Tuesday, December 20, 2011

Marijuana: Drug or Herb? (Part II)

Marijuana: Drug or Herb? (Part II)

While I was writing “Marijuana: Drug or Herb?” (posted 12/11/11), a small idea started nibbling at the far corners of my mind.  That nibbling has grown into a constant gnawing, so with a large measure of diffidence, I am sharing that idea with you.  I warn you that this idea goes far beyond my areas of competence, but my hope is that someone with greater knowledge than mine (a very low standard) of the production, distribution, and prescription regulations of the Drug Abuse Control and Prevention Act, FDA practice, and regulation of dietary Supplements will either shoot it down completely or flesh it out into a viable theory.

Rescheduling marijuana out of the totally prohibited drugs of Schedule I has been a major effort of drug law reformers for more than forty years – longer than the professional lives of most of those concerned.  In the last few years many of those reformers have become concerned about what will happen if marijuana is rescheduled.  The consensus has been that, if it is to be legally distributed, marijuana will have to pursue a New Drug Application through the FDA – an arduous and costly procedure.  But is that consensus necessarily correct?  Answering this question requires looking at the total federal scheme for regulating drugs.

Speaking broadly (and ignoring literally dozens of amendments), federal drug regulation rests on four statutes: the Food, Drug and Cosmetics Act (FDCA), the Drug Abuse Control and Prevention Act, Part I (DACP), the Controlled Substances Act (CSA, which is Part II of the DACP), and the Dietary Supplement Health and Education Act (DSHE).  These acts were passed over a sixty-year period and contain many overlaps while allowing gaps to remain in their coverage.

The FDCA controls the marketing of all drugs affecting interstate commerce.  Any drug without an FDA approved label will be presumed misbranded, and therefore its sale would be deceptive and misleading.  That label must include information about at least one medical use for which the drug has been proved, to the satisfaction of the FDA, to be both effective and safe.  Because it is constitutionally barred from regulating the practice of medicine, the FDA cannot require doctors to use those drugs for their proven uses nor can it bar doctors from prescribing those drugs for other, non-labeled uses.  This latter practice of off-label prescribing is wide-spread.  Hair restoration was originally an off-label use of Rogaine.

Two exemptions to FDA jurisdiction are recognized.  The Supreme Court has held that Congress intentionally exempted alcohol and tobacco (two truly dangerous drugs) from regulation by the FDA (and by implication, from the DEA).  The DSHE conditionally exempts dietary supplements, including herbs, from FDA regulation.  The FDA only retains what may be called “watching jurisdiction”.  If sufficient evidence exists that the supplement is misbranded or marketed in a deceptive or misleading fashion (normally by making health claims), the FDA may remove the product from the market until the distributor has obtained an NDA.

The DEA has the authority under the CSA to find that a drug has a potential for abuse.  If it so finds, the DEA may bar its manufacture, distribution, or possession (by placing the drug in Schedule I) or regulate the method by which it is distributed (by placing it in Schedules II – V).

Once a drug is in Schedules II –V, the DACP controls the way in which the DEA (originally the BNDD) regulates the manufacture, inventory, and distribution of that drug.  If the FDA has ruled the drug to be available only on prescription, the DEA also regulates the manner in which that prescription is processed and filled.  Neither the FDA nor the DEA may require or forbid a doctor to employ a drug other than those in Schedule I; and only the FDA – not the DEA – may determine that a prescription is required for the dispensing of a drug.  But the DSHE exempts dietary supplements, including herbs, from pre-sale FDA jurisdiction.  The FDA can intervene in the distribution of supplements only if the distributor has violated the statutory restrictions imposed by that act.

What if marijuana were rescheduled – either by agency action or by court order (see “The Cornerstone of American Drug Policy”, posted 12/1/11)?  The most logical placement of marijuana would be in Sched. V, but placement in Sched. II, in the uncomfortable company of morphine, fentanyl, methadone, cocaine, amphetamine, methamphetamine, and Ritalin, is more likely.

