Prescription Pot; the FDA seems open to the idea of medical marijuana.

• Author: Sullum, Jacob
• Position: Food and Drug Administration - Trends

A PHARMACEUTICAL COMPANY TYPIcally spends some $230 million and a decade or longer to win approval from the Food and Drug Administration for a new medicine. But Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS), expects to complete the process within two years at a cost of about $500,000. To be sure, the drug he has in mind--marijuana--is not exactly new.

Encouraged by the FDA's 1992 approval of MDMA research with human subjects (see Trends, February 1993), Doblin asked the agency's Pilot Drug Evaluation Staff what it would take to make marijuana available by prescription. With the FDA's guidance, MAPS developed a research plan, including a large, multi-site clinical study and a series of individual trials, to test marijuana's effectiveness in treating AIDS wasting syndrome. In October the FDA approved a protocol for the large study, to be supervised by Donald Abrams, research director of the San Francisco Community Consortium, which coordinates AIDS research in the Bay Area.

Doblin says the protocol was submitted, revised, and approved within a week. "The FDA has expedited this," he says. "The FDA is being extremely helpful." He attributes what he calls "a monumental shift at the FDA" to the waning of the drug war and the influence of Commissioner David Kessler. He says Kessler seems sympathetic...