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FDA Teaches Marijuana Growers And Researchers How To Protect Trade Secrets From Competitors

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The Food and Drug Administration (FDA) is hosting a meeting next week to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant.

The webinar, which is taking place on Wednesday, will encourage cannabis-based drug developers and growers to use “drug master files,” or DMFs, which “are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.”

In essence, a DMF is a secure method of transmitting private documents that could help supplement various proposals to the agency such as Investigational New Drug Applications (INDs) without risking competitors getting their hands on trade secrets.

Participants in the event “will learn how DMFs might be able to help address their concerns related to the disclosure of potentially proprietary information,” FDA said in a notice.

Further, the meeting will overview draft guidance FDA released in July that covers researching cannabis for drug development purposes. That document, which was released after being approved by the White House, explains the basics of conducting federally authorized research to create cannabinoid-based drugs such as where researchers are allowed to obtain marijuana and the importance of demonstrating the ability to “consistently manufacture a quality product.”

FDA’s Cassandra Taylor from the Office of Pharmaceutical Quality will lead the meeting and also talk about the agency’s role in the “regulation of cannabis products.”

“I think this sends the dual message that the FDA is becoming more willing, perhaps even committed, to allowing research to move forward and is beginning to recognize its role in regulating cannabis products,” Morgan Fox, director of media relations at the National Cannabis Industry Association, told Marijuana Moment. “It seems to also indicate a realization that there is great interest in developing proprietary methods and products going forward and a willingness treating interested parties like other actors in the food and drug approval space.”

“Overall, I think it should be taken as a positive sign that the organization is taking this issue more seriously and anticipating major changes in federal law regarding cannabis in the relatively near future,” he said.

Separately, FDA recently submitted draft guidance on CBD enforcement to the White House Office of Management and Budget—a long-anticipated move that comes after the federal legalization of hemp and its derivatives.

The agency was mandated under appropriations legislation enacted late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”

FDA has been using enforcement discretion for CBD in the years since hemp’s federal legalization.

The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.

In July FDA also submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.

Also that month, a congressional spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”

The agency is also actively looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.

Third GOP Congressman Pledges To Vote For Marijuana Legalization Bill On House Floor This Month

Photo courtesy of Philip Steffan.

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Democrats Remove Marijuana Research Bill From House Floor Schedule After Briefly Listing Possible Vote

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On Friday afternoon, a bipartisan bill to promote marijuana research was included in a list of legislation that was “scheduled for consideration” on the House floor next week. But hours later, it was removed.

“It was just an error,” a spokesperson for House Majority Leader Steny Hoyer (D-MD) told Marijuana Moment. “It’s not scheduled for next week.”

This is the second cannabis-related scheduling complication to occur within the House this month. The chamber’s leadership had previously announced plans to hold a vote on a comprehensive federal cannabis legalization bill this week, but that action was postponed following pushback from certain centrist Democratic members. 

The Medical Marijuana Research Act that was mistakenly included in the list of bills to be taken up next week cleared the House Energy and Commerce Committee earlier this month in a voice vote. The crux of the proposal is to streamline studies, and one notable mechanism through which it would do that is to let researchers obtain cannabis from dispensaries in legal states—a significant departure from current policy that restricts scientists to using marijuana grown under federal authorization.

That could resolve an issue identified by researchers and lawmakers, who complain that marijuana produced at the only existing authorized facility at the University of Mississippi is difficult to access and is chemically closer to hemp than cannabis available on the commercial market.

It’s not clear whether that provision will be a sticking point for members who oppose broader marijuana reform if it does eventually get a floor vote. As initially listed on the House’s weekly calendar, the bill would have been considered under a process known as suspension of the rules, under which it could advance on an expedited basis with no amendments allowed and which requires at least a two-thirds majority to pass.

The legislation would also establish a simplified registration process for researchers interested in studying cannabis, in part by reducing approval wait times, minimizing costly security requirements and eliminating additional layers of protocol review.

As it was originally drafted, the bill would have made it so researchers could access marijuana from additional federally approved private manufacturers. But an amendment in the nature of a substitute was approved in committee, also via a voice vote, that included the component expanding access to state-legal dispensaries.

In July, the House approved separate legislation that also called for letting researchers study marijuana purchased from businesses in state-legal markets instead of only letting them use government-grown cannabis. The intent of that provision, tucked into a 2,000-plus-page infrastructure bill, was to allow the interstate distribution of such products even to scientists in jurisdictions that have not yet legalized marijuana.

The revised research-focused proposal that the House is poised take up next week also stipulates that nothing about the legislation precludes the U.S. Department of Health and Human Services (HHS) secretary from enforcing Food and Drug Administration restrictions on the method of administration of marijuana, the dosage or number of patients involved in approved studies.