As a scheduled controlled substance, marijuana producers and distributors would be subject to more (if Sched. II) or less (if Sched. V) stringent requirements for security, storage, inventory, transportation, and reporting.  But purchasers and end-users would only have to deal with state requirements.  In the sixteen jurisdictions with medical marijuana laws, those meeting the medical needs requirements could purchase freely without the necessity of a prescription.  No prescription could be required (unless imposed by state law) because the DEA is without power to require prescriptions (it can only regulate the methods by which prescriptions are handled) and the FDA would have to recognize that, marijuana being an herb, it could only act after distributors violated the limits imposed by the DSHE.  No NDA or proof of efficacy and safety could be required.

So far, all that has been demonstrated is that I still possess the Law Professor’s uncanny ability to construct complex and implausible hypothetical cases with which to confuse – and possibly enlighten – the class.  Now it’s your turn.  Can the real lawyers out there either point out the fatal flaws in the hypothetical or build it into a useable theory?  Let’s see what you can do!


Sunday, December 11, 2011

Marijuana: Drug or Herb?

Marijuana: Drug or Herb?

The main focus of the drug law reform movement for over forty years has been to force the DEA to move marijuana from Schedule I, making unlawful any production, distribution, or possession, to one of the less stringent schedules (II-V), in which it could be made available for medical use.  However, many have lately realized that merely rescheduling marijuana would not make it available to patients in need; its sale or distribution would still be totally blocked by lack of FDA approval for movement in commerce as a drug.

Students of classical logic or rhetoric will recognize this situation as placing marijuana on the horns of a dilemma.  One of those horns impales marijuana on DEA prohibition, while the other gores it with the lack of FDA approval.  In either case, the medical use of marijuana is impossible.

But that same student knows that the resolution of a dilemma is to go between the horns – to find a third solution, avoiding the bad outcomes threatened by the two choices presented.  Congress has already set up a third solution that would allow marijuana to avoid both DEA prohibition and FDA regulation.  Congress should recognize that, according to its own regulatory scheme, marijuana is not a drug: it is an herb.

Federal law provides three systems for regulating physiologically active substances.  The most comprehensive is the regulation of the marketing of drugs in or affecting interstate commerce by the FDA.  The sale of any drug not bearing an approved FDA label is deceptive and misleading, and therefore forbidden.

Those drugs with some potential for abuse (not defined in the statute) are regulated by the CSA.  Those with no medical use (Schedule I drugs) may not be lawfully produced, sold, or possessed.  Drugs in the less restricted schedules (II-V) have some demonstrated medical use and may be sold, but only under the regulation of both DEA and FDA.  The many drugs legally sold under dual regulation by DEA and FDA include morphine, OxyCotin, cocaine, methamphetamine, and Ritalin.

However, not all products meeting the definition of drugs under the CSA and FDCA (briefly, a substance ingested for the purpose of affecting bodily or mental function) are subject to these two agencies.  In 1996 congress enacted the Dietary Supplement Health and Education Act.  That act allowed the marketing of dietary supplements, herbal preparations, and vitamins without FDA prior approval so long as no health claims were made on the packaging or in the advertising of the product.  The preparations covered by this act include St. John’s wort and kavakava, both taken for their supposed psychoactive effects.  These effects should otherwise bring them under the CSA and DEA control.

(Congress has apparently created a fourth category of drug regulation as well.  In ruling against the FDA’s proposed attempt to regulate cigarette marketing, the Supreme Court held that the failure of congress to expressly include tobacco and alcohol in either the FDCA or the CSA established a clear congressional intent not to regulate these drugs.  This fourth category containing of drugs that are not regulated consists of two of the most dangerous and addicting substances people have ever ingested.)

The question then becomes whether marijuana is a drug, a controlled substance, or a dietary supplement.  Of those three categories, marijuana (and possibly psilocybin mushrooms and mescaline cacti) seems to best fit as a dietary supplement.  Supplements are statutorily defined  as:

`(gg) The term `dietary supplement' means a food for special dietary use, as defined in section 411(c)(3), that--

`(1) includes--

`(A) a vitamin;

`(B) a mineral;

`(C) an herb;

`(D) an amino acid;

`(E) another ingredient for use by man to supplement the diet by increasing the total dietary intake; or

`(F) a concentrate or extract of any ingredient described in clause (A), (B), (C), (D), or (E); and

`(2)(A) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

`(B) complies with section 411(c)(1)(B)(ii).'.21 U.S.C. 411.

