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?

Tuesday, September 16, 2014

XXIst Amendment: Model for Reform?

XXIst Amendment: Model for Reform?

Section 1.
The eighteenth article of amendment to the Constitution of the United States is hereby repealed.

Section 2.
The transportation or importation into any State, Territory, or Possession of the United States for delivery or use therein of intoxicating liquors, in violation of the laws thereof, is hereby prohibited.

Section 3.
This article shall be inoperative unless it shall have been ratified as an amendment to the Constitution by conventions in the several States, as provided in the Constitution, within seven years from the date of the submission hereof to the States by the Congress

Passed by Congress February 20, 1933. Ratified December 5, 1933.

In 1933 the American people removed the Prohibition of alcohol that they had imposed by the XVIIIth Amendment to the Constitution only fourteen years earlier in 1919.  They did so by ratifying the XXIst Amendment.  Today as the nation struggles to get out from under the burden of drug Prohibition (especially that of marijuana) can that amendment provide a model for accomplishing this?

First, the good news.  Alcohol Prohibition was created by a constitutional amendment, requiring another amendment to undo it.  Other the other hand, drug Prohibition is only statutory and can be removed by the simple legislative process.

 Second, the model uses broad policy strokes, avoiding contentious legislative fights over the details and fine print of reform.  It avoids locking into place regulations that are either destructively rigorous or so loose as to invite pandemonium.  Its focus on federalism and local choices allows for experimentation to allow the evolution of the most appropriate controls.

The Amendment has only two operative sentences.  The first simply repeals the Prohibition Amendment.  The second, drawing on the Commerce Clause of the Constitution, makes transportation of alcohol across a state border in violation of that state’s laws a federal crime.  (This interstate transport provision is similar to the old Mann Act, making the interstate transport of a woman across a state line for “immoral purposes” a federal crime, or the presumption of interstate movement to enable FBI jurisdiction in kidnapping cases.)  These two simple provisions, together with an excise tax on alcohol have provided sufficient regulation of alcohol for over eighty years.

Would the same two-step process -- first, remove direct federal control, but provide federal assistance to states whose laws differ from their neighbors -- be enough to end marijuana[1] Prohibition as well?   Although the general plan would be effective, the broad scope of the federal anti-drug laws add some complexities.

The second part would be easy enough.  A simple statute would make a federal crime of transporting drugs into or through the territory of a state if possession, transportation, distribution of that drug is a violation of that state’s law.  An exemption should probably be created to allow travelers with medical marijuana permissions under home state laws immunity for carrying small amounts for personal use.  The only problem would be to determine the penalty level.  The greatly reduced level of enforcement would justify closing down the policing part of the DEA and assigning the remainder to ATFE, which has over eighty years of enforcing similar alcohol provisions.

The first part – repealing the current federal anti-marijuana laws -- is more problematic for two reasons. First, marijuana Prohibition has metastasized throughout the federal code.  Marijuana possession or sale is penalized, even if not directly criminalized, in laws affecting eligibility for public housing, both student aid and aids and grants to educational institutions, banking regulations, the tax code, employment drug testing, and many others.  Close research of the federal code will be necessary to insure that the repeal language is broad enough to include all of these civil, indirect, or implicit restrictions.  Broad legislative factual determinations and statements of legislative intent to remove all penalties should probably be included for regulatory and judicial guidance in applying the repeal law.

The other side of the coin is that some federal regulation will need to be preserved, and possibly even strengthened.  Marijuana is, at base, an agricultural commodity.  USDA and EPA regulation of water use, fertilizer and pesticide use and run-off control, erosion control of croplands, and USDA inspection of crops to be consumed are essential. Since so many current marijuana farmers have been operating outside the law, heightened efforts may be necessary to bring them into compliance.

Since almost all marijuana is ingested, by smoking, eating, drinking, transdermally, or anally, it should be subject to existing regulations for food products under the FDA, FTC, and USDA.  If the amount of insect parts or rat feces in grain products are limited, so should those in marijuana be.  Marijuana edibles should be subject to the same purity, processing, packaging, and labelling standards as other edible products are.

A primary use for marijuana today, and one of the strongest drivers for law reform, is medical use; but medical use is also the area in which the need for continued federal regulation is strongest.  While the goal may be for the DEA and NIDA to fade away and ultimately go extinct, FDA regulation of medical uses of marijuana will remain strong.  However, this regulation should recognize a distinction between use of the unaltered plant and the use of extracts, derivatives, and synthetics.  The use of unaltered plants could be simply and adequately managed if Congress moved those uses from the Controlled Substances Act to the Dietary Supplements Act[2].  Recognized strains with stable genetics should be given protection under either trade name recognition or plant patent protection.  Derivatives and extracts should remain under the full scope of the Food, Drugs, and Cosmetics Act.  Some extract processing incorporating the use of flammable or explosive arguments require the imposition of the FDA’s best manufacturing standards.

These should all be required to complete the New Drug process, but that process presents a severe problem.  The chemistry of marijuana is well known, and many of the therapeutic uses have histories now decades long; and this history prevents patenting of molecules or procedures.  Without patent protection, no private party will invest the millions (often several hundred millions) to pursue a New Drug Application.  Some kind of fast-track process will be necessary.  Either Congress must provide it or the FDA can act administratively as they have done in the past.  When the governing law was changed to require prescriptions for many drugs and again when it was changed to require proof of efficacy, the FDA used administrative panels to authorize the use of drugs (the GRAS and GRASE lists) based on the history of their use.  The same could be done for many, but not all, uses of marijuana and extracts.

The XXIst Amendment provides a model for reforming federal marijuana law, but only a model.  The current law is much more complex than that of 1933, and a more sophisticated approach is necessary.  However, the basic federalism approach of delegating regulation to the states, which can once more be the laboratories of democracy, provides an approach that is both effective and cautious.  The approach is relatively quick and nopn-disruptive.  We should start applying it now.


[1] While marijuana is the logical first step, and may be an essential one, the same approach should work for other drugs as well.
[2] See my earlier post “Marijuana: Drug or Herb? “