The FDA Just Got A Truckload Of Marijuana Comments Delivered To Them

The FDA Just Got A Truckload Of Marijuana Comments Delivered To Them

Last month, the Food and Drug Administration (FDA) requested public input on the international classification of marijuana and other drugs. Well, ask and you shall receive.

More than 20,000 people submitted comments ahead of the Wednesday deadline. And about half of those were gathered and hand-delivered to FDA headquarters by NORML, which created an online tool to streamline comments.

That’s about how many comments the organization delivered in April, in response to a similar FDA open comment period on cannabis.

The organization posted a video of the new delivery on Facebook, so you can watch it for yourself below:

https://www.facebook.com/norml/videos/195700877994990/

“In just over two weeks, we received more than 10,000 comment submissions from our supporters,” NORML Political Associate Carly Wolf told Marijuana Moment. “It’s so important for everyday American citizens to speak up and participate at every opportunity because when it comes down to it, our communities are being directly impacted by the discriminatory and destructive policies our government has unjustly implemented.”

“The sooner these supposedly ‘fact-based’ bureaucracies acknowledge the actual realities of marijuana’s effects, widespread medical uses and very low potential for abuse, the sooner we will end the criminalization of cannabis.”

Another 10,591 comments were submitted online via the federal regulations.gov portal.

Altogether, the comments are aimed at informing the United States’s position on drug scheduling requirements under international treaties that prohibit member countries from legalizing cannabis. Marijuana is currently included in the most restrictive category under international treaties, similar to its placement in Schedule I under U.S. law.

The World Health Organization (WHO) is actively reviewing the global scheduling system to see if it should be amended. In August, WHO determined that one ingredient in cannabis, CBD, was a relatively safe and therapeutic substance that doesn’t deserve to be scheduledunder international treaties.

While the comments from this round varied somewhat in terms of how each individual framed their argument, the vast majority published so far seem to be supportive of either loosening or eliminating international restrictions on marijuana.

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

See the original article published on Marijuana Moment below:

The FDA Just Got A Truckload Of Marijuana Comments Delivered To Them

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

It’s not every day that the federal government requests public input on international marijuana laws, but that’s exactly what the Food and Drug Administration (FDA) did last week. And the comments are pouring in.

So far, the agency says it has received more than 2,100 comments—a small fraction of which have been published. The comments range from personal anecdotes about how cannabis has helped patients to arguments about the economic benefits of legalization. Others put the issue more bluntly:

“Just legalize it already.” —Anonymous

The comment period is fairly open-ended, so there’s not necessarily a “right” way to express your views. What the agency requested is input on the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of cannabis and several other substances.

The comments will be considered as the United States responds to the United Nations World Health Organization. That response will help inform the international group on “whether to recommend that certain international restrictions be placed on these drugs” or whether that should be reclassified under international drug treaties.

For reference, here are a few other comments to FDA that stand out:

“I am a 25-year old male working in finance in NYC, please legalize marijuana — it is one of the few answers to budget deficits across the nation in the form of billions in tax revenue, and it is a scientifically “safer” drug than both alcohol and nicotine, the latter two of which are currently legal and causing billions of dollars in healthcare related costs.”

“The benefits of Cannabis Plant and Resin far outweigh its health risks. All forms of THC and CBD should be made completely legal for medicinal and recreational use immediately, and taxed accordingly.”

“I am writing to voice my support for full cannabis descheduling. It is clear that the current policy is a failure in controlling a substance that is dramatically less harmful than currently legal products. This injustice to the American people has gone on for far too long. “

“Marijuana has been legalized for medical use in 31 states. Additionally, it is legal for recreational use in 9 states with more voting on it this mid-term election. Canada is also legalizing marijuana federally on October 17th. The United States needs to get its head out of the sand and take a more progressive approach to marijuana use and research.”

“I am a combat veteran of the Iraq war, and I am ASHAMED of the way that the United States Government is treating veterans like myself who know firsthand the positive effect that cannabis can have for people suffering from PTSD. I know that it has helped me. Stop standing in the way of our potential happiness.”

