I find it very interesting when one bureaucracy is going to sue another bureaucracy.  Especially when one bureaucracy’s action interferes with the ability to generate some revenue by another bureaucracy. Could this be a “backhanded”  process of the DEA’s wish to yank pharmacy’s DEA licenses so that there are few pharmacies in the state that could buy/dispense controls?

Georgia Medical Cannabis Officials Weigh Response To DEA Threat Against Pharmacies, Including Possible Lawsuit

https://www.marijuanamoment.net/georgia-medical-cannabis-officials-weigh-response-to-dea-threat-against-pharmacies-including-possible-lawsuit/

The commission that oversees Georgia’s medical marijuana program held a special meeting on Wednesday to discuss recent letters from the Drug Enforcement Administration (DEA) warning pharmacies that dispensing THC under a state-authorized program could put their businesses at risk.

Officials at the meeting generally said the letters stand in the way of expanding medical marijuana access to patients, with one calling on supporters to contact Congress about the issue and another alluding to potential litigation the state may file against DEA over the dispute.

Georgia is the first state in the nation to pursue a plan to distribute medical marijuana through existing pharmacies that already dispense other drugs. Already about 120 independent pharmacies have applied to offer low-THC cannabis products.

But in its November 27 letter to pharmacies across the state, DEA said that federally registered pharmacies “may only dispense controlled substances in Schedules II-V of the Controlled Substances Act. Neither marijuana nor THC can lawfully be possessed, handled, or dispensed by any DEA-registered pharmacy.”

At Wednesday’s special meeting of the Georgia Access to Medical Cannabis Commission (GMCC), members said they’re still committed to prioritizing safe access for patients despite the federal threats.

Currently the state has only nine licensed dispensaries in operation, said GMCC Chair Sid Johnson. There are also 23 pharmacists approved to provide medical marijuana, whom Johnson described as “a critical part of ensuring access to patients, particularly in rural areas.”

“I want patients to know that we are well on our way to fully implementing the Hope Act,” Johnson said, referring to a 2019 law that expanded the state’s limited medical marijuana program, “and we will continue to pursue our mission of ensuring access to medical cannabis for all patients across Georgia.”

He added that “we support the work of the Board of Pharmacy, which licenses pharmacists to dispense medical cannabis.”

The commission’s general counsel, Jansen Head, said she believed the Board of Pharmacy has since paused its licensing of pharmacies to dispense medical cannabis. But behind the scenes, Head added, officials are discussing how to respond.

“I don’t think the state is quiet. I think right now we’re gathering information and seeing what’s the best way to move forward while also keeping in mind the interests of our patients and the industry,” she said. “I know that’s not super specific, but there are things kind of developing in response to the letter.”

Any legal action, she suggested, would need to come from the state attorney general’s office.

“We’re not the only key players in the program, and so it does require collaboration with our sister agencies,” she said. “And then obviously, any kind of action that we would take are things that we would do through the arms of the AG’s office, through the executive branch.”

One issue Head highlighted is a congressionally approved budget rider that bars the federal government from interfering with state-legal medical marijuana programs.

Specifically, it prohibits the Department of Justice (DOJ) from using its resources to prevent states “from—and I’ll quote—’implementing their own laws that authorize the distribution, possession or cultivation of medical marijuana,’” Head said at the meeting. “And that’s the program we have in Georgia.”

The budget rider, she added, limits federal law enforcement “from taking legal action against the states directly in order to prevent us from promulgating or enforcing our medical marijuana laws.”

Whatever the intent was with the DEA letters,” the lawyer continued, “more than half of our access points for medical relief—which is the pharmacies—they’re impacted and at risk of no longer making this medicine available to patients, as recommended by their physicians.”

While Head didn’t explicitly say the state was weighing a lawsuit to fend off the DEA warnings, she described a path the state could take to push back against the threats.

Commission member Bill Prather, a pharmacist himself, said he interpreted DEA’s correspondence as a shot across the bow.

“I no longer own a pharmacy or any part of a pharmacy,” Prather said. “If I did, I would take the letter from the DEA as, in my opinion, exactly what it is, which is a direct threat to pharmacies, saying, ‘If you dispense this product, we’ll pull your DEA permit.’”

Andrew Turnage, executive director of GMCC, said the conflict demonstrates “the need for federal government to update the laws and policies regarding the use of cannabis.”

“It’s a federal issue, so we don’t have the authority to intervene,” he said, “but we certainly want to encourage everyone to reach out to their members of Congress and make their wishes and concerns known about this issue.”

Marijuana Moment reached out to multiple members of Georgia’s U.S. House delegation for comment last week and this week, with little response.

“Cannabis could have some medicinal benefits, and we owe it to patients to research and test the drug for that purpose,” Rep. Buddy Carter (R-GA) told Marijuana Moment. “The DEA has made it clear that pharmacies dispensing certain THC products are in violation of federal law and that guidance should be taken seriously.”

On the Senate side, meanwhile, staff for Sen. Raphael Warnock (D), who recently confronted bankers in a committee hearing about the need for social equity in marijuana reform, did not respond to emails. Sen. Jon Ossoff’s (D) office declined to comment.

Georgia’s Board of Pharmacy has also not responded to Marijuana Moment’s requests for comment.

State officials recently presented the pharmacy plan at a meeting of the Cannabis Regulators Association, or CANNRA, and Turnage said it was “definitely an item of discussion.”

