Denial of Marijuana Reclassification Appealed to Supreme Court

July 24, 2013

Josh Crank, Lawyers.com

Medical marijuana advocates want the United States Supreme Court to hear an appeal that could lead to marijuana’s removal from Schedule I of the Controlled Substances Act.

Americans for Safe Access appealed a January decision from the District of Columbia U.S. Circuit Court that found a lack of “adequate and well-controlled studies” proving the medical efficacy of marijuana. Even though plaintiffs presented more than 200 peer-reviewed studies, the three-judge panel concluded that the studies did not meet certain standards and that the DEA was within its rights to refuse to reschedule marijuana.

Drugs listed under Schedule I have “high potential for abuse” and “no currently accepted medical use in the United States.” Despite the legalization of medical marijuana in 19 states and Washington D.C., marijuana remains on Schedule I alongside heroin and LSD. It is more tightly controlled than Schedule II drugs like cocaine and methamphetamine.

Decade in the Making

The petition for the DEA to reschedule marijuana was initially filed in 2002 by the Coalition to Reschedule Cannabis, a group of marijuana advocacy organizations including Americans for Safe Access. The effort was stalled for nearly a decade until the DEA finally denied the petition in 2011, saying the rescheduling of marijuana was unwarranted due to “limited existing clinical evidence.”

The petitioners appealed, arguing that the DEA’s dismissal of the request was “arbitrary and capricious.”

But when the appeal came before the circuit court, the judges felt that the DEA was best suited to interpret the requirement of “adequate and well-controlled studies proving efficacy.” The DEA felt this requirement meant FDA-approved Phase II and Phase III clinical trials, which not only evaluate a drug’s medical efficacy but also its commercial potential.

Joe Elford headshot

Joe Elford

Americans for Safe Access Chief Counsel Joe Elford said the circuit court’s decision creates an “essential conflict” with another appeals court decision from 1987. In that case, which involved a Harvard professor who wanted to conduct research on the therapeutic potential of ecstasy, the court ruled that a drug’s failure to obtain FDA marketing approval can’t be taken to mean it has no medical value.

“To deny that sufficient evidence is lacking on the medical efficacy of marijuana is to ignore a mountain of well-documented studies that conclude otherwise,” Elford said. “The Court has unreasonably raised the bar for what qualifies as an ‘adequate and well-controlled’ study, thereby continuing the government’s game of ‘Gotcha.’”

Drug Comparisons Overlooked

The appeal also accuses the DEA of failing to consider the abuse potential of marijuana as compared to other controlled substances. The Controlled Substances Act requires these comparisons to find the appropriate place for a substance on the schedule. For example, Schedule III drugs must have abuse potential “less than the drugs or other substances in schedules I and II.”

Elford wrote in the appeal that the Circuit Court appeals panel “simply ignored that marijuana has an extremely low abuse potential relative to other controlled substances, despite having been presented voluminous evidence.”

Bureaucratic Cycle Blocks Research

The federal government has established a cycle that virtually guarantees marijuana’s Schedule I status until Congress or a court forces the DEA to reschedule it.

Researchers who want to conduct medical marijuana studies have to obtain approval from the Department of Health and Human Services. Health officials make it extremely difficult to obtain that approval, let alone the marijuana itself, citing the Schedule I classification as the reason for such strict control.

And of course, that classification is determined by the DEA, which justifies the decision based on a lack of clinical research. No research without rescheduling, and no rescheduling without research.

“The Obama Administration’s legal efforts are keeping marijuana out of reach for millions of qualified patients who would benefit from its use,” Elford said. “It’s long past time for the federal government to change our country’s harmful policy on medical marijuana, and if it must be compelled to do so by the courts then so be it.”



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