The FDA isn’t just asking about marijuana—there are 16 substances included in this comment period—but it’s clear that cannabis is the primary subject of interest, at least in the submissions that have been published so far. The comments overwhelmingly support de-scheduling or legalizing cannabis, with rare exceptions.

For example, one anonymous commenter who claimed to be representing a “major corporate client” lamented reportedly declining property values in a Massachusetts jurisdiction where a marijuana dispensary operates. The losses, the commenter claimed, amounted to more than $29 million.

Another reform critic who identified himself as Eric R. Eliason from Utah said he “took two puffs of a joint” in college and suffered academically.

“I usually get As in math but the next semester I got Fs in all my classes (except an A in tennis where I cheated). Marijuana impairs judgment and stays in your system for a very long time. Drugs are bad for you. We need critical thinkers for our economy.”

Eric R. Eliason is also the name of a U.S. House candidate in Utah, running as a United Utah Party member. The candidate denied having written the comment in a tweet, noting that he knows several other individuals with the same name.

“LOL. I’ve never had an F, never had a tennis class, and never had a toke,” Eliason wrote on Twitter. “Based on writing style, I would nix the professor and the gastro surgeon as well.”

For those who are supportive of changing international treaties to free up countries to set their own marijuana policies—but perhaps aren’t sure how to articulate their views to the FDA—NORML launched an online tool on Tuesday that offers editable, pre-written letters that the organization will submit to the FDA.

“In April, in response to a similar FDA request, NORML collected and hand-delivered over 10,000 comments to the agency calling on it to recommend a lifting of international restrictions criminalizing the plant,” the organization wrote.

“It is imperative that rational, evidence-based policies are what our policy makers review, and the FDA public comment period provides a terrific opportunity for citizens to make their voices heard,” NORML Political Director Justin Strekal told Marijuana Moment.

“Here at NORML, we made it easy with a pre-written letter with recent studies, which commenters can easily edit as they see fit to include additional context. In April, during the first round of public comment, over 60 percent of all submissions came from NORML members and we hope to continue to dominate the discussion in October.”

For those who want to submit comments to the FDA through the official government channel, Marijuana Policy Project general counsel Kate Bell shared some advice with Marijuana Moment.

“1. Submit something. Don’t worry about whether others might submit similar comments or make them in a more compelling fashion. The sheer volume of comments makes a statement.
2. Explain your expertise. It’s okay if you’re not a policy expert or medical researcher. For example, if you are a medical cannabis patient or you have a marijuana-related conviction on your record, let them know how marijuana’s current classification has personally affected you.
3. Make sure you address the questions that are being asked. In this case, review the issues that the WHO is considering, which are listed in the FDA’s request for comment.”

Whatever your individual stance is, and whatever method you choose to submit your comment, there’s one date to keep in mind: October 31 is the deadline to make your voice heard.

See the original article published on Marijuana Moment below:

Thousands Respond To FDA’s Marijuana Rescheduling Comment Request

Where Supreme Court Nominee Brett Kavanaugh Stands On Marijuana And Drug Policy

Where Supreme Court Nominee Brett Kavanaugh Stands On Marijuana And Drug Policy

President Donald Trump’s Supreme Court pick, Brett Kavanaugh, will shape the country’s legal system for decades to come if he is confirmed by the Senate. But how would the federal judge rule in cases dealing with marijuana legalization and drug policy reform?

When it comes to cannabis and the right of states to set their own laws, it’s really anybody’s guess at this point. Kavanaugh doesn’t appear to have weighed in on the issue specifically, but it’s possible he’ll be asked about his views during confirmation hearings by pro-legalization Judiciary Committee members like Sens. Cory Booker (D-NJ) or Kamala Harris (D-CA).

That said, a brief overview of the nominee’s judicial record reveals someone who routinely defers to the regulatory authority of the Food and Drug Administration (FDA), which has for decades refused to change marijuana’s restrictive status under federal law. For example, Kavanaugh sided with the majority in a 2007 case before the U.S. Court of Appeals for the District of Columbia Circuit, which determined that terminally ill patients don’t have a constitutional right to access drugs that haven’t received FDA approval.

