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Flashback to the Federal Analog Act of 1986: Mixing Rules and Standards in the Cauldron
>Download Full Article (PDF file, 265 KB) In 1982, a forty-two-year-old heroin addict staggered into a San Jose medical clinic. His muscles were virtually frozen in place, so much so that “he seemed more of a mannequin than a man.” Upon closer examination, the attending neurologist found that the patient exhibited symptoms of advanced Parkinson’s disease. The neurologist was astonished: Parkinson’s rarely struck before the age of fifty. The parties responsible for this early onset of Parkinson’s were two legal professionals who moonlighted as clandestine drug chemists. 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. 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. 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. 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. In this atmosphere of panic, Congress responded by enacting the Federal Analog Act 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. 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.” 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. Twenty years later, the backlash against “designer drugs” has begun to subside. Doctors and pharmacologists are beginning to take cautious steps toward reevaluating the medical value of these compounds. 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 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. |
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