
“The Committee is concerned with the rapidly changing landscape regarding the recreational use of marijuana–the effects that the drug can have on brain development; addiction; the long-term health effects in both youth and older individuals,” the senators wrote. “The Committee directs NIH to coordinate a multi-Institute approach to increase research related to the effect of increasing delta-9-tetrahydrocannabinol levels on the human body as well as the effect of various delta-tetrahydrocannabinol levels on cognitive abilities that are required to, for example, operate motor vehicles.”
And, they want federal researchers to resume tests on cannabis seized by law enforcement.
“Without dedicated funding for this activity, the number of analyzed seized samples has plummeted, meaning that available data is no longer current or robust,” the report says. “The Committee believes that such research, along with analysis of marijuana and marijuana-derived products sold commercially in dispensaries or online, is essential for informing substance misuse and addiction prevention efforts, public health policy, and law enforcement tactics across the Federal Government.”
“The Committee continues to direct NIDA to coordinate efforts with the DEA and other law enforcement agencies to monitor Schedule I marijuana and marijuana-derived products.”
But despite the seeming concern about the effect of state legalization, the panel’s criticism of Schedule I’s roadblocks to marijuana research provides more momentum to the effort to reclassify cannabis under federal law.
South Carolina Lawmakers Approve Medical Marijuana Bill In Subcommittee Vote
A South Carolina Senate subcommittee voted Wednesday to advance a bill that would legalize access to medical marijuana. The legislation, known as the Compassionate Care Act, now moves to the full Senate Medical Affairs panel for discussion and a possible vote.
The subcommittee vote of 5 to 1 came after lawmakers approved several amendments to the bill. Some of those changes include narrowing the list of medical conditions that would qualify a patient to legally use medical cannabis, banning certain workers from being able to access the treatment and requiring physicians to have specific qualifications before being able to recommend marijuana.
“I want to thank the law enforcement officials, business leaders and physicians who worked with members of this subcommittee to ensure that this medical cannabis bill reflects the will of the overwhelming majority of South Carolinians … but to also draw a bright line against the recreational use of cannabis,” said Sen. Tom Davis, the bill’s author.
Advocates say they’re happy the bill is moving, but are expressing concerns about the changes that were adopted. Judy Ghanem, the executive director of patient advocacy group Compassionate SC, said she worries the bill will ultimately limit how many people will actually be able to access cannabis for their medical needs.
“The main concern that we have is, will enough doctors actually be recommending [medical cannabis] and will enough patients be able to get the medicine,” she told Marijuana Moment in a phone interview.
The original text of the bill authorized primary care physicians to recommend cannabis to their patients with debilitating medical conditions. “There might not be as many specialists that are willing to recommend as there would be regular physicians,” Ghanem said.
“Concessions have to be made, and we understand that, but from a logistics standpoint, we need to have a law that’s workable,” she continued. “We hope that it’s not narrowed any more than it is now. We’re still going to be happy that patients will get the medicine, but that doesn’t mean we’re not going to do everything we can to increase the number of patients that can have access.”
Also on Wednesday, a group of faith leaders held a news conference at the State House to show their support for legalization.
The bill still faces an uphill battle, as opponents from the State Law Enforcement Division (SLED), S.C. Sheriffs’ Association and S.C. Medical Association have all said they won’t get behind the legislation without the Food and Drug Administration’s stamp of approval on medical marijuana.
“Never before have we determined what medicine is by popular vote or legislation,” SLED Maj. Frank O’Neal told the Post & Courier.
This is the fourth year the Compassionate Care Act has been introduced in the South Carolina legislature. Last year, it was approved by both the Senate Medical Affairs Committee and the House Medical, Military, Public and Municipal Affairs (3M) Committee, but it did not receive floor consideration in either chamber before the session ended.
A January poll found that a majority of South Carolinians support legalizing medical marijuana.
Photo courtesy of Chris Wallis // Side Pocket Images.
FDA Chief Warns CBD Rulemaking Could Take Years Without Congressional Action
The outgoing head of the Food and Drug Administration (FDA) suggested on Tuesday that it would take several years for the agency to come up with rules around allowing hemp-derived cannabidiol (CBD) in food products—unless Congress steps in.
At a Brookings Institution event, FDA Commissioner Scott Gottlieb recognized that there’s strong interest among the cannabis industry and lawmakers in developing a regulatory framework through which CBD from hemp could be extracted, sold and introduced into the food supply. The problem is that “CBD didn’t previously exist in the food supply, and it exists as a drug under the statute.”
“It can’t just be put into the food supply,” he said, arguing that current law only allows the FDA to “contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.”
That rulemaking process can take two to three years for conventional products, and so because CBD is “more complex”—due to its association with marijuana—and has already been approved by the FDA as a drug to treat epilepsy (in the form of Epidiolex), it could theoretically take much longer to develop those regulations.
“We’ve never done this before,” Gottlieb said. “It would be a highly novel rulemaking process.”
In the meantime, the FDA is putting together a “high-level work group” that will work to identify “some potential legislative pathways might be to create a framework for allowing CBD into the food supply.”
Gottlieb said he expects the group to release some recommendations by the summer, as Business Insider first reported.
The commissioner said the work group will be formally announced within the next week and would involve a public meeting to solicit comments from stakeholders.
