(Originally prepared for the 4th National Clinical Conference on Cannabis Therapeutics, Santa Barbara, California, April 6-8, 2006)
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 problem?
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 use.
2) Rescheduling will provide a regulatory framework that will attract investment capital to cannabis and cannabinoid drug development.
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 patients.
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 cannabis problem?
- 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 of drugs.)
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.