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WASHINGTON – The American Civil Liberties Union applauded a ruling issued by an U.S. Drug Enforcement Administration judge that recommends ending the federal government’s sixty-five year monopoly on the supply of marijuana available for Food and Drug Administration-approved medical research.
The ACLU represents University of Massachusetts-Amherst Professor Lyle Craker, who petitioned the Drug Enforcement Administration (DEA) for a license to grow research-grade marijuana for use in privately-funded studies that aim to develop the plant into a legal, prescription medicine. The DEA judge ruled that it is in the public interest to end the federal National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana that can be used in Food and Drug Administration (FDA)-approved research.
"For too long the DEA has inappropriately inserted politics into a regulatory process that should be left to the FDA and medical science," said Allen Hopper, an attorney with the ACLU Drug Law Reform Project. "We are pleased that the judge has recommended an end to the federal government’s blockade of medical marijuana research."
The DEA must now either accept or reject the court’s recommendation, and scientists, doctors and medical marijuana patients nationwide joined the ACLU in urging the agency to comply with the court’s finding and halt federal obstruction of medical marijuana research.
"This ruling is a victory for science, medicine and the public good," said Professor Craker. "I hope that the DEA abides by the decision and allows the work to go forward unimpeded by drug war politics."
The ruling issued yesterday by U.S. Department of Justice-appointed Administrative Law Judge Mary Ellen Bittner marks a major step forward in the six year struggle by Professor Craker to gain a DEA license to grow research-grade marijuana for use by other scientists in privately funded, government-approved studies.
Following nine days of hearings, testimony and evidence from both sides, including from researchers who reported that the government denied their requests for marijuana for use in FDA-approved research protocols, Judge Bittner concluded, "that there is currently an inadequate supply of marijuana available for research purposes…" and that, "Respondent’s registration to cultivate marijuana would be in the public interest."
Thirty-eight members of Congress and a broad range of scientific and medical organizations have joined Professor Craker in challenging the federal government’s policy of blocking administrative channels and obstructing research that could lead to the development of marijuana as a prescription medicine. These organizations include the Lymphoma Foundation of America, the National Association for Public Health Policy, the Multiple Sclerosis Foundation, as well as several state medical and nurses’ associations.
Marijuana is the only Schedule I drug that DEA has prohibited from being produced by private laboratories for scientific research. Other controlled substances, including LSD, MDMA (also known as "Ecstasy"), heroin and cocaine, are available to researchers from DEA-licensed private laboratories, such as the one Professor Craker plans to establish.
In contrast, NIDA has remained scientists’ sole source of marijuana, despite criticism over the agency’s refusal to make marijuana available for all FDA-approved research into the plant’s potential medical value. The ACLU and others point out that such research conflicts with NIDA’s mission to study the harmful effects of drugs of abuse. In addition, researchers report that marijuana available through NIDA is of low quality and variety and is not optimized to meet FDA standards for prescription drug development.
Professor Craker’s proposed facility to grow high-quality medical marijuana for research purposes will be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit pharmaceutical company with plans to develop marijuana into a fully legal, prescription medication.
"For decades, we’ve been told by the politicians that marijuana has no proven medical value while scientists have been denied the ability to prove otherwise," said Rick Doblin, Ph.D., president and founder of MAPS. "Hopefully, today’s decision marks a shift towards science, not politics, guiding medicine in America."
Despite federal prohibition, 12 states have enacted legislation protecting patients who use medical marijuana with a physician’s recommendation from prosecution under state law, and national polls consistently find that roughly 75 percent of Americans support the use of medical marijuana.
"Today’s ruling is an important step toward allowing medical marijuana patients to get their medicine from a pharmacy just like everyone else," added the ACLU’s Hopper. "That would clear up the controversies surrounding state medical marijuana laws."
The ACLU is co-counsel in the case, In the Matter of Lyle Craker, with Julie Carpenter at the Washington D.C. law firm Jenner & Block, LLP and is assisted by Steptoe & Johnson, LLP.
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