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Defying Congress, Jeff Sessions Keeps Blocking Medical Marijuana Research

Two years after accepting applications, the DEA has yet to grant licenses to growers.

JONATHAN ERNST/REUTERS/NewscomJONATHAN ERNST/REUTERS/NewscomIt's been almost two years since the Drug Enforcement Administration (DEA) began accepting applications for new growers of research cannabis, and two dozen applicants are still in regulatory limbo.

Since the DEA announced in August 2016 that it would end the federal monopoly on producing cannabis for scientific research in the United States, growers, investors, researchers, applicants, and even members of Congress have sought to understand why a relatively simple licensing review process has stretched on for nearly two years. The answer is pretty straightforward: Attorney General Jeff Sessions, for reasons he has not publicly disclosed, decided to intervene in a process that has historically not involved the attorney general in order to stop the DEA from issuing licenses to growers.

While the Controlled Substances Act gives the attorney general regulatory authority over scheduled drugs, that authority has historically been delegated to the DEA, which is part of the Justice Department. The DEA has a whole division, in fact, dedicated to "investigat[ing] the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs."

Members of Congress are not happy with Sessions' obstruction of the licensing process. In April, Sens. Orrin Hatch (R–Utah) and Kamala Harris (D–Calif.) sent the attorney general a letter in which they asked him to provide the Senate with a timeline for processing applications from potential manufacturers of research marijuana. They also asked the DOJ to update applicants on the review process. Both actions, Hatch and Harris suggested, should be completed by May 15, 2018. Not only did the DOJ miss that deadline, but it doesn't seem interested in playing catch-up.

Four license applicants I interviewed in late June told me they've received no official updates from either the DEA or the DOJ in months. Applicants who have spoken to congressional offices working on this issue say their contacts are equally frustrated by Sessions' obstruction of the DEA's licensing process.

(Reason obtained the identities of the 26 initial applicants through a Freedom of Information Act request to the DEA. Reason is not identifying which applicants provided information for this story so as not to jeopardize their chances of approval. )

"No 'formal' communication for months," one applicant told me by email. "They do answer questions I've asked, although on a limited basis."

"No formal communication," another told me. "Hoping to hear more soon."

"Just silence," a third applicant told me over email.

The Hatch-Harris letter captures both the widespread support for studying cannabis and the disproportionate power Sessions has to maintain the status quo. "Expanded research has been called for by President Trump's Surgeon General, the Secretary of Veterans Affairs, the FDA, the CDC, the National Highway Safety Administration, the National Institute of Health, the National Cancer Institute, the National Academies of Sciences, and the National Institute on Drug Abuse," the senators wrote. "In order to facilitate such research, scientists and lawmakers must have timely guidance on whether, when, and how these manufacturers' applications will be resolved."

The rapid pace of marijuana legalization at the state level, meanwhile, might seem to lessen the need for federally licensed growers of research cannabis. Can't researchers just use the myriad cannabis products available in the 30 states that allow recreational or medical use? They cannot.

Researchers who want to test cannabis products in humans must comply with federal regulations governing the handling of Schedule I controlled substances. Those regulations require researchers who would like to use domestically produced marijuana to obtain their material from a federally licensed grower. For decades now, there has been only one such grower: Mahmoud ElSohly at the University of Mississippi, who operates under a contract with the National Institute on Drug Abuse (NIDA). The hundreds of researchers who are licensed by the federal government to study marijuana in the U.S. must use material obtained from NIDA, despite credible concerns about quality control and the agency's ability to provide material that reflects the diversity of products available to consumers in medical and recreational dispensaries across the country.

No other field of drug research or development requires that all pharmaceutical companies and academic institutions that would like to source their materials domestically get them from one person chosen by the federal government. To see the impact on the U.S. drug industry, one need look no further than the U.K., which produced Epidiolex, the first marijuana-derived drug to ever be approved by the Food and Drug Administration.

