Fwiw: DEA makes FDA approval of marijuana virtually impossible

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From mpp.org in case anyone is interested

DEA makes FDA approval of marijuana virtually impossible

Dear Friend:After three-and-a-half years of waiting, the DEA has blocked the onlyproposed research project that could lead to FDA approval of marijuanaas a prescription medicine.Please read on to find out why this ostensibly bad news actuallyprovides a big boost to the Marijuana Policy Project's efforts to passfederal- and state-level medical marijuana legislation ... as well asa boost to the medical marijuana case before the U.S. Supreme Court.On December 10, the DEA announced its rejection of a 2001 Universityof Massachusetts at Amherst application to establish a facility toproduce marijuana for FDA-approved research.Please visit http://www.mpp.org/states/site/quicknews.cgi?key=824 andhttp://mpp.org/USA/news_786.html to read the news coverage.Currently, there is only one source of marijuana that can be used inFDA-approved research -- the marijuana produced by the University ofMississippi for the federal government's National Institute on DrugAbuse. Significantly, this marijuana cannot be the marijuana that ismoved through the FDA approval process, because prescription medicinescannot be government-owned ... which is why researchers have beentrying for years to gain approval to produce a private supply ofmarijuana that can be tested, reproduced, studied in clinical trials,and ultimately approved by the FDA as a prescription medicine.In rejecting the researchers' application, the DEA stated that itwould allow only one source of marijuana in the U.S. -- the federalgovernment's supply in Mississippi -- which makes it impossible thatthe FDA could ever approve marijuana as a prescription medicine. And, just in case there is any doubt about the DEA's intent to blockresearch, the DEA's letter goes on to say this: "Current marijuanaresearch has not progressed to Phase 2 of the clinical trials becausecurrent research must use smoked marijuana, which ultimately cannot bethe permitted delivery system for any potential marijuana medicationdue to the deleterious effects and the difficulty in monitoring theefficaciousness of smoked marijuana." Incredibly, the DEA is declaringthat the FDA cannot approve marijuana before Phase 2 and Phase 3clinical trials are even completed (not that they even can be startedwith a private supply of marijuana). Visithttp://www.mpp.org/pdf/DEA.pdf to download the letter.In other words, the DEA has proven that the system is rigged to ensurethat the FDA can never approve marijuana as a prescription medicine,because the DEA can always block the research that the FDA requires.While the DEA's action is a setback for the effort to make marijuanaavailable as a prescription medicine through the FDA approval process,it actually boosts MPP's efforts to remove penalties for medicalmarijuana through the legislative process ... and may help win themedical marijuana case before the U.S. Supreme Court.In the Supreme Court three weeks ago, Justice Breyer suggestedthat patients should go to the FDA to get marijuana approved as amedicine, but now the DEA has slammed the door on that possibility.By taking the hard-line position it has, the DEA has just eliminatedour opponents' most effective and often-used argument against ourfederal and state-level medical marijuana bills -- that marijuanashould move through the FDA approval process and therefore weshouldn't be trying to use the legislative process. Now that FDAapproval is impossible, it blows apart our opponents' argument. MPP ismaking sure that all members of Congress and all state legislatorsnationwide hear this message loud and clear.In sum, since the DEA's decision means the only way to protectpatients from arrest is through state and federal legislation, ourefforts in both Congress and the states are even more urgent.MPP will be using the DEA's announcement to propel the various medicalmarijuana bills through the legislatures of Connecticut, Illinois,Minnesota, New York, and Rhode Island. Please visithttp://www.mpp.org/donate1095 to help us fund these campaigns.Thank you, as always, for your support.Sincerely,Rob KampiaExecutive DirectorMarijuana Policy ProjectWashington, D.C.