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Documents Show FDA’s Rationale Against Marijuana Rescheduling

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http://www.raps.org/Regulatory-Focus/News/2016/10/19/26037/FOIAd-Documents-Show-FDAs-Rationale-Against-Marijuana-Rescheduling/

FOIA’d Documents Show FDA’s Rationale Against Marijuana Rescheduling

Posted 19 October 2016By Michael Mezher

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In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA), the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana.

FDA’s recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August.

Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where medical marijuana is legal, marijuana use—even for medicinal purposes—remains illegal at the federal level under the Controlled Substances Act (CSA).

By denying the two petitions, DEA opted to keep marijuana controlled as a Schedule I drug, meaning that in the agency’s view it has “no currently accepted medical use” and a “high potential for abuse,” leaving it among the ranks of other Schedule I drugs such as heroin, ecstasy and LSD.

Pro-marijuana advocates are also quick to point out that a number of drugs commonly considered more dangerous than marijuana, such as cocaine, methamphetamine and opium, occupy the less strictly controlled Schedule II.

In response to the two petitions, DEA called on the US Department for Health and Human Services (HHS) to conduct an evaluation of available data on marijuana and make a recommendation as to whether or not it should be rescheduled.

According to a letter from then Acting FDA Commissioner Steven Ostroff, FDA and the National Institute on Drug Abuse (NIDA) conducted a broad review of marijuana, specifically looking into the drug’s potential for abuse, pharmacology, availability, as well as the scientific and medical literature on its uses in medicine.

Editor’s note: 17 US states currently allow the use of low-tetrahydrocannabinol (THC), high cannabidiol (CBD) oil for medical purposes under certain circumstances; but, as the FDA review and DEA decision do not consider marijuana constituents or derivatives, CBD is not discussed here. However, last week the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it considers products containing CBD to be medicines.

As a result of the review, both FDA and NIDA maintained their recommendation that marijuana remain a Schedule I drug.

“Since our 2006 scientific and medical evaluation and scheduling recommendation responding to a previous DEA petition, research with marijuana has progressed. However, more research should be conducted into marijuana’s effects, including potential medical uses for marijuana and its derivatives,” Ostroff said in the letter.

However, Ostroff went on to say that such studies must be designed to produce reliable scientific data. “For example, we recommend that studies need to focus on consistent administration and reproducible dosing of marijuana,” he said.

FDA Review

FDA’s review focused on assessing available data on marijuana against eight factors defined in 21 USC 811(c) for placing or removing a drug from scheduling:

  1. “Its actual or relative potential for abuse.
  2. Scientific evidence of its pharmacological effect, if known.
  3. The state of current scientific knowledge regarding the drug or other substance.
  4. Its history and current pattern of abuse.
  5. The scope, duration, and significance of abuse.
  6. What, if any, risk there is to the public health.
  7. Its psychic or physiological dependence liability.
  8. Whether the substance is an immediate precursor of a substance already controlled.”

In the report, FDA makes the argument that marijuana has a high potential for abuse based on data showing that roughly 18.9 million Americans used marijuana monthly in 2012, with more than a fifth of those meeting criteria for dependence or abuse.

The agency also points to data that shows marijuana accounted for more than a third of all illicit drug-related emergency department visits in 2011.

In one section of the report, FDA points to a number of studies in monkeys and rodents that demonstrate that the animals can be trained to self-administer cannabinoids in certain circumstances. These self-administration studies, FDA says, are “often useful in predicting rewarding effects in humans, and is indicative of abuse liability.”

Moving on to humans, FDA says that a number of common subjective responses to marijuana are “often associated with drug-seeking and drug-taking” behaviors:

Marijuana effects

FDA also refutes the argument that marijuana should be removed from Schedule I because an FDA-approved cannabinoid-containing product—Marinol, which contains delta9-THC—is currently in Schedule III.

FDA distinguishes Marinol from marijuana as the former has approved indications under a new drug application (NDA) and because of “major differences in formulation, availability, and usage between marijuana [and Marinol] contribute to their differing abuse potentials.”

Another reason, FDA adds, is because smoking marijuana causes more potent psychoactive effects than when the drug is taken orally. “The intense psychoactive drug effect achieved rapidly by smoking is generally considered to produce the effect desired by the abuser,” FDA writes. “This explains why abusers often prefer to administer certain drugs by inhalation, intravenously, or intranasally rather than orally.”

As for research into medical uses of marijuana, FDA looked at a number of “small clinical exploratory studies” published in the medical literature.

Specifically, FDA identified 11 studies conducted in the US and Canada between 1974 and 2013 that met its criteria (randomized, placebo-controlled, double-blinded trials that evaluated marijuana for a particular indication).

In each case, FDA says the studies were unable to prove efficacy “based on a number of limitations in their study design.”

FDA also says there isn’t enough consensus among “qualified experts” showing that marijuana is safe and effective.

However, FDA’s review also dispels a number of unsubstantiated claims related to marijuana.

Notably, FDA says it disagrees with the decades-old notion that marijuana is a “gateway drug.”

“Little evidence supports the hypothesis that initiation of marijuana use leads to an abuse disorder with other illicit substances,” FDA writes.

The agency also says there is no “causative link between marijuana use and the development of psychosis,” pointing to a number of large studies that find marijuana users do not have a higher incidence of psychosis.

Vice News, Report and other documents

Author: Cenedella.de

Philip J. Cenedella IV - The 2-continent Cannabis Consultant First and foremost, I am a Patient Advocate since 1977. I have also served as a Board of Director for the World Trade Center San Diego, as a Lead Consultant for Deutsche Telekom's Executive Board, Founded the Dayton Human Trafficking Accords and have been a C-Level Business Development Executive for over 3 decades. From California, now residing in Germany and providing professional business development services to firms from the USA and Europe. How I can help you: Business Development services including establishing Sales Channels, Joint-Venture Partnerships and Distribution Networks in Europe and North America. Call +1.888.206.3264 Skype: philip.j.cenedella eMail: phil@cenedella.de ...for a no-obligation initial discussion.

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