Could GW Pharmaceuticals, the maker of Epidiolex, have brought its drug to market if its research had used cannabis grown at the University of Mississippi? Stephen Schultz, the company's vice president of investor relations, wouldn't speculate. He did say, however, that the U.K.'s cannabis regulations are essential to the company's drug development strategy. "We develop medicines that have a very specific cannabinoid profile," Schultz said. "So it is very important that we be in complete control of creating our medicines, from growing to extracting."

What's more, it won't be possible to get FDA approval for a cannabis-derived medicine made in the United States until new manufacturers are approved, since the material used in Phase III clinical trials must be identical to the material used in the medicine. In other words, NIDA marijuana cannot be used in Phase III trials.

In August 2016, it seemed like the U.S. might finally allow a market for research cannabis. That month, the DEA, which for years had resisted attempts to create such a market, announced that it would begin accepting applications for additional licenses to manufacture research marijuana. "Although no drug product made from marijuana has yet been shown to be safe and effective," the notice in the Federal Register said, the DEA "fully supports expanding research into the potential medical utility of marijuana and its chemical constituents."

Some two dozen entrepreneurs and companies submitted lengthy applications in the months that followed that announcement. Many submitted additional information at the DEA's request. Two applicants told me they'd raised millions in funding, and several others said they'd made intellectual property arrangements with cannabis growers and researchers overseas. Plots of land were scouted and buildings were leased.

But enthusiasm quickly gave way to anxiety after Sessions was confirmed as attorney general in February 2017. That August, anxiety turned to dread when The Washington Post reported that Acting DEA Administrator Chuck Rosenstein had resigned after butting heads with Sessions over research cannabis. Rosenstein was reportedly in favor of approving new licenses, but Sessions brought the review to a screeching halt.

The Washington Post story eventually made its way to Hatch, who asked Sessions at a hearing in October 2017 why the DOJ had yet to license new growers of cannabis for pharmaceutical research. During their brief exchange, Sessions told Hatch it would be "healthy to have some more competition in the supply" of research marijuana, but the DOJ was not going to approve all 26 applicants. I contacted Hatch's office twice for comment but received no response.

Sessions suggested that the DEA lacked the capacity to supervise even a handful of additional cannabis manufacturers. That claim sounds spurious considering that the DEA routinely approves applications to manufacture Schedule I and II substances other than marijuana. The agency approved eight such manufacturing applications in June 2018, seven in May 2018, eight in April 2018, and three in February 2018. (One applicant familiar with the DEA's licensing process told me the cost of supervising additional license holders is probably marginal.)

Senators questioned the attorney general again in April 2018. At that hearing, Sessions came up with another excuse for not allowing the DEA to move forward. This time, he claimed approving additional marijuana growers might violate a United Nations treaty signed by the U.S. This claim is almost certainly not true even under the most literal and conservative reading of that treaty.

One more deadline looms. Hatch and Harris would like to see Sessions act on all outstanding applications, either approving or rejecting them, by August 11, 2018, the two-year anniversary of the DEA's announcement in the Federal Register. By comparison, it took the DOJ less than six months to process the controlled substance manufacturing applications it approved in June, one of which was for making synthetic marijuana.

If Sessions blows the August deadline, he won't just be smiting a crop of would-be cannabis entrepenuers. He will be standing in the way of medical progress and punishing patients and their families in the process.

Photo Credit: JONATHAN ERNST/REUTERS/Newscom

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  • Citizen X||

    Attorney General Jeff Sessions, for reasons he has not publicly disclosed, decided to intervene in a process that has historically not involved the attorney general in order to stop the DEA from issuing licenses to growers.

    Seriously, fuck that guy.

  • Elias Fakaname||

    Sessions has time for this? Unless the guy is rounding up progressive de ocrats in record numbers and prosecuting them, he has time for nothing else.