While Congress might have intended to permit the marketing of hemp-derived CBD through the 2018 Farm Bill, the commissioner indicated that additional legislation that specifically addresses CBD regulations would be necessary to allow the ingredient in the food supply. He said there’s precedent for such actions, citing legislation around human growth hormone and fish oil.
“I think you need to come up with a framework that defines concentration levels, where you would create some kind of cut off, and that would be up to the agency to do,” he said. “Congress would obviously give directions to the agency to do that.”
“CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe—I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value. But this is a process that the agency would have to work through. I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD.”
Gottlieb made similar comments in response to questions from members of a House Appropriations subcommittee last month, where he announced that the agency would hold a public meeting in April to gather input from stakeholders on CBD regulation.
In the new comments, the commissioner also added that he felt the Drug Enforcement Administration (DEA) would have to “formally de-schedule” hemp-derived CBD before moving forward with regulatory changes, in spite of the fact that the agriculture legislation shifted regulatory responsibility for the crop and its derivatives from the Justice Department to the U.S. Department of Agriculture.
“I think the prevailing view is that the plain language of the statute [of the Farm Bill] intended for that, but I’m not sure that DEA has done that yet,” he said. “But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”
The desire for clarity around CBD’s legality post-Farm Bill passage has been widespread. For example, the U.S. Postal Service issued an advisory earlier this month spelling out rules for mailing hemp-derived CBD. Representatives from state agriculture departments also heard talk about “alternative approaches” to regulating the compound at a conference last month.
In his remarks at Brookings, Gottlieb announced that the CBD work group would be co-chaired by Amy Abernethy, FDA’s principal deputy commissioner, and Lowell Shiller, the agency’s acting associate commissioner for policy.
In the meantime, it is clear that lawmakers want FDA to move on the issue.
“Every meeting I go into on Capitol Hill, almost every meeting, I get asked about this,” Gottlieb said.
Photo courtesy of YouTube/Brookings Institution.
Beto O’Rourke Says Prosecute Pharma Execs And Legalize Marijuana
The federal government should end the prohibition of marijuana and prosecute pharmaceutical executives who recklessly marketed addictive opioid painkillers, Beto O’Rourke argued at a rally in New Hampshire on Tuesday.
The 2020 Democratic presidential candidate received enthusiastic applause in response to the pitch from the crowd in the early primary state, which has been hard hit by the opioid crisis.
“We’re going to acknowledge an incredibly warped system of justice in this country,” the former congressman said, singling out Purdue Pharma, the maker of OxyContin, over its products’ role in the addiction problem.
“The vast majority of those who are addicted today began with a legal prescription,” he said. “Those executives understood the addictive properties of what they sold and did not share that with the public, and not a single one of them has done a single day in jail.”
“Yet, we have the largest prison population on the face of the planet, disproportionately comprised of people of color, far too many there for possession of a substance that is legal in most states of this country, marijuana.”
Watch O’Rourke’s marijuana and drug policy comments, about 20:00 into the video below:
The candidate expanded on the unfairness, noting that rates of cannabis use are roughly the same for different races but “only some are more likely than others to be arrested, to serve time, to upon release be forced to check a box” rendering them ineligible for student loans and making it more difficult to secure employment.
“We need real criminal justice reform,” he said. “We need to end the prohibition of marijuana, expunge the arrest records for everyone arrested for possession of something that’s legal in so many other places, and make sure that we have a full prosecution and accountability for those who are responsible for the deaths of tens of thousands of Americans in this country.”
"O’Rourke spoke about reforming the justice system, ending prohibition on marijuana charges, ensuring universal health care & making those implicated in the opioids crisis accountable. He received the biggest cheers for promising action on climate change" https://t.co/UCRvn5Ef2c
— Beto O'Rourke (@BetoORourke) March 20, 2019
There were signs that drug reform would be a main feature of O’Rourke’s campaign in the weeks leading up to his announcement, and he’s quickly confirmed that suspicion on the trail. He sent out an email blast about marijuana reform before declaring his bid and he discussed ending cannabis prohibition on the day of his announcement.
But contrasting the unchecked malfeasance of the pharmaceutical industry with the aggressive enforcement of cannabis laws represents an evolution in O’Rourke’s messaging on the issue.
It’s not dissimilar to a talking point often heard at rallies for Sen. Bernie Sanders (I-VT), who frequently talks about the injustice of failing to prosecute Wall Street executives for their role in the 2008 financial crisis while locking up individuals for non-violent marijuana offenses.
Sen. Kirsten Gillibrand (D-NY), another 2020 Democratic presidential candidate, has also criticized the pharmaceutical industry for misleading prescribers about the risks of potent opioid painkillers while opposing marijuana reform.
“To them it’s competition for chronic pain, and that’s outrageous because we don’t have the crisis in people who take marijuana for chronic pain having overdose issues,” she said, adding that she doesn’t see cannabis as a gateway to opioids. Rather, “the opioid industry and the drug companies that manufacture it, some of them in particular, are just trying to sell more drugs that addict patients and addict people across this country.”
She said last month that the U.S. criminal justice system “puts people in prison for smoking marijuana while allowing corporations like Purdue Pharma, who are responsible for the opioid-related deaths of thousands of people, to walk away scot-free with their coffers full.”
Photo courtesy of Facebook/Circa.