FDA dubious over medical marijuana
By: Jean Chemnick
published on 9 May, 2007
Such a negative vibe is a real bummer.
The recognition that St. Pierre and other cannabis activists have been waiting for came on April 19, during a markup of a drug safety bill in the Senate Health, Education, Labor and Pensions Committee. An amendment by Tom Coburn (R-Okla.) was adopted that required marijuana to undergo the same Food and Drug Administration approval process that other prescription drugs do.
Until this process is accomplished — and it typically takes about five years — those in the medical marijuana business apprehended by federal authorities could face penalties for violating FDA regulations as well as selling an illegal substance, even where state laws sanction the use. The activists say the conservative senator clearly intended to shut down medical marijuana cooperatives; California alone has about 450 of them, St. Pierre said.
Steph Sherer, founder and executive director of Americans for Safe Access, which advocates for medical marijuana only, said her group learned of Coburn’s amendment the night before the markup.
Her staff called members of the panel to try to dissuade them from approving the amendment, and she said everyone they talked to voted against it. She’s hopeful that Tom Harkin (D-Iowa) and Jeff Bingaman (D-N.M.), who voted with Republicans for the amendment, will change their minds.
Karen Woodson, ASA’s director of government affairs, said Coburn’s amendment is about prohibition, not regulation. The tests necessary to secure FDA approval would be impossible to conduct, she explained, because the Drug Enforcement Administration and the National Institute for Drug Abuse don’t give researchers permission to grow marijuana.
Nor can they use plants grown illegally. A NIDA spokeswoman said she could not answer questions about whether researchers would be able to obtain NIDA marijuana for drug approval purposes.
The only legal marijuana plants in the country are at the University of Mississippi, which has been growing cannabis since the 1960s, initially for the National Institute of Mental Health and now for NIDA. But Ole Miss typically does not sell its weed for tests of the drug’s effectiveness, Sherer said.
Allen St. Pierre is bumming right now. The term “medical marijuana” finally made its way into proposed legislation in the Senate. But, the executive director of the National Organization for the Reform of Marijuana Laws points out, if it becomes law, there will be even more barriers to the drug’s use, even in the 12 states where it’s legal.
Other research institutions have tried to get permission for prescription drug studies. Lyle Craker, a professor at the University of Massachusetts, Amherst, has been suing the federal government for three years for that right.
In February, an administrative law judge who hears DEA regulatory cases ruled “there is currently an inadequate supply of marijuana available for research purposes” and recommended that Craker’s application be granted. If the DEA disagrees, the decision probably would be appealed to a federal court.
St. Pierre, Sherer and other coalition members like the Marijuana Policy Project all say they’d welcome the chance to provide evidence of marijuana’s therapeutic effectiveness.
Sherer herself uses a marijuana tincture to treat pain from an old neck injury after her doctor found that conventional pain killers were hurting her kidneys.
To Coburn’s office, the time for studying is over. Roland Foster, a legislative assistant for the senator, said the FDA itself conducted a program that was terminated in the early ’90s because it determined that marijuana was not effective and might even harm patients.
“The FDA doesn’t need to conduct new tests to evaluate a drug that has been studied extensively for decades,” Coburn spokesman John Hart wrote in an e-mail.
However, the issue isn’t totally spent. Aides to the two Democrats who supported Coburn’s measure said they were unaware of any legal barriers to the licensing of marijuana.
Jennifer Mullin, a spokeswoman for Harkin, said he would welcome questions about licensing as part of the debate on the floor, and Jude McCartin, a spokeswoman for Bingaman, said the senator would consider supporting changes to the provision if licensing was indeed a barrier to the FDA approval process.
“Nothing would make me personally happier than having to put a label on cannabis and sell it,” St. Pierre said. “Boohoo.”
Washington D.C.’s Politico published an article entitled “FDA dubious over medical marijuana” that describes MAPS’ efforts to establish an independent supply of research-grade marijuana as a prerequisite to MAPS-sponsored FDA clinical trials, and how this relates to Senator Coburn’s recent medical marijauana legislation.