Marijuana Advocates Ask High Court To Mull Reclassification

July 18, 2013

Erica Teichert, Law360

Several medical marijuana advocacy groups has asked the U.S. Supreme Court to weigh in on whether U.S. Food and Drug Administration recognition of acceptable medical uses for the drug is necessary before the Drug Enforcement Administration can relax marijuana restrictions, claiming that requirement is too high.

Americans for Safe Access, the Coalition to Reschedule Cannabis, Patients out of Time and several individuals alleged in a petition for certiorari submitted July 15 that the D.C. Circuit and the DEA have placed too much clout in FDA approval and have ignored peer-reviewed studies that focused on the potential medical purposes of marijuana use. According to the petitioners, marijuana use could treat issues stemming from AIDS, chronic pain and the negative effects of chemotherapy.

But a three-judge D.C. Circuit panel ruled in January that FDA-approved clinical trials would be necessary to validate those medical uses and justify reclassifying marijuana from a Schedule I drug to a schedule III, IV or V drug. Marijuana's Schedule I status restricts the production, sale and use of marijuana under federal law.

However, advocates claim the D.C. Circuit and DEA are ignoring other necessary drug characteristics, such as safety and abuse potential, that could also justify the reclassification.

“The DEA fails to compare the abuse potential of marijuana to other scheduled substances, as the [Controlled Substances Act] requires,” the petition said. “It is only failing to apply the appropriate standards and make the required comparisons that the federal government could conclude that marijuana is as harmful as heroin and PCP and even more harmful than methamphetamine, cocaine and opium, and should remain in the CSA's most restrictive Schedule I.”

Instead, the petitioners allege the D.C. Circuit has advocated “blind reliance” on FDA approval, which goes beyond Congress' intentions when it enacted the CSA and beyond the government's arguments prior to the decision.

“The government itself did not contend that Phase II or Phase III FDA-approved studies are necessary to a finding that a substance has a currently accepted medical use for treatment in the United States in its respondents' brief,” the petition said. “It is plainly possible that a substance may fail to obtain interstate marketing approval even if it has an accepted medical use.”

The petitioners also noted that 18 states and the District of Columbia have relaxed their marijuana standards, despite the federal government's reluctance.

The Coalition to Reschedule Cannabis petitioned the DEA in October 2002 to reschedule marijuana as a Schedule III, IV or V drug, saying the strict Schedule I label was inappropriate because marijuana has an accepted medical use in the United States.

In July 2011, after substantial evaluation by the Department of Health and Human Services, the DEA denied the petition to reschedule, finding that “the limited existing clinical evidence is not adequate to warrant rescheduling of marijuana under the CSA.”

Later that month, petitioners filed a petition for review of the DEA’s decision, arguing that it had acted arbitrarily and capriciously when it said marijuana lacks an accepted medical use and has a high potential for abuse.

A representative for the DEA was not immediately available for comment Friday.

The petitioners are represented by in-house counsel Joseph D. Elford.

The case is Americans for Safe Access et al. v. Drug Enforcement Administration, case number 13-84, in the U.S. Supreme Court.

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