nated in the initial FDA approval of Marinol in 1985 were conducted or funded by the National Cancer Institute beginning in the 1970s. Unimed estimates that it contributed only about onequarter of the total research effort that secured Marinol's entry into the U.S. market. Its development also proceeded more quickly than usual, moving from IND to approval in two years, compared with five years for the average drug.
Unimed later applied for FDA approval to market Marinol for a second indication—AIDS wasting. At that time, the agency required Unimed to complete two relatively small Phase III studies, which lasted three years and cost approximately $5 million—again, a relative bargain in terms of both time and money. Under the Orphan Drug Act, the FDA also granted Marinol seven years of exclusive marketing for this application, beginning with its approval in 1992.
After Marinol received FDA approval for AIDS wasting in 1992, its sales grew significantly. This gain was especially welcome, since profits from medication for chemotherapy-induced nausea were beginning to decline as a result of the introduction of more effective antinausea drugs, such as ondansetron, that are also unscheduled.
Since its commercial introduction in 1985, Marinol had been listed in the most restrictive schedule for medically useful controlled substances along with morphine, cocaine, and other prescription medications with a “high potential for abuse.” While such a distinction clearly limited Marinol's availability, it did not delay the drug's initial entry into the market because the scheduling decision was made by the DEA prior to FDA approval; nor did any delays occur as a result of state scheduling laws.
When Unimed later prepared to petition the DEA to reschedule Marinol, the company commissioned a study to determine the extent to which its product was being abused. The study was conducted by researchers at the Haight Ashbury Free Clinic in San Francisco—where significant numbers of marijuana users, as well as people with HIV and AIDS, receive treatment—and it included information gathered from addiction medicine specialists, oncologists, cancer and AIDS researchers, and law enforcement officials.2 The researchers reported that they found no evidence that Marinol was being abused or diverted from medical use.