    There should be at least a dozen special prosecutors, each more special than the last, investigating democrat wrongdoing. Which is mostly low hanging if these LEGO,e would just do their jobs.

  • AD-RtR/OS!||

    If he hadn't been forced to recuse himself from the Trump-Russia investigation, he'd have no time to fuck around with pot.
    Having been hoist on your own petard, what say you now?

  • perlchpr||

    It would be a complete tragedy if he happened to have a spontaneous quadruple anyeursm.

  • Echo Chamber||

    Ignorance is bliss

  • Longtobefree||

    Actually
    "Where ignorance is bliss, 'tis folly to be wise."

    Which explains a lot of college campuses.

  • StackOfCoins||

    If Trump fired Sessions, I think at this point, I'd honestly admire the guy.

    For all Trump's faults, he's done some great things, and kicking this geezer to the curb would win him major brownie points.

  • Shirley Knott||

    We're going to have to confiscate those brownies sir.

  • Elias Fakaname||

    That would make Rosenstein acting AG. So this won't happen until Rosenstein is gone.

  • Randy Marsh||

    He's the one that put him in there in the first place, I don't know why that deserves admiration. It's not like it wasn't known that he was terrible.

  • Diane Reynolds (Paul.)||

    When an attorney general successfully defies congress, you've got a problem.

  • Citizen X||

    Can the problem be blamed on Trump? If not, good luck getting it out there.

  • Robert||

    it was a favor for a favor: Sessions for Trump, therefore Trump for Sessions. But you'd think that'd be contingent on good behavior.

  • AD-RtR/OS!||

    Quite a bit of foolishness originates in Congress, and gets ignored for the good, and bad, of the country.

  • Jason Dawes the Elder||

    Defied Congress? No. He ignored a letter from Kamala Harris.

  • Jerryskids||

    Attorney General Jeff Sessions, for reasons he has not publicly disclosed, decided to intervene in a process that has historically not involved the attorney general in order to stop the DEA from issuing licenses to growers.

    "For reasons he has not publicly disclosed." He's been pretty open about how much he hates the devil weed, I think we can all put two and two together. Has Hillary Clinton ever publicly disclosed whether or not she voted for Donald Trump? Has anybody ever asked her to?

  • Hugh Akston||

    What in god's name is he holding in in that picture?

  • Diane Reynolds (Paul.)||

    A pair of dice. He's a playa.

  • Citizen X||

    Wings and legs he tore from living songbirds. It's the only way he can get off.

  • StackOfCoins||

    Heart pills.

  • SQRLSY One||

    It's his brains AND his conscience! They are so tiny, you can't see them, and he's afraid that they'll drift away in the wind, if he doesn't hold tight!

  • Longtobefree||

    I thought he kept them in the lower left hand drawer of his desk; along with his scruples and professional pride.

  • Agammamon||

    and the bottle of the cheapest scotch in the liquor store that is on the route between his office and home.

  • Aloysious||

    His wife let him have his testicles back. But only for a moment.

  • This Machine Chips Fascists||

    You've never seen evil spells cast before?

  • gaoxiaen||

    Nothing that a pint of prune juice won't cure.

  • Longtobefree||

    "Researchers who want to test cannabis products in humans must comply with federal regulations governing the handling of Schedule I controlled substances."

    So given the fact that cannabis has already been proven to have medicinal uses, isn't it illegal for Jeffy to keep it on schedule 1? Why doesn't the hate Sessions crowd in congress hold him in contempt?

  • Zeb||

    Because they are stupid assholes and they suck.

  • Wizard4169||

    That all depends on your definition of "proven". And prohibitionists love their little Catch-22: marijuana is dangerous because it hasn't been studied, but you can't study it because it's dangerous.

  • This Machine Chips Fascists||

    Alt text: Rage Against The Machine RÜLZ!

  • Jerryskids||

    Alt alt text: So I'm down on my knees in the Oval Office and Trump's standing there in front of me, but the Viagra hasn't kicked in yet, so I says to him, I says, "Just think of Pootie-Poot, bare-chested, riding a horse..." and boom.