“The feedback that we received in that environment was simply this: ‘This is exactly the way that it should have been from the beginning. This model makes perfect sense,’” he recalled. “But they also expressed concern as it relates to finding out about the DEA’s letter.”

“A lot of states who are also medical states, they’re kind of eager to learn more about what Georgia will do,” added Head, the body’s general counsel. “They’re really looking at how Georgia is going to handle this tension.”

Head also said she was happy to hear support at the CANNRA meeting from regulators in other states who have “dealt with the DEA in different situations.”

“They really encouraged us to really try to see that through, to not be afraid of the challenges,” she said. “I think we had about seven or eight other states really putting themselves out there to support Georgia if if there’s some developments in response to the DEA letter. They’ve got attorneys, also attorneys general who just kind of offer themselves up as a resource.”

Brather, the physician, said that “It would really help us as far as distribution of the product if pharmacies could dispense it, because there is a pharmacy I believe in all but three or four counties in this state.”

“It will be a huge help to our patients, which are the main focus, if they could get their medication in a pharmacy,” he said.

Turnage, the commission’s executive director, agreed.

“There’s something really important about a licensed professional being between a regulated drug in a patient with a medical need,” he said. “And to the extent that we have been able to under the framework of our state’s law, the commission and the Board of Pharmacy have carried that vision into reality.”

“While our licensed dispensaries are certainly more than capable of providing access for patients in Georgia,” Turnage added, “they are limited in number by the statute, and therefore they’re not always within the immediate vicinity of where patients live.”

One member of the commission said he appreciated DEA as an agency, which he claimed “provides some value.”

“I believe that we really don’t know enough about THC to be using it safely,” said Bill Bornstein, a doctor and chief medical officer at Emory Healthcare. “That’s not to say I’m not supportive of what we’ve done in the state of Georgia, but there are a lot more questions that need to be answered.”

At the same time, Bornstein said similar DEA threats wouldn’t apply to physicians, who don’t technically prescribe marijuana to patients but instead merely certify that someone has a qualifying condition for the program.

Georgia’s Board of Pharmacy began accepting applications from independent pharmacies to dispense low-THC cannabis oil, which under state law can contain no more than 5 percent THC, in October. The goal was to improve access to medical marijuana among patients, who are otherwise restricted to just seven dispensaries that have opened in the state since April.

The Atlanta Journal-Constitution reported early that month that nearly 120 pharmacies had applied to the Board of Pharmacy to dispense marijuana products made by Botanical Sciences, one of the state’s two licensed producers. Pharmacies could also distribute medical cannabis from Trulieve, the state’s other licensed producer.

As of late October, at least three pharmacies had begun dispensing Botanical Sciences products, the company said in a press release. According to a map on the company’s website, more than 100 more are slated to open soon.

If sales of medical cannabis products went online in all locations, about 90 percent of Georgians would be within a 30-minute drive of a pharmacy selling marijuana, according to an Associated Press report. The state allowance applies only to independent pharmacies, not larger chains such as CVS and others.

DEA sent the warning letters to Georgia pharmacies amid the federal agency’s ongoing review of a recommendation by the Department of Health and Human Services (HHS) that marijuana be rescheduled under the Controlled Substances Act (CSA), reportedly to Schedule III. The recommendation was leaked in late August, and DEA has yet to publicly act on it.

While the Congressional Research Service (CRS) recently concluded that it was “likely” that DEA would follow the HHS recommendation based on past precedent, DEA reserves the right to disregard the health agency’s advice because it has final jurisdiction over the Controlled Substances Act (CSA).

In October, HHS first publicly revealed a one-page version of the rescheduling memo, though it was heavily redacted to remove key information. This past week, the government handed over another 252-page tranche of documents related to the review, again with the majority of information blocked out.

Broadly, the new documents outline new scientific information that’s come to light in recent years subsequent to an earlier denial of a rescheduling petition, which HHS suggests might now necessitate rescheduling marijuana.

“The current review is largely focused on modern scientific considerations on whether marijuana has a CAMU [currently accepted medical use] and on new epidemiological data related to the abuse of marijuana in the years since the 2015 HHS” evaluation of marijuana under the CSA’s eight-factor analysis.

HHS also notes that it “analyzed considerable data related to the abuse potential of marijuana,” but added that it’s a complicated consideration, “and no single test or assessment provides a complete characterization.”

Earlier this month, six Democratic governors wrote a letter to the Biden administration urging that rescheduling be completed by the end of the year. As DEA implied in its letter to the Georgia pharmacy, pharmacies would be permitted to dispense marijuana if it’s moved to Schedule III, although pharmaceutical products would first need to be approved by the Food and Drug Administration.

“Rescheduling cannabis aligns with a safe, regulated product that Americans can trust,” says the governors’ letter, which points to a poll that found 88 percent of Americans support legalization for medical or recreational use. “As governors, we might disagree about whether recreational cannabis legalization or even cannabis use is a net positive, but we agree that the cannabis industry is here to stay, the states have created strong regulations, and supporting the state-regulated marketplace is essential for the safety of the American people.”

Even if THC is moved to Schedule III, however, the Food and Drug Administration (FDA) would still need to approve marijuana-based drugs before they could be legally distributed at registered pharmacies like those in Georgia.

 

 

 

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