Medical Marijuana One Step Away from FDA Development Process

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.