That could set up an interesting debate if there are any legal challenges to a new “right to try” law that Trump signed in May. The policy allows seriously ill patients to access unapproved drugs— and based on the criteria, cannabis may qualify.

Kavanaugh also upheld the authority of the FDA in a 2013 case, STAT News reported. He argued that the federal agency’s procedure for approving or denying expedited approval of medical devices should be respected.

“A court is ill-equipped to second-guess that kind of agency scientific judgment.”

A 2012 case concerning drug testing—for which Kavanaugh wrote a dissenting opinion—is also revealing. The federal judge argued that mandating drug testing of government employees at specialized residential schools for at-risk youth doesn’t violate the Fourth Amendment.

“A residential school program for at-risk youth who have a history of drug problems can turn south quickly if the schools do not maintain some level of discipline,” he wrote. “To maintain discipline, the schools must ensure that the employees who work there do not themselves become part of the problem. That is especially true when, as here, the employees are one of the few possible conduits for drugs to enter the schools.”

Kavanaugh said that because the drug testing program is “narrowly targeted” and the government “has a strong and indeed compelling interest in maintaining a drug-free workforce,” the mandate doesn’t amount to a violation of the constitutional right against unreasonable searches and seizures.

Though these cases don’t provide an especially comprehensive window into the SCOTUS nominee’s views on marijuana specifically, they do appear to reflect a pattern: Kavanaugh puts his faith in the FDA, which has denied that marijuana has any proven medical benefits, and his interpretation of the limitations of the Fourth Amendment seems to stand in contrast to drug policy reform advocates.

Analysis: GOP Congress Has Blocked Dozens Of Marijuana Amendments

See the original article published on Marijuana Moment below:

Where Supreme Court Nominee Brett Kavanaugh Stands On Marijuana And Drug Policy

FDA Rejects Anti-Legalization Pharma Co’s Cannabis Drug Request

FDA Rejects Anti-Legalization Pharma Co’s Cannabis Drug Request

The same drug company that donated $500,000 to a campaign to defeat marijuana legalization in its home state of Arizona in 2016 is now actively fighting to deter competition against its own synthetic THC product. Efforts to extend its exclusive right to manufacture the drug have resulted in a back-and-forth with a federal agency that ultimately resulted in the pharma firm’s request being summarily rejected.

Insys Therapeutics, a pharmaceutical company that came under fire over its anti-legalization election spending, is also known for producing potent opioids and a drug called Syndros, a synthesized THC product containing dronabinol that’s similar to Marinol, except that it’s a liquid preparation rather than a pill.

To many advocates, the company’s anti-legalization spending reeked of conflicts of interest. Was Insys worried that legal weed in Arizona represented a threat to its bottom line? The company essentially admitted as much in 2007, writing in a disclosure statement to the Securities and Exchange Commission (SEC) that “the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected” if marijuana or synthetic cannabinoids were legalized.

Now, according to publicly available documents, Insys is engaging in another type of battle. It wants extended exclusivity over its oral dronabinol product. And in October 2017, the company asked the Food and Drug Administration (FDA) to decline applications from competitors seeking to produce generic versions of Syndros.

Insys has already sued two such drug companies, Par Pharmaceuticals and Alkem Laboratories, after learning that they had submitted Abbreviated New Drug Applications (ANDA)—the first step in the process of gaining approval for generic versions of existing drugs—which “triggered a 30-month stay” in one case, Insys senior vice president of regulatory affairs Stephen Sherman noted in a October 2017 citizen petition to the FDA.

[scribd id=377304774 key=key-4UC6MtuQ6FNNzwL1szNH mode=scroll]

In light of disclosures that drugmakers were submitting FDA applications to develop generic versions that referenced Syndros, which might eventually provide patients with cheaper alternatives, Insys appealed to the FDA.

Its request was in two-parts: 1) It asked the FDA to decline to “receive or approve” any ANDA applications that didn’t establish “in vivo bioequivalence” to its drug, and 2) that any ANDA applications for its drug “include fed and fasted state bioequivalence studies.”

