Flashback to the Federal Analog Act of 1986: mixing rules and standards in the Cauldron.

• Author: Kau, Gregory

INTRODUCTION I. WHAT ARE DESIGNER DRUGS AND WHERE DID THEY COME FROM? A. The Federal Analog Act: History of Designer Drugs B. The Source of Designer Drugs: A Close Relationship Between the Pharmaceutical Industry and Clandestine Chemists C. Designer Drugs: Legal Loopholes and Problems II. RULES VERSUS STANDARDS AND THE CURRENT STATE OF DESIGNER DRUG LEGISLATION A. Rules Versus Standards: A Witch's Brew of Approaches in Controlled Substance Analog Legislation B. Rules and Standards: Different Ingredients for Different Flavors 1. Costs 2. Deterrence 3. Fairness Concerns III. PROPOSED CHANGES A. Mixing Rules and Standards in the Federal Analog Act: Putting It All in the Cauldron B. Practical Implementation: Changes to the Federal Analog Act C. Institutional Responses CONCLUSION INTRODUCTION

In 1982, a forty-two-year-old heroin addict staggered into a San Jose medical clinic. (1) His muscles were virtually frozen in place, so much so that "he seemed more of a mannequin than a man." (2) Upon closer examination, the attending neurologist found that the patient exhibited symptoms of advanced Parkinson's disease. (3) The neurologist was astonished: Parkinson's rarely struck before the age of fifty. (4) The parties responsible for this early onset of Parkinson's were two legal professionals who moonlighted as clandestine drug chemists. (5) In the basement of their law office, they produced 1-methyl-4-propionoxy-4-phenylpyridine (MPPP), a synthetic version of heroin that was perfectly legal to manufacture. (6) Unfortunately, the entrepreneurs were better lawyers than chemists. Even though they found the correct recipe for their concoction, they failed to keep the reaction at the proper temperature and acidity. (7) As a result, they unknowingly introduced a highly poisonous by-product into the brew that caused severe brain damage: The chaos that ensued was the first "designer drug disaster" recorded in American history. (9)

The federal government was powerless to prosecute this behavior under existing federal drug statutes. The perpetrators had--quite literally--played by the rules, and had properly exploited loopholes to avoid punishment. Other clandestine chemists were inspired and followed their lead. Public pressure on Congress escalated as designer drugs spread around the world. (10) In this atmosphere of panic, Congress responded (11) by enacting the Federal Analog Act (12) with the express purpose of preventing minor structural modifications to drugs prohibited under Schedule I of the Controlled Substances Act in order to evade legal penalty. (13) The Federal Analog Act replaced rules with standards. Under the Federal Analog Act, if a chemical is "substantially similar" in structure and pharmacological effect to a drug prohibited by the Controlled Substances Act, this chemical is also prohibited. In the words of one Senator, "if it looks and quacks like a duck--then it's a duck." (14) The Federal Analog Act is arguably one of the furthest-reaching federal drug laws enacted in the United States, prohibiting numerous chemical permutations and treating these substances on par with other Schedule I drugs like lysergic acid diethylamide (LSD) and heroin. (15)

Twenty years later, the backlash against "designer drugs" has begun to subside. (16) Doctors and pharmacologists are beginning to take cautious steps toward reevaluating the medical value of these compounds. (17) It is now possible to revisit the Federal Analog Act and examine whether replacing rules with standards was the correct move. This Comment focuses on the structural prong of the Federal Analog Act (18) and argues that a rules-standards hybrid definition of a controlled substance analog under the Federal Analog Act offers both practical and theoretical advantages to the current standards-based incarnation. After providing a brief overview of the "designer drug" phenomenon, Part I introduces the Federal Analog Act. Part II considers the rules versus standards debate in the context of "designer drugs" and discusses advantages and disadvantages associated with each model. Part III explores peculiar problems that arise from the Federal Analog Act's current standards-based implementation, explores justifications for deploying a hybrid rules-standards approach to the Federal Analog Act, and considers possible methods of implementing a hybrid rules-standards approach in the Federal Analog Act.