The bill would also make it so there would be no limit on the number of entities that can be registered to cultivate marijuana for research purposes. Additionally, it would require HHS to submit a report to Congress within five years after enactment to overview the results of federal cannabis studies and recommend whether they warrant marijuana’s rescheduling under federal law.

While the floor announcement would have represented a positive development for advocates, there’s still frustration over the postponement of a vote on the federal descheduling bill—the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act. Certain centrist Democrats reportedly convinced leadership to delay the action, citing concerns about the optics of advancing cannabis reform without first passing another round of coronavirus relief.

The research legislation is being led by the unlikely duo of pro-legalization Rep. Earl Blumenauer (D-OR) and prohibitionist Rep. Andy Harris (R-MD).

During an Energy and Commerce Subcommittee on Health hearing in January—which was requested by four GOP lawmakers last year—federal health and drug officials, including from DEA, acknowledged that the current supply of cannabis for research purposes is inadequate and that scientists should be able to access a wider range of marijuana products.

DEA said four years ago that it would be taking steps to expand the number of federally authorized cannabis manufacturers, but it has not yet acted on applications.

Last year, scientists sued the agency, alleging that it had deliberately delayed approving additional marijuana manufacturers for research purposes despite its earlier pledge.

A court mandated that DEA take steps to make good on its promise, and that case was dropped after DEA provided a status update.

In March, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party.

The scientists behind the original case filed another suit against DEA, claiming that the agency used a “secret” document to justify its delay of approving manufacturer applications.

That was born out when the Justice Department Office of Legal Counsel document was released in April as part of a settlement in the case, revealing, among other things, that the agency feels that its current licensing structure for cannabis cultivation has been in violation of international treaties for decades.

But the committee-approved bill states that international treaty obligations “shall not be construed to prohibit, or impose additional restrictions upon, research involving marijuana, or the manufacture, distribution, or dispensing of marijuana, that is conducted in accordance with the Controlled Substances Act, this Act, and the amendments made by this Act.”

The legislation has drawn support from a broad array of organizations on both sides of the legalization debate, including Smart Approaches to Marijuana, American Psychological Association, Marijuana Policy Project and American Academy of Neurology.

This story has been updated to reflect that the cannabis research bill will not receive a floor vote next week and was mistakenly included in the House schedule, seemingly due to a clerical error.

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Mexican Cabinet Member Accepts Gifted Marijuana Plant As Lawmakers Prepare Legalization Vote

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Marijuana is becoming something of a staple in the Mexican Congress, and not just when it comes to reform bills being considered. Actual cannabis products are regularly being exchanged, displayed and planted in and around legislative chambers as lawmakers work to legalize the plant.

On Wednesday, a top administration official was gifted a marijuana plant by senator, and she said she’d be making it a part of her personal garden.

Interior Ministry Secretary Olga SĂĄnchez Cordero said that by the time she plants the cannabis gift from Sen. Emilio Álvarez Icaza, she’ll be “fervently hoping that the law [to legalize cannabis] is already passed,” referring to reform legislation that the legislature has been working on the past couple years.

“The medicinal use of marijuana has been a revelation for the world, and second because hemp is industrially interesting from clothes, energy, paper, construction materials, stronger than any other construction material,” she said, according to a translation. “In other words, there is enormous potential with hemp and also the recreational use of marijuana, respecting the principle of the autonomy of the will and the free development of the person.”

Last year, a different lawmaker gave the SĂĄnchez Cordero a marijuana joint on the floor of the Chamber of Deputies.

“I bring you a gift as a reminder of that proposal you made at the beginning, because that goes to be the way to help us build peace. Let’s regulate the use of drugs,” Deputy Ana LucĂ­a Riojas MartĂ­nez said at the time.

Cannabis made another appearance in the legislature last month, when Sen. Jesusa RodrĂ­guez of the ruling Morena party decorated her desk with a marijuana plant.

Drug policy reform advocates have also been cultivating hundreds of marijuana plants in front of the Senate, putting pressure on legislators to make good on their pledge to advance legalization.

President Andrés Manuel López Obrador recently said that marijuana reform legislation will advance in the new session.

A legalization bill was approved by several committees earlier this year, but the reform effort has been stalled due to the coronavirus pandemic. The nation’s Supreme Court—which deemed the country’s prohibition on personal possession and cultivation unconstitutional in 2018—is currently giving lawmakers until December 15 to enact the policy change.

The legalization bill that’s set to advance this coming session was revised during a joint meeting of the Justice, Health, Legislative Studies and Public Safety Committees in March.

The proposal would allow adults 18 and older to possess and cultivate marijuana for personal use. Individuals could grow up to 20 registered plants as long as the total yield doesn’t exceed 480 grams per year. Medical patients could apply to cultivate more than 20 plants, however.

