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?