These naturally occurring substances are significantly different from the single-molecule drugs normally covered by the stricter FDCA and CSA.  Congress, in the Dietary Supplement Health and Education Act has already provided a model of this kind of restructuring:

(b) EXCLUSION FROM DEFINITION OF DRUG- Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by adding at the end the following new sentence: `The term `drug' does not include a dietary supplement or an ingredient described in clause (A), (B), (C), (D), (E), or (F) of paragraph (gg)(1) in, or intended for use in, a dietary supplement.'.

That section could be amended to read: “…Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) and Drug Abuse Control and Prevention Act of 1970[1] are amended by adding at the end the following new sentence: `The term `drug' does not include a dietary supplement, including any plant or parts of plants of the genus Cannabis,…”

This reform might be more feasible than either decriminalization or legalization.  A member of congress would be merely streamlining regulation to make it more reasonable.  He would not have to face voters in defending his “soft on crime” vote to legalize dope and free hordes of fiends on the highways and around the school yards.

Marijuana is only an herb like St. John’s wort and kava, not a drug like heroin or methamphetamine.  It is time to treat it like one.  Please pass the cannabis brownies.

[1] Which included the Controlled Substances Act as Part II

Thursday, December 1, 2011

The Cornerstone of American Drug Policy

The Cornerstone of American Drug Policy

The cornerstone of American drug policy is the Controlled Substances Act of 1970, and the cornerstone of that act is the scheduling scheme.  That act divides controlled substances into five categories, or schedules.  Drugs in Schedule I, which include marijuana, heroin, LSD, peyote, and MDMA among others, may not be manufactured, distributed, or possessed by anyone. The definition of Schedule I drugs is therefore the cornerstone of the scheduling process.

To be classified in Schedule I, a drug must have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and cannot be used safely under medical supervision.  None of these three primitives are defined in the act and have not been clarified by the courts.  But the problematic element is the second.  What is “currently accepted medical use in treatment in the United States”?

Two meanings of this phrase are possible.  The first is to treat the language as requiring the DEA to look into the actual medical efficacy of the drug as shown by medical science.  This meaning has been followed by the Drug Enforcement Agency in proceedings to reschedule marijuana and MDMA since 1972. The courts have never examined this definition, all but one of the appeals on marijuana having been decided on procedural grounds.  Even in original NORML case, the court never reached the substantive issues.

The second possible meaning is that the issue is strictly one of demographics.  Under this theory, the DEA has no competency to examine the scientific and medical questions, but must limit itself to determining what, in fact, doctors do in the course of treating patients.  In other words, the question becomes one of whether a substantial number of doctors treat marijuana or MDMA is a therapeutic agent when dealing with their patients and whether other doctors approve or disapprove of that use.

An examination of the development of the regulation of both legal and illegal drugs indicates that the second reading, limiting the DEA to the question of what doctors do in practice, is more consistent with current constitutional law.  That story began soon after the enactment of the Harrison Narcotic Tax Act in 1914.

That act criminalized a doctor’s dispensing or prescribing an opiate to a patient outside of the normal course of medical practice.  The government began prosecuting doctors who furnished morphine or heroin   for the purpose of maintaining their habits (much like methadone is used today), claiming that maintaining addicts in a stable, functioning life was not part of the normal practice of medicine.

The Supreme Court considered that question three times before deciding that Congress had no constitutional authority to say what was “the practice of medicine”.  In Linder (1925) the Court held that medical practice was not part of interstate commerce and, consequentially, the power to regulate medicine, including determination of what is or is not medicine, is reserved solely to the states.

