On Eve of Obama Presidency, DEA Blocks Privately-Funded, FDA-Approved Medical Marijuana Research
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WASHINGTON, D.C. - The Bush administration struck a parting shot to legitimate science today as the Drug Enforcement Administration (DEA) refused to end the unique government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-approved research. DEA’s final ruling rejected the formal recommendation of DEA Administrative Law Judge (ALJ) Mary Ellen Bittner, issued nearly two years ago following extensive legal hearings.
"With one foot out the door, the Bush administration has once again found time to undermine scientific freedom," said Allen Hopper, litigation director of the American Civil Liberties Union Drug Law Reform Project. "In stubbornly retaining the unique government monopoly over the supply of research marijuana over the objections of DEA’s own administrative law judge, the Bush administration has effectively blocked the proper regulatory channels that would allow the drug to become a wholly legitimate prescription medication."
The DEA ruling constitutes a formal rejection of University of Massachusetts at Amherst Professor Lyle Craker’s petition, filed initially June 24, 2001, to cultivate research-grade marijuana for use by scientists in FDA-approved studies aimed at developing the drug as a legal, prescription medication.
The ACLU and Julie Carpenter of the Washington, D.C. law firm Jenner & Block represent Professor Craker in the proceedings.
Professor Craker’s petition was rejected despite the opinion of DEA ALJ Bittner that granting Craker a license to grow marijuana "would be in the public interest." Judge Bittner issued a comprehensive, 88-page nonbinding recommendation to DEA Deputy Administrator Michele Leonhartt on February 12, 2007, following nine days of hearings, testimony and evidence presented by the ACLU and others on both sides of the issue.
DEA failed to take action on Judge Bittner’s recommendation until now, continuing the strategy of delay and pattern of unresponsiveness that has characterized the process since Professor Craker first filed his initial petition seven-and-a-half years ago.
"I am saddened that the DEA is ignoring the best interests of so many seriously ill people who wish for scientific investigations that could lead to development of the marijuana plant as a prescription medicine," said Professor Craker. "Patients with serious illnesses deserve legitimate research that might establish medical marijuana as a fully legal, FDA-approved treatment. Today, that effort has been dealt a serious blow."
Judge Bittner’s recommendation was based largely on the fact that marijuana is the only Schedule I drug that the DEA prohibits from being produced by private laboratories for scientific research, which has resulted in a unique government monopoly that fundamentally obstructs appropriate research and regulatory channels. Other controlled substances, including LSD, MDMA, heroin and cocaine, are available to researchers from DEA-licensed private laboratories.
In contrast, the National Institute on Drug Abuse (NIDA) remains scientists’ sole source of marijuana, despite the agency’s repeated refusal to make marijuana available for privately-funded, FDA-approved studies that seek to develop smoked or vaporized marijuana into a legal, prescription medicine.
As Judge Bittner concluded, "NIDA’s system for evaluating requests for marijuana has resulted in some researchers who hold DEA registrations and requisite approval from [HHS and FDA] being unable to conduct their research because NIDA has refused to provide them with marijuana. I therefore find that the existing supply is not adequate."
Professor Craker’s proposed facility to grow high-quality medical marijuana for research purposes would 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.
"The DEA and NIDA, but not the FDA, are clearly frightened of permitting privately-funded, scientific research into the risks and benefits of the medical uses of marijuana," said Rick Doblin, President of MAPS. "We need the Obama Administration to reverse this egregious suppression of scientific research that the outgoing administration so fears will reveal inconvenient truths."
Forty-five members of the U.S. House of Representatives, Massachusetts Senators John Kerry (D-MA) and Edward Kennedy (D-MA), and a broad range of scientific, medical and public health organizations have written in support of Professor Craker, including 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.
Despite contradictory federal policy, 13 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.
Judge Bittner’s final recommendation in support of Professor Craker’s petition is available at: www.aclu.org/drugpolicy/medmarijuana/28341lgl20070212.html
The DEA’s rejection of Professor Craker’s petition is available at: www.aclu.org/drugpolicy/medmarijuana/38298lgl20090112.html
Complete background on the case, including client profiles, hearing transcripts, a full selection of legal documents, media reports, and letters of support from lawmakers and scientists can be found at: www.aclu.org/drugpolicy/medicalmarijuanafeature/index.html and www.maps.org/mmj/DEAlawsuit.html