Judge Submits Official Recommendation to DEA Urging End to 40-Year Barrier to FDA-Approved Medical Marijuana Research
WASHINGTON D.C. – A U.S. Department of Justice-appointed judge submitted her final recommendation to the U.S. Drug Enforcement Administration (DEA) on May 15, calling on the agency to end a forty-year government monopoly on the supply of research-grade marijuana available for Food and Drug Administration (FDA)-approved studies. With this monopoly broken, new studies could lead to medical marijuana’s availability in pharmacies as a legal, prescription drug. DEA Deputy Administrator Michele Leonhart must now accept the judge’s recommendation in order for the ruling to take effect, though she has no deadline for doing so and may choose to reject the recommendation.
“Medical marijuana is one step away from the FDA
development process, where it should be. Science, not politics, needs to
determine whether medical marijuana should be made legal, and the DEA has so far
tried to block the scientific process,” said University of Massachusetts-Amherst
Professor Lyle Craker, who six years ago petitioned DEA for a license to grow
research-grade marijuana for use in privately-funded, FDA-approved studies that
aim to develop the plant into a legal, prescription medicine. “I hope that the
Deputy Administrator acts quickly to allow this critical research to move
forward.”
On May 15, DEA Administrative Law Judge Mary Ellen
Bittner submitted her recommendation to the DEA’s Deputy Administrator in which
she found that it is “in the public interest” to end the federal monopoly on the
supply of marijuana that can be used in FDA-approved research, held by the
National Institute on Drug Abuse (NIDA).
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, “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.” She added, “Respondent’s registration to
cultivate marijuana would be in the public
interest.”
The American Civil Liberties Union (ACLU) represents
Craker in the proceedings, and pointed to the groundswell of support for medical
research and calls for marijuana to go through the FDA development process
without delay to determine whether it could be made available to patients in
pharmacies.
“The DEA has forced patients to get their medicine from
the street corner instead of from pharmacies by blocking the very research that
would put the medical marijuana issue through proper regulatory channels,” said
Allen Hopper, legal director of the ACLU Drug Law Reform Project. “The time has come for the government
to stop putting politics before science and to allow the research, not the
politicians, to decide whether medical marijuana should be made legal.”
Legal papers filed throughout the proceedings pointed to
the fact that marijuana is the only Schedule I drug the 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.
In contrast, NIDA has remained scientists’ sole source
of marijuana, despite the agency’s repeated refusal to make marijuana available
for privately-funded, FDA-approved research that seeks to develop smoked or
vaporized marijuana into a legal, prescription medicine. During the legal
proceedings, the ACLU and others argued that such research conflicts with NIDA’s
core mission, which is to study the harmful, not potentially medicinal, 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. “Judge Bittner’s recommendation marks a shift in this debate. I look
forward to facilitating for marijuana the same rigorous, scientific research
required to bring all other prescription medicines to
market.”
Thirty-eight 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 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.
Despite federal prohibition, 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.
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.
Judge Bittner’s final recommendation in support of
Professor Craker’s petition is available at: www.aclu.org/drugpolicy/medmarijuana/28341lgl20070212.html.
Audio of the ACLU's Hopper's statement during a teleconference held today can be heard at: www.aclu.org/drugpolicy/medmarijuana/29856res20070523.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.