(Originally prepared for the 4th National Clinical Conference
on Cannabis Therapeutics, Santa Barbara, California, April
What is Rescheduling?
Under U.S. federal law cannabis is controlled as a Schedule
I substance and is only available for research purposes and
only under strict controls. Rescheduling is an administrative
process in which the government reviews recent scientific
research and decides if the regulatory status of a drug should
be changed. In this case, rescheduling refers to an
administrative law petition filed with the Drug Enforcement
Administration (DEA) by the Coalition
for Rescheduling Cannabis (CRC) in 2002. For information
on the administrative process and the standards of review:
See 21 USC 811 and 21 USC 812.
What are the requirements for rescheduling?
In a nutshell, Schedule I drugs have the highest potential
for abuse and have no accepted medical use. The purpose of
the rescheduling petition is to have the federal government
acknowledge that cannabis has an accepted medical use in the
United States and that its abuse potential is significantly
lower than Schedule I drugs such as heroin.
How will Rescheduling address the medical cannabis
The immediate results of rescheduling will be three fold.
1) Recognition of the medical use of cannabis provides a
legal basis for protecting patients from prosecution for
criminal offenses established to punish non-medical drug
2) Rescheduling will provide a regulatory framework that
will attract investment capital to cannabis and cannabinoid
3) Rescheduling will create a regulatory environment that
will allow states to implement the recommendation of the
Institute of Medicine to create single-subject research
programs as a short-term measure to provide cannabis to
How long will rescheduling take?
Based on previous efforts, federal rescheduling actions involving
marijuana should be expected to take 7 to 10 years to complete,
including judicial review in the federal courts.
The current rescheduling
petition was filed with the Drug Enforcement Administration
(DEA) in 2002 and was referred to the Department of Health
and Human Services (HHS) in 2004 for a complete medical and
scientific review. When the review is complete HHS will forward
it, along with their recommendations, back to DEA. After considering
any additional information they deem relevant, DEA will then
publish their proposed decision on the scheduling of medical
cannabis in the Federal Register and invite public comment.
Interested parties challenging issues of fact presented by
DEA can seek a hearing before an administrative law judge.
Disagreements over issues of law can be appealed to the federal
courts by interested parties with standing who suffer material
harm on account of DEA decision.
However, once the HHS review is complete the federal government
has the authority to expedite the rescheduling process. If,
for example, HHS completes their review in 2006 then medical
cannabis could be removed from schedule I and placed in a
schedule recognizing accepted medical use in 2007.
What else needs to be done?
Patients need legal protections at the state and local level
immediately. We need to understand that there are two separate
but equally important issues involving medical cannabis use.
The first is criminal liability, the second is legal access.
The difficulties in providing legal access must not delay
efforts to provide protections from criminal liability.
State and local innovation, though, does not address the national
problem. Indeed the only way to provide legal access to medical
cannabis is with a national policy. We need a national policy
to provide immediate medical access until such time that the
existing drug development can adapt itself to the opportunities
and challenges of cannabinoid drug development.
What are the other different approaches to the medical
- Medical Necessity Defense
- State Research Programs
- Federal Compassionate Use Program
- California Model – Proposition 215
- Patient/Caregiver exemption model
- Patient/Caregiver affirmative defense model
- Farr Amendment/State elective strategy
- Orphan product development model
- Non-profit product development model
- For-profit product development model
What do these plans have in common?
1) they all seek to provide access to cannabinoid drugs;
2) they are entrepreneurial;
3) they are all temporally insufficient (they take too long);
4) and/or they are spatially insufficient (they do not provide
a national solution);
5) and/or they are all professionally insufficient (they
are not compatible professional standards of practicing
medicine of regulating the manufacture and distribution
Why is rescheduling a solution to these problems?
Rescheduling provides an opportunity for innovation that is
consistent with existing professional and regulatory standards.
The only problem with the rescheduling approach is the lengthy
amount of time the process requires – however this problem
can be addressed through state and local level action to protect
medical cannabis patients from prosecution.
The medical cannabis reform movement is faced with the same
challenges as the rest of the non-profit sector. The problems
faced by the medical cannabis movement are administrative,
managerial, financial, and organizational. Public interest
work such as this is an exercise in social entrepreneurship,
the forging new combinations of goods and services out of
social capital and other resources. Social entrepreneurship,
though, requires a high degree of professionalism to succeed.
It is only through such professionalism that innovation can
prosper. The medical cannabis movement is characterized by
a high degree of innovation. Rescheduling provides a way for
the movement to succeed by providing a context that allows
professionals and all interested stakeholders to innovate
in a way that has a direct and profound impact on public policy.