Personal possession would be capped at 28 grams, but possession of up to 200 grams would be decriminalized.

The Mexican Institute of Regulation and Control of Cannabis, a decentralized body established under the measure, would be established and responsible for regulating the market and issuing licenses for marijuana businesses.

The bill proposes a 12 percent tax on cannabis sales, with some revenue going toward a substance misuse treatment fund.

Public consumption would be permissible, except in spaces designated as 100 percent smoke-free. Hemp and CBD would be exempt from regulations that apply to THC products.

An earlier version of the legislation was approved by Senate committees last year ahead of the court’s previous October deadline.

Sen. Julio Ramón Menchaca Salazar, also of the Morena party, said in April that while legislators must still resolve certain disagreements about the legislation, legalizing cannabis could fill treasury coffers at a time when the economy is recovering from the pandemic.

While advocates are eager to enact reform, they’ve also raised several concerns with the legislation as drafted, particularly as it relates to restorative justice.

Zara Snapp, a legalization activist with the Instituto RIA and the coalition #RegulacionPorLaPaz, told Marijuana Moment on Friday that while it’s “concerning” that committees haven’t yet scheduled time to take the legalization bill back up, she’s had conversations with senators from all political parties and “they all tell me this will happen this legislative session.”

“We’re going to take them at their word that they will be approving this in the next two to three months,” she said.

Vermont Democratic Party Platform Calls For Decriminalizing Drugs And Legalizing Marijuana Sales

Photo courtesy of Twitter/EmilioAlvarezI.

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Vermont Democratic Party Platform Calls For Decriminalizing Drugs And Legalizing Marijuana Sales

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The Vermont Democratic Party formally adopted a platform this month that calls for bold drug policy reforms, including legalizing marijuana sales, promoting equity in the cannabis industry and decriminalizing possession of all currently illicit substances.

During a virtual meeting on September 12, about 100 local delegates from across the state approved the platform. Beside marijuana legalization and drug decriminalization, the party further called for a process to automate expungements and reassess sentencing guidelines more broadly.

All this came together as legislators worked to send the governor a cannabis tax-and-regulate bill and separate legislation that would provide automatic record clearing for prior marijuana convictions.

The party released the final language of its positions this week. Here’s how the drug policy-related planks were written:

-Adopt an approach to the possession and misuse of drugs that is motivated solely by the principles of public health and harm reduction, rather than punishing undesirable private behavior, while avoiding the criminal justice system altogether.

-Ensure that cannabis is appropriately regulated and taxed in a manner that rights the historic wrongs of the War on Drugs and that recognizes the disproportionate impact prohibition has had on minority communities.

-Expand access to expungement, including by enacting a system to automatically expunge criminal records, so that those who have repaid their debt to society can make a fresh start.

-Re-examine existing prison sentences in light of our current knowledge of how systemic bias has led to disparate outcomes based on race and socio-economic status, and give State’s Attorneys greater authority to take a second look at and reduce existing sentences where these biases are found, and otherwise are in the interest in justice.

“This platform reflects a continuing shift in attitudes among Vermont Democrats when it comes to drug policy,” Dave Silberman, a pro bono attorney and reform advocate who led the drafting of the platform’s criminal justice provisions, told Marijuana Moment. “As a party, we’ve fully recognized that the War on Drugs has completely failed to reduce problematic drug use, and in fact fuels the racial biases we see in policing today, all without contributing to public safety.”

“Even a few years ago, these statements would have been controversial, but today they are the consensus view,” Silberman, who is running for the elected office of high bailiff in Addison County, said. “I’m excited to work with Democratic elected officials in 2021 and beyond to turn these principles into law and policy.”

The Vermont Republican Party didn’t respond to Marijuana Moment’s request for reaction to Democrats’ drug policy positions by press time.

Legalizing marijuana sales in Vermont has been a priority for activists since the governor signed legislation in 2018 allowing adults to possess up to one ounce of cannabis and cultivate up to two plants.

After both chambers advanced the marijuana commerce bill earlier this session, it was sent to a bicameral conference committee to resolve differences. Those negotiations resulted in a finalized bill this month, which the House and Senate then approved, putting it on its way to the governor’s desk.

While Scott hasn’t said whether he will put his signature on S. 54, he noted last week that he’s been impressed with how the legislative process unfolded for the measure and would take that into account.

The expungements bill that also cleared the legislature this month would allow records to be cleared systematically and also people to possess and grow more cannabis without the threat of jail time than is currently allowed.

Outside Vermont, the Oregon Democratic Party this week formally endorsed statewide initiatives to legalize psilocybin mushrooms for therapeutic purposes and decriminalize possession of all currently illicit drugs while investing in substance misuse treatment.

Read the Vermont Democratic Party’s platform below: 

VDP 2020 Platform by Marijuana Moment

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