Government
Bipartisan Senate Bill Would Give ‘Right to Try’ Protection to Psilocybin and MDMA
Sen. Cory Booker of New Jersey and Sen. Rand Paul of Kentucky have introduced bipartisan legislation to extend Right to Try protection to drugs that have completed a Phase 1 clinical trial, including psilocybin and MDMA.
Democratic Senator Cory Booker of New Jersey and Senator Rand Paul, a Republican from Kentucky, introduced bipartisan legislation on Wednesday to extend federal Right to Try protection to the psychedelic drugs psilocybin and MDMA. Under the bill, titled the Right to Try Clarification Act, restrictions of the federal Controlled Substances Act would not apply to Schedule I Drugs for which a Phase 1 clinical trial has been completed. The new provisions would apply to doctors and patients with life-threatening medical conditions using Schedule 1 controlled substances under the federal Right to Try Act.
“As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” Paul said in a statement about the legislation from Booker’s office. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”
The Right to Try Act allows patients who have been diagnosed with life-threatening diseases or conditions for which traditional therapies have not been effective to use certain treatments that have not yet been approved by the U.S. Food and Drug Administration. In most cases, a drug is eligible for Right to Try use after a Phase 1 clinical trial has been completed for that drug but before the drug is approved or licensed by the FDA for any use. Under the provisions of the Right to Try law, states have the option to permit or prohibit Right to Try use under state law.
The senators noted that two drugs, MDMA and psilocybin, show promise as treatment for a variety of mental health conditions, including depression, anxiety, and PTSD. The success and safety of the drugs exhibited in Phase 1 and Phase 2 clinical trials has been so encouraging that the FDA has classified both substances as “breakthrough therapies,” indicating that they show a substantial improvement over currently approved therapies.
“Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” said Booker. “Unfortunately, many eligible patients who urgently need care do not currently have access to these promising therapies. This legislation will put the patient first and help ensure access to life-changing and life-saving drugs.”
Companion Measure To Be Introduced in the House
A bipartisan duo of members of the House of Representatives who support federal cannabis policy have already signed on to support Booker and Paul’s bill and will introduce companion legislation in the House. Democratic Representative Earl Blumenauer of Oregon, who has long supported reforming the nation’s cannabis laws, and Representative Nancy Mace, a first-term Republican who introduced a bill to legalize cannabis last year, expressed their support for the change to Right to Try legislation.
“Oregon has a long legacy of ensuring that end-of-life patients have access to the full spectrum of treatment options to alleviate their condition and improve their quality of life. Patients and doctors deserve to discuss treatments—including psilocybin—that researchers find provide immediate and sustained relief from pain, anxiety, and depression for people battling terminal illness,” Blumenauer said. “Federal restrictions have obstructed access to end-of-life care for too long, this legislation will change that and ensure that all patients have the Right to Try. I appreciate Senator Booker’s leadership, it is timely and important.”
“Advances in science and technology are often made when we think outside the box and try new things,” said Mace. “This legislation gives patients the power to choose alternative options like psilocybin or MDMA when facing a life-threatening condition. We know these chemicals have the potential to save lives, and today is an important step forward in medical progress. I want to thank Senators Booker and Paul for their bipartisan work to bring these exciting new options into the mainstream medical world.”
The Right to Try Clarification Act was introduced in the Senate only one day before Booker, Senate Majority Leader Chuck Schumer of New York and Democratic Senator Ron Wyden of Oregon introduced a long-anticipated bill to legalize cannabis at the federal level. Shane Pennington, an attorney with the law firm Vicente Sederberg, said that he is “happy to see Congress paying attention to psychedelics issues, particularly those that affect the veteran community. Vets shouldn’t have to go to other countries to access therapies that evidence has shown to be safe and likely effective.”
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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