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August 22, 1980

FDA ponders wider distribution of THC

JAMA. 1980;244(8):754. doi:10.1001/jama.1980.03310080008003

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The Food and Drug Administration is expected to act soon on a recommendation that Δ9-tetrahydrocannabinol (THC)—which is found in marijuana—be made available through cancer investigators for treatment of nausea and vomiting in approximately 50,000 patients undergoing chemotherapy.

The FDA's Oncologic Drugs Advisory Committee voted 5 to 4 on June 26 to recommend the wider distribution. Under the proposal, THC would remain "investigational," and distribution through hospital pharmacies would be monitored by the US Department of Justice's Drug Enforcement Administration. While several pharmaceutical companies have discussed submission of a new drug application for THC or a synthetic version, none has done so, and THC remains "investigational" until such an application is approved.

The chemical's potential for combating nausea in cancer chemotherapy patients has been under study since the early 1970s, as have other aspects of its use (JAMA [MEDICAL NEWS] 243:15-18, 1980). The National Cancer Institute, Bethesda, Md, estimates