Half a century ago, Congress approved the Controlled Substances Act (CSA), which established a system for classifying drugs based on their "medical use" and "potential for abuse."
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which → approve → abuse
But as a recent report from the Government Accountability Office (GAO) notes, the statute does not clearly define either criterion, opening the door to debatable and changeable regulatory judgments with far-reaching criminal justice implications.
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statute → note → implications
Schedule I of the CSA is supposedly reserved for drugs that have "a high potential for abuse," "no currently accepted medical use," and "no accepted safety for use under medical supervision."
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that → reserve → supervision
Those drugs, which include heroin, LSD, psilocybin, and MDMA, are prohibited except for government-approved research purposes.
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which → include → purposes
Schedule II drugs, which include cocaine, methamphetamine, fentanyl, morphine, hydrocodone, and oxycodone, also are deemed to have "a high potential for abuse."
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which → include → abuse
But their medical use is "accepted," and they are legally available by prescription.
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they → accept → prescription
So are drugs in Schedules III, IV, and V, which are supposed to have progressively lower abuse potential, justifying less severe criminal penalties for unauthorized possession and distribution.
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which → suppose → possession
Right away we see a problem: A drug with "potential for abuse" short of "high" but no "accepted" medical use does not fit into any of these schedules.
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drug → see → schedules
The historical treatment of cannabis illustrates that puzzle.
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treatment → illustrate → puzzle
When Congress enacted the CSA in 1970, it placed marijuana in Schedule I, and the Drug Enforcement Administration (DEA), which had the authority to reclassify drugs in consultation with the Department of Health and Human Services (HHS), kept it there, rejecting a series of petitions arguing that it did not meet the statutory criteria.
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it → enact → criteria
Beginning in 1992, the GAO notes, the DEA defined "accepted medical use" based on five criteria, including "adequate safety studies" and "adequate and well-controlled studies proving efficacy."
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DEA → begin → efficacy
Since those requirements are similar to the evidence that the Food and Drug Administration (FDA) demands to approve a drug for prescription use, the DEA's definition essentially equated "accepted medical use" with FDA approval.
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definition → demand → approval
During the Biden administration, the HHS embraced an alternative test for "accepted medical use" that considers "widespread" clinical experience with a drug (in the 41 states that have legalized medical marijuana, for example) and requires "some credible scientific support" for at least one application.
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that → embrace → application
Based on an FDA analysis, HHS said cannabis passed that test and, after reconsidering its "potential for abuse," recommended placing it in Schedule III, which includes prescription drugs such as ketamine, anabolic steroids, and Tylenol with codeine.
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which → base → codeine
Last April, Acting Attorney General Todd Blanche issued a final rule that followed the HHS recommendation, but with a twist.
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that → issue → twist
For the time being, he said, only marijuana products currently sold by state-licensed medical dispensaries or approved in the future by the FDA would qualify for Schedule III.
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products → say → Schedule
The scientific and legal logic of that decision was hard to follow, since the included and excluded products are pharmacologically identical, distinguished only by their intended use.
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products → follow → use
By contrast, cocaine, fentanyl, and methamphetamine are all Schedule II drugs, regardless of whether they are dispensed by pharmacies based on medical prescriptions or purchased on the black market without legal authorization.
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they → dispense → authorization
In any event, the government's reversal on cannabis showed how malleable the CSA's scheduling criteria are.
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criteria → show → cannabis
The drug's reclassification hinged on a change in attitude rather than a change in the underlying science.
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reclassification → hinge → science
In addition to a redefinition of "accepted medical use," that shift entailed a new assessment of marijuana's abuse potential.
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shift → accept → potential
The CSA "does not include a statutory definition of 'potential for abuse,'" the GAO notes, and "FDA officials told us that the lack of a written definition…presented challenges for determining the relative abuse potential and appropriate schedule recommendation for some substances."
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lack → include → substances
The GAO thinks the FDA should specify "the criteria and process for determining a substance's 'potential for abuse.'"
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FDA → think → abuse
The lack of clarity highlighted by the report is astonishing, given how long Americans have been living with the CSA, which criminalizes a wide range of peaceful conduct and prescribes penalties based on arbitrary bureaucratic distinctions.
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which → highlight → distinctions
The Aporia