  • perlchpr||

    s/horse/bear/

  • PaulTheBeav||

    Appointing Sessions is the worst thing Trump has ever done.

  • JuanQPublic||

    Agreed wholeheartedly.

  • Elias Fakaname||

    At this point I think even Trump believe that.

  • Bender B. Rodriguez||

    Christ, what an asshole.

  • Truthteller1||

    This little troll needs to be kicked to the curb. He's an embarrassment.

  • kynodog||

    Oh Magoo, you've done it again!

  • JuanQPublic||

    Now that swampy Scott Pruitt is done, time to push for cutting out the dead wood at the DOJ and bring it into the 21st century. Take care, Jeff Sessions.

  • Robert||

    Time for Trump to intervene.

  • Rockabilly||

    Man, look at that picture of Sessions at top with his fist all bunched up.

    He looks angry and constipated.

    He could use a marijuana enema and a two girl massage.

  • Jason Dawes the Elder||

    If Congress wants to change policy, I believe the proper means is legislation, not stray letters to the AG.

  • VinniUSMC||

    the Controlled Substances Act gives the attorney general regulatory authority over scheduled drugs

    Here's a novel idea, change this. Congress has the ability to write Sessions, and the office of AG, completely out of the equation, no? Who is at fault here?

  • mpercy||

    Congress could pass a law removing cannabis from the Schedule 1 drugs. Congress could pass a law making cannabis legal for medical use. Congress could pass a law making cannabis legal for recreational use.

    Congress has done none of those things, leaving the current law in place, which law specifies that the AG has regulatory authority over scheduled drugs. Much like Obamacare left 99% or or of the implementation to the HHS secretary. The fact that Trump's guy is being a dick over it is a problem only because Congress won't change the status quo.

    Congress should stop writing laws that abdicate huge swaths of implementation details and regulatory discretion to the executive, then complaining that the current executive isn't doing it right. Obama governed largely via executive fiats, and Trump is rolling those back at a furious pace. The next Democrat will roll them back into place in a regulatory yo-yo game.

  • William Clark||

    Prohibition of marijuana is a premise built on a tissue of lies. Our new laws save hundreds of lives every year, on our highways alone. In the thirteen states that decriminalized marijuana between 1990 and 2009, traffic fatalities have dropped by nearly nine percent more than the national average, while sales of beer went flat by five percent. Marijuana turns out to be a 'gateway' out of alcohol and opiate addictions.

    No one has ever died from an overdose of marijuana. It's the most benign 'substance' in history, a nerve-protectant that actually encourages brain-cell growth. It also has tumor-shrinking, anti-carcinogenic properties, as confirmed by a study at UCLA.

    Why in the world would churches object to its proximity? Some Detroit pastors have not done their homework. Their flocks have been misled. Marijuana is "cannabis" in Latin, and "kanah bosm" in the old Hebrew scrolls, quite literally the Biblical Tree of Life, used by early Christians to treat everything from skin diseases to deep pain and despair.

    Don't want it in your neighborhood? Maybe you're not the Christian you thought you were.

    Me? I'm appalled at the number of 'Christian' politicians, prosecutors, and police who pose on church steps or kneeling in prayer on their campaign trails cannot or will not face the scientific or the historical truths about cannabis, Medicinal Herb Number One, safe and effective for thousands of years, and celebrated as sacraments by most of the world's major religions.

  • MSimon||

    Sounds like you have read:

    Hebrew Etymology

  • OzarkAggie||

    Now is the perfect time for a few Republican senators to insist on Sessions' resignation before voting to approve the next SCOTUS nominee.

    5 should do it.

  • macsnafu||

    Who is going to hold Sessions accountable?

  • J.D. Bradley||

    I can't think of anyone in the world that needs to get high more than this asshole.

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