efying Congress, Jeff Sessions Keeps Blocking Medical Marijuana Research

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From reason.com

Defying Congress, Jeff Sessions Keeps Blocking Medical Marijuana Research
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Us Attorney General Jefferson Beauregard Sessions

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

Mike Riggs| Jul. 5, 2018

It'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 political name'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.

Read More Here
https://reason.com/blog/2018/07/05/jeff-sessions-continues-to-sabotage-much
 
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I am sorry. I seem to have misplaced my "Oh I am surprised" face.
 
Hey, it's his job. Poor guy. I almost feel sorry for him. His future is not bright. LOL

As cannabis gains ground, he will be made more of a buffoon and the press will berate and belittle him until a 'scandal' forces him to 'retire' in humility. Statements he makes will be taken out of context and he will be made to blame for every 'anti-pot' statement that ever came out of Washington.

This is how Washington tosses a lamb to the wolves. Watch this guy in the next 2 years and tell me it's not almost a pity. LOL

Good news for us but, it's not going to be pretty for him and his family. Like Rosie says, everyone is fighting a battle. He is no exception. His life is about to turn to shit. LOL
 
Jefferson Sessions has never been shy about expressing how he feels about cannabis.
 
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Sessions doesn't have the balls to say, that he is not going to process any applications.
 
No way do I have (or will I ever have) even the slightest amount of pity for this evil little elf. He is a close-minded, racist, evil caricature of a man. ANYTHING he gets, he is most likely deserving of.
 
If U look real close at that pic U can see it right between his eye !-- 666 !--The Mark of the Beast !-- He just a minion !
 
And, that's EXACTLY why Washington and the TV news is going to make a total spectacle of him..... because it's what everyone wants to see.
 
I for one can't wait to see it !--An Administration with it's on News network and everything else is fake news ?-- I know a little about history and I seen that before !-- Pretty sure people ain't gonna stand silently by and let that happen again ! --
 
How can he be this misinformed about pot? Oh, nevermind, i forgot who he works for, misinformed is our new way.
 
I don't know gang, I think he's kind of cute. He reminds me of that cute little Italian mouse that was always on Ed Sullivan...

Topo Gigio

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I always thot he was called Po po.

I can not feel sorry for him either Goddess. I sincerely hope they all get what they deserve. Even a micron less would make me smile.

 
I never seen that mouse cartoon before !-- All I know is Session just an illegitimate racist rat bastid Nazi like his boss !-- To still support that pretty much shows your true colors !
 
Keef, you need to chill dude. You have way too much hate in you.
 

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