While the Supreme Court has discussed medical marijuana in over twenty opinions, it has not directly dealt with this problem of interpretation of the CSA.  However, in Conant v. Walters (2002), the Ninth Circuit applied this reasoning in holding that the federal government, acting under the CSA, could not prevent a state-licensed doctor from recommending the use of marijuana to a patient.  So far the DEA has not presented the issue to another circuit.

Congress was faced with this exclusion of the federal government from the regulation of medicine when it created the Food and Drug Administration through the Food, Drug, and Cosmetics Act in the1930s.  The purpose of the act was to insure food and drug safety, but since Congress could not regulate drugs directly, indirect action was called for.

Consequently, the FDA was not given power to approve drugs, but instead, it was empowered to prevent drugs from being sold in a deceptive or misleading manner.  A drug sale would be misleading and deceptive unless that drug bore a label approved by the FDA. That label would be approved only if it were substantiated by valid scientific tests that the drug was safe for the intended use.

That method of regulating drugs by controlling their marketing was continued as the FDCA was amended, first in the1950s to separate prescription and over-the-counter drugs and then in the 1960s to require scientific proof of efficacy for at least one medical use before a label could be approved.  The Supreme Court has approved this distinction in cases involving the rights of doctors to prescribe drugs for “off label” uses, treatment of conditions not included on the label, although manufacturers have been punished for publicizing or advertising those uses.  Doctors distributing drugs which they themselves had produced and furnished to their own patients as part of a broader therapy and not using the instrumentalities of interstate commerce have also been held to be outside the jurisdiction of the FDA.  The most recent case, Gonzales v. Oregon (2005), prevented the DEA from taking action against doctors acting under Oregon’s assisted suicide law.

A determination of "efficacy" seems very close to determining medical utility - since efficacy seems to imply "effective in treating a disease" "relieving symptoms" "boosting health functions" etc. What is the difference?

This constitutional derivation strongly favors the interpretation that the DEA is limited to asking only what doctors are, in fact, doing and is barred from inquiring into the medical or scientific value of the drug.  The statutory language itself reinforces this interpretation.  The statute specifies “currently accepted medical use”; Congress could have easily used “medically effective” or “substantial medical value” if the intent had been to empower the DEA to conduct independent scientific investigations.  Congress did, in fact, empower the FAA, FCC, and NTSB with those kinds of direct powers in regulating airplanes, broadcast stations, and trucks and buses: all direct instrumentalities of interstate commerce.

The DEA’s own Administrative Law Judge applied a “medical use” standard in the first two contested scheduling proceedings under the CSA: the first marijuana petition and the proceeding for the emergency scheduling of MDMA. The politically appointed Administrator reversed his recommendations in both cases.  In the MDMA proceeding, the Administrator rejected the ALJ’s findings, equating “medical use” with “approved by the FDA”.  The Court of Appeals (Grinspoon, First Circuit,1987)  rejected this interpretation and remanded the case for further consideration.

If the courts were to require the DEA to use a medical use standard instead of a medical value standard, rescheduling of marijuana and MDMA would necessarily follow, allowing them to be sold through normal medical channels; and the rescheduling of psilocybin, LSD, mescaline, and possibly heroin and ibogaine would be likely. These drugs, while having no, or little, current medical use, could be covered by a “but for…” argument.  Each of them had thriving medical use and widespread favorable medical reporting before they were classified as Schedule I drugs.  But for that classification, their medical use would probably be common today.  Heroin, for instance, is routinely used in many countries with developed, sophisticated medical systems.  This information would be probative in a rescheduling action.  If coupled with expert opinions about the scope of its use by American physicians and pharmacologists, it should be persuasive.

Since the passage of the CSA medical use of marijuana has blossomed even while forbidden.  Thousands of refereed medical papers have been published,  its effectiveness. Sixteen jurisdictions have enacted medical marijuana laws, and well over a million patients now regularly use medical marijuana under those laws.  The undercover illegal use by patients in other states could easily double that total.

Marijuana has now met the statutory requirements that necessitate its removal from the absolute prohibition of Schedule I.  It has been shown to be qualified as a drug available for a doctor’s prescription just like OxyCotin, cocaine, and methamphetamine. All that is necessary is for the DEA to apply the law as written.