Sunday, February 17, 2013

MJ, DEA, and APA

MJ, DEA, and APA

(Ladling the DEA’s Alphabet Soup)


The U. S. Court of Appeals has refused to require the DEA to reschedule marijuana out of Schedule I for the third time.  These DEA victories have come in spite of overwhelming evidence that marijuana has medical value and is widely used for medical treatment across the country.  If one were playing poker and lost three hands in a row while holding a royal flush each time, one would decide that it was time to change games or even find a new casino.

The DEA’s victories on busted hands are the result of the petitioners’ playing the wrong game in the wrong casino.  They have been playing in the agency’s own game room where the Administrator makes up his own rules.  The time has come to move the game from the DEA’s casino to the courthouse.

The route to this move lies in the Administrative Procedure Act.  This Act controls both the way administrative agencies carry out their business and the relationship between the courts and the agencies.

(This discussion is going to lead deep into the weeds of legal process, but if an interested layperson hangs on tight, the result will be worth it.)

From the creation of the Interstate Commerce Commission, Congress spent the next forty years regularly creating administrative agencies: Public Health Service, Forest Service, Bureau of Reclamation, Federal Communications Commission, Civil Aviation Authority (later FAA) and others.  But, ushered in by the Great Depression, the 1930s turned that stream into a flood, from FDIC and TVA to SEC and FDA.  The problem was that all of this alphabet soup was created on an ad hoc basis, each agency having its own legal basis and procedure.  To cope with the resulting confusion, Congress passed the Administrative Procedure Act to provide a uniform legal and procedural framework within which all agencies would function.

The Act divides administrative acts into two categories: adjudication, in which individual claims or liabilities are determined, and rule-making, in which mandates or requirements of general applicability are promulgated.  Rule-making is, in turn, divided into informal and formal (on the record) proceedings.  DEA drug scheduling is a formal rule-making procedure.

In formal rule-making, after the agency gives notice of a proposed rule, any interested party is entitled to see, and respond to, any evidence adduced and has the right to introduce evidence itself (an oral hearing is not necessary and no one has the right to cross examine).  The agency must base its final rule on the record viewed as a whole.

The APA also regulates relations between agencies and the courts.  It dealt with two problems: courts had been aggressively interfering with agencies’ ability to carry out their function and no clear delineation existed between the jurisdictions of agencies and courts.  The Act solves these problems by specifying fact-finding authority and by defining jurisdictions for clarifying or interpreting statutes.

Agencies are given almost complete fact-finding autonomy under the act.  In informal proceedings, a court must uphold an agency’s findings unless they are arbitrary and capricious.  In other words, an agency determination will not be set aside unless it is completely unreasonable.  In formal proceedings, factual determinations will be upheld if they are supported by substantial evidence considering the record as a whole.  Substantial evidence is defined as more than a scintilla but less than a preponderance.  These two standards must be compared to the fact-finding standards a trial court must meet to avoid having its verdict set aside on appeal.  In a civil action, a verdict must be supported by a preponderance of the evidence.  In order words, the evidence must show the factual findings are more likely than not.  In criminal cases, a trial fact-finding will only be upheld if the evidence supports it beyond a reasonable doubt: to a moral certainty.  Laying out this spectrum of burdens of proof shows how nearly unassailable an administrative finding is.

As far as questions of law are concerned, courts have greater, but not absolute, powers.  After all, in the American system of government, the courts are the experts in interpreting and applying the laws.  The courts are the ultimate judges of the constitutionality of both statutes and administrative actions.  Similarly, courts are experts in statutory construction, but they are required to give due deference to an administrator’s construal of a statute when useful in carrying out the duties of the agency.

Now that the weeds have been chopped down – or at least pushed to the side, the problem of marijuana scheduling can be analyzed.

In three attempts at rescheduling marijuana spread over forty years, proponents have done an outstanding tactical job of marshalling the facts behind the marijuana claims for marijuana.  But to some extent blinded by their own conviction of the worth of medical marijuana, they failed strategically both by choosing the wrong battle and the wrong battlefield.  They have been fighting over the facts when they should be fighting over the law.  By making the issue one of whether marijuana had medical value or not, the issue became one in which a the biased DEA administrator became the referee of the factual dispute and one in which the standard of review was the extremely low substantial evidence test.  They were virtually guaranteed to lose this battle.  Suppose they introduced 999 clinical studied published in refereed medical journals showing medical effectiveness and the government introduced one article by a salaried NIDA hack appearing in a government publication.  That one article would be enough substantial evidence to prevent a court from overturning an administrative finding of no medical use.

The better strategy would be to avoid the DEA’s stacked deck of factual dealing and find a way to move the battle to the courts, where the DEA would be merely a combatant instead of being the referee.  In other words, the fight should be about the statute itself and not about the facts to which it is applied.

The vulnerable point of the DEA’s application is in the statutory language defining Schedule I drugs as those having no “currently accepted medical use in the United States”.  The DEA applies this as if it read “actual medical efficacy”, but this reading is fatally flawed on two grounds.  First, it assumes an unconstitutional power for the agency, and second, it is an interpretation of the statutory language that grants power to the agency in excess of that which congress authorized.

The Supreme Court, for eighty years, has consistently held that congress has no authority to regulate the practice of medicine, including the determination of what is medicine, that being an integral part of the states’ inherent police powers.  Congress has recognized this limitation: it has created the FDA with only an indirect method for regulating drugs.  The FDA is limited only to the prevention of the misleading or deceptive marketing of drugs and is given the authority to prevent misleading by requiring an approved label for the sale of any drug.  That label must be based on the scientific proof that the drug is safe and effective for the treatment of some medical condition.  Any attempt by the DEA to regulate the practice of medicine by declaring what is or is not a medicine is unconstitutional.  (See my earlier posting, “Currently Accepted Medical Use” for a further exploration of this argument.)

The DEA is also exceeding its statutory authority.  Congress only authorized it to determine accepted medical practice, not medical effectiveness.  The history of the FDA and the Pure Food and Drug and Food, Drug and Cosmetics Acts shows that congress was aware of the constitutional limitations on federal regulation of medicine.  Congress knew the difference between medical practice and medical effectiveness.  It required the FDA to get proof of medical efficacy only eight years (1962) before it defined Schedule I drugs as those without medical use.  Congress would also have avoided delegating proof of effectiveness to two different agencies both in the interest of efficiency and to avoid conflicting determinations.  The only reasonable conclusion is that congress did not authorize the DEA to determine medical effectiveness.

The strategy is clear.  Anyone wanting to argue the medical effectiveness of marijuana should do so in the medical journals.  Anyone wanting to reschedule marijuana from Schedule I should force the courts to rule on the constitutionality and construction of the statutory authority of the DEA.  The strategy is clear; now the talented litigators and appellate specialists must find the tactics to get these issues before the courts.

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