Saturday, September 27, 2014

The Myths of Rescheduling


The Myths of Rescheduling

 

Talk of rescheduling marijuana under the Controlled Substances Act has been rampant lately, especially in light of recent statements by Attorney-General Holder and then by his resignation.  Most agree that the placement of marijuana in Schedule I, along with heroin and various psychedelics, which prevents it from being prescribed or distributed through commercial and pharmaceutical channels, is incorrect and should be changed.  But quick action is unlikely.  Many of the shortcuts to rescheduling bandied about today will not work.

Three myths are being proposed, but they are all faulty.  But before dispelling those myths, an understanding of the legal framework for scheduling is necessary.  My earlier post, “MJ, DEA, and APA” outlines the legal and procedural requirement for that process.

The first myth to be dispelled is that the Attorney-General may directly reschedule a drug with the stroke of his pen.  While the DEA is administratively with the Justice Department, it functions under its own statutory authority and the law gives the DEA Administrator sole authority to schedule drugs.  While the A-G may request (or possibly even order) the DEA to initiate a rescheduling process, he may not usurp the Administrator’s authority and dictate what the determination will be.  If the A-G disagrees with the Administrator’s actions, he may ask the President to fire that Administrator and appoint a new one (subject to Senatorial consent) more agreeable to him, or he might restrict the agency’s funding in future budgets.  The Attorney-General’s control over the scheduling process is only indirect.

The second myth is that the Department of Health and Human Services can reschedule marijuana through its own actions.  Although current regulations (not statutes: an important distinction) require the Secretary of HHS to provide a report on the “medical value” of marijuana to the DEA in any proceeding to reschedule, this requirement is much less than it appears for two reasons.  First, while HHS is required to submit the report to the DEA, it is not conclusive or binding on the Administrator; he need only give it due consideration.  The hearing is still governed by the substantial evidence rule (see the earlier posting noted) and the Administrator need only base his finding on substantial evidence, not a preponderance.  So long as the Administrator has even a single credible (based on his determination) witness that marijuana has no substantial medical use, then a court must uphold his finding of continuing Schedule I placement.

The HHS report has another, more serious flaw.  HHS is required to report on the “medical value” of marijuana, but the DEA is constitutionally barred from deciding medical value.  For about ninety years – since 1925 – the Supreme Court has held that the federal government cannot regulate the practice of medicine, which includes determining what is or is not a medicine (most recently in 2008).  Few realize that the FDA does not regulate medicine; it only approves labels for drugs; and if a drug is sold without that approved label, the sale is deceptive and misleading and the seller can be punished civilly and criminally.  Likewise, the DEA cannot determine if a drug is effective (or has medical “value”).  The statute limits the DEA into determining whether the drug has “substantial medical use”.  In other words, it can only ask what doctors and patients, in fact, do with marijuana.  A medical “value” report would be irrelevant to that determination.

The third myth – that rescheduling will significantly contribute to marijuana law reform – is partially true.  Rescheduling would make marijuana more available to researchers and could lead to improvement in therapies and the development of marijuana-based medicines, but it would do little, if anything, to improve patient access.  Remember, morphine, Oxycodone, cocaine, and amphetamines are all Schedule II drugs; but they all have FDA labelling approval – all of which pre-date the CSA.  Without FDA marketing approval, normal drug distribution channels would still be closed[1].  Federal criminal laws against distribution or possession are based on the identity of the drug, not its scheduling (cocaine and methamphetamine are the best examples).

Rescheduling would do little or nothing to correct the real costs of Prohibition – the fostering of a violent black market, corrupt and abusive law enforcement, over-imprisonment.  Forty years of effort (the first rescheduling petition was filed in 1972) have failed to overcome the almost overwhelming legal obstacles to rescheduling, and have diverted effort and resources from more direct efforts at reform.  At best rescheduling is a palliative, at worst, it hinders effective reform efforts.

The route to reforming marijuana laws lies through the source of that disastrous law.  Reform must come through Congress and our efforts must focus on bringing that institution to act in the public good.  



[1] I pose a question to those more knowledgeable about FDA law: If marijuana were moved from Schedule I, could a practitioner or clinic with its own production facility directly dispense marijuana to its patients even without an approved NDA?

5 comments:

  1. Removing marijuana from schedule I does not address the issue of which schedule, if any, marijuana should be transferred to. The term "rescheduling" assumes marijuana will be transferred to another schedule, which is by no means a certainty.

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  2. Since marijuana fits the definition of drug under the CSA, it will have to be scheduled unless the statute is changed by congress. My own sense is that Sched. V most nearly fits.

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  3. My only goal is not schedule 1. It's too hard to predict what will happen after that, so I'll set a new goal when I see what happens.

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  4. Enjoyed reading through this, very good stuff,
    thanks . "A man may learn wisdom even from a foe."
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