In essence, Insys argued that its drug was too complex to be replicated by generic competitors that didn’t first conduct extensive testing demonstrating its biochemical likeness.

In a letter made public earlier this month, the FDA flatly denied the company’s petition. The government agency disputed the claims Insys included in its letter and clarified how the ANDA approval process works

[scribd id=377304971 key=key-ZbD3KBd1C1PEjm0ecT3X mode=scroll]

Robin Feldman, professor of law and director of the Institute for Innovation Law at UC Hastings College of the Law in San Francisco, literally wrote the book on all the different ways that mainstream pharmaceutical companies try to subvert generic competition.

She told Marijuana Moment that the bioequivalence testing Insys requested was already required in any ANDA application, so it was kind of like “petitioning the FDA to say ‘we insist that you do what it is that we all know you’re going to do.’ And with that, you get five months of delay.” In a phone interview, Feldman couldn’t help but laugh as she was read another section of the drug company’s citizen petition. That section says:

“Insys notes that it is currently awaiting an FDA exclusivity determination with respect to SYNDROS and expects to receive three years of exclusivity based on the submission of new clinical studies essential to approval.”

“Companies pile these exclusivities on one after another to keep generic competitors off the market as long as possible,” Feldman said. “So the reason I laughed is what you are seeing is a multipronged effort by the brand company to stave off generic entry as long as possible.”

“They’re using a variety of techniques: citizen petition, additional regulatory exclusivity, and adding these on. Each delay may be of limited time, but they may be extremely valuable—and together, they can add up to significant costs to the consumer,” she said.

In her book and published studies, Feldman reported that approximately 80 percent of citizen petitions, like the one submitted by Insys, were denied by the FDA. Submitting a citizen petition is often a delay tactic for drug companies hoping to maintain exclusivity over their brands, because “[d]elaying generic competition for as little as six months can be worth half a billion dollars in sales for a blockbuster drug,” she wrote in an op-ed for STAT.

False or misleading citizen petitions from drugmakers are so common, in fact, that Feldman created a beta “alert system” for users to submit and detect suspect petitions. When she ran Insys’s October 2017 petition through the system, it “came back with red flags,” she said.

Insys Therapeutics did not respond to requests for comment by the time of publication. This story will be updated if the company sends comment.

See the original article published on Marijuana Moment here:

FDA Rejects Anti-Legalization Pharma Co’s Cannabis Drug Request

 

Here’s Where You Can Tell Trump To Support Marijuana Rescheduling

Here’s Where You Can Tell Trump To Support Marijuana Rescheduling

As Marijuana Moment first reported last week, the Trump administration is asking Americans for input on whether marijuana should be reclassified under international law.

On Monday, the Food and Drug Administration officially began accepting online commentsabout the topic.

Feds Want Input On Marijuana Reclassification

Here’s what you need to know:

Currently, under both American law and global drug treaties to which the U.S. is a party, marijuana sits in the most restrictive category of Schedule I. Here at home, that means cannabis is not available for formal prescriptions and research on its effects is significantly restricted. Internationally, it means that countries signed onto drug treaties are not supposed to legalize cannabis.

But the United Nations World Health Organization is now beginning its first-ever review of marijuana’s classification, and is inviting input from member nations like the U.S.

And the Trump administration is accepting public comments that it will use to inform the the U.S.’s position on the issue before it weighs in on the global scheduling process.

Starting on Monday, and through April 23, interested persons can easily submit comments online about why the U.S. should support reclassifying marijuana.

Doing so takes only a few minutes.

Comments can run up to 5,000 characters, and people can also attach supporting documentation if they like. Commenters can choose whether or not to include their contact information along with their submissions.

If the WHO does move to support the rescheduling of cannabis under international agreements, it will likely add to pressure to change marijuana’s status under the laws of individual countries like the U.S.

See the original article published on Marijuana Moment below:

Here’s Where You Can Tell Trump To Support Marijuana Rescheduling

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