1. WHAT ARE DESIGNER DRUGS AND WHERE DID THEY COME FROM?

   1. The Federal Analog Act: History of Designer Drugs

      The Federal Analog Act was originally called the "Designer Drug Enforcement Act." (19) Instead of requiring the Drug Enforcement Administration (DEA) to promulgate a rule banning each chemical as it emerges on the black market, the Federal Analog Act automatically prohibits a chemical if it is "substantially similar in structure" to an already-prohibited drug, and has a "substantially similar chemical effect" or is "represented to have such an effect." (20) The Federal Analog Act classifies these controlled substance analogs as Schedule I drugs (21)--the most stringently controlled drugs in the United States, including heroin and LSD. (22) To understand how the Federal Analog Act operates in the context of drug trends, it is useful to explore a brief history of federal controlled substance legislation and designer drugs in the United States.

      The cultural upheaval of the 1960s brought a vast proliferation of recreational drugs to America. In 1973, President Richard Nixon declared an "all-out global war on the drug menace." (23) "Right now," he said, "the federal government is fighting the war on drug abuse under a distinct handicap, for its efforts are those of a loosely confederated alliance facing a resourceful, elusive, worldwide enemy." (24) In an effort to contain the burgeoning drug epidemic, Congress enacted the Controlled Substances Act of 1970, the first comprehensive federal drug prohibition legislation. (25) President Nixon also sent Reorganization Plan No. 2 to Congress, creating the DEA and tasking it with enforcing the Controlled Substances Act of 1970. (26)

      From 1973 through 1980, the DEA fought the influx of stock controlled substances--such as cocaine, marijuana, and heroin--on an international scale. The DEA infiltrated Colombian cocaine and marijuana cartels, broke up Mexican heroin syndicates, and shut down central Asian drug pipelines. (27) However, the 1980s opened up a new domestic front in the War on Drugs. Synthetic drugs came into vogue again--drugs like methamphetamine, 3,4-methylenedioxy-N-methylamphetamine (MDMA), and 3,4-methylenedioxyamphetamine (MDA). Unlike stock drugs such as cocaine and heroin, synthetic drugs did not require a large initial investment and the support infrastructure of an international cartel. Instead, a small laboratory, supplied with a cheap investment of precursor chemicals and reagents, could produce a staggeringly large number of doses. (28) Furthermore, a laboratory was easily concealed and moved from state to state to avoid detection. The United States faced a new menace that seemed to be everywhere and nowhere at once. Synthetic drugs brought the War on Drugs to home turf. The old enemy--stodgy drug syndicates abroad--was dwarfed by a new fluid adversary, at home.

   2. The Source of Designer Drugs: A Close Relationship Between the Pharmaceutical Industry and Clandestine Chemists

      The term "designer drug" was originally coined to describe these seemingly novel concoctions. But twenty years later, this branding has proved to be misleading. As the DEA noted, the label "designer drug" "tends to cast a somewhat glamorous aura onto the concept" (29)--a perception that is especially misguided considering that designer drugs are not new at all. Virtually all "designer drugs" are either legitimate pharmaceutical products on the market or potential products that were synthesized in medical research and development (30) but discarded because they didn't produce an intended effect. As Albert Hofmann--the first chemist to synthesize LSD (31)--explains:

      When a new type of active compound is discovered in pharmaceutical-chemical research, whether by isolation from a plant drug or from animal organs, or through synthetic production as in the case of LSD, then the chemist attempts, through alterations in its molecular structure, to produce new compounds with similar, perhaps improved activity, or with other valuable active properties. We call this process a chemical modification of this type of active substance. Of the approximately 20,000 new substances that are produced annually in the pharmaceutical-chemical research laboratories of the world, the overwhelming majority are modification products of proportionally few types of active compounds. The discovery of a really new type of active substance--new with regard to chemical structure and pharmacological effect--is a rare stroke of luck. (32) As new pharmaceuticals emerged in academic and industrial research, clandestine chemists and drug distributors found a winning business strategy. They would wait until a psychoactive compound was discovered, and then they would copy and sell it. When researcher Albert Hofmann of Sandoz, Inc. discovered LSD-25 and began exploring its different variations, (33) clandestine chemists hijacked the molecule and sold it on the black market. Similarly, in the 1980s, Alexander Shulgin of Dow Chemical--an eminent Berkeley pharmacologist who The New York Times called a "one-man psychopharmaceutical research sector" (34)--discovered and rediscovered hundreds of variations on phenylethylamines and tryptamines. One of these was MDMA (known commonly as Ecstasy), a forgotten compound discovered by German pharmaceutical company Merck in 1912 that had been relegated to obscurity in dusty old academic journals. (35) Shulgin's discoveries were hijacked by clandestine chemists and released into the black market. This misappropriation fueled...