(1976) Robert Randall - The First Federal US Legal Medical Marijuana User The
Compassionate Investigational New Drug program, or Compassionate IND, is the Investigational New Drug program allowing a limited number of patients to use National Institute on Drug Abuse-provided medical marijuana grown at the University of Mississippi. Closed to new entrants, there are only seven surviving patients who were grandfathered into the program.
The Compassionate Investigational New Drug Study program began in 1978 after a lawsuit was brought against the Food and Drug Administration, Drug Enforcement Administration, National Institute on Drug Abuse, Department of Justice, and the Department of Health, Education & Welfare by Robert Randall (Randall v. U.S). In 1976, Randall, afflicted with glaucoma, had successfully used the Common Law doctrine of necessity to argue against charges of marijuana cultivation because it was deemed a medical necessity (U.S. v. Randall). On November 24, 1976, federal Judge James Washington ruled:
While blindness was shown by competent medical testimony to be the otherwise inevitable result of the defendant's disease, no adverse effects from the smoking of marijuana have been demonstrated. Medical evidence suggests that the medical prohibition is not well-founded.
The criminal charges against Randall were dropped, and following a petition (May 1976) filed by Randall, federal agencies began providing him with FDA-approved access to government supplies of medical marijuana, becoming the first American to receive marijuana for the treatment of a medical disorder. Randall went public with his victory and shortly after the government tried to prevent his legal access to marijuana. This led to the aforementioned 1978 lawsuit where Randall was represented pro bono publico by law firm Steptoe & Johnson. Twenty-four hours after filing the suit, the federal agencies requested an out-of-court settlement which resulted in Randall gaining prescriptive access to marijuana through a federal pharmacy near his home.
The settlement in Randall v. U.S. became the legal basis for the FDA's Compassionate IND program. Initially only available to patients afflicted by marijuana-responsive disorders and orphan drugs, the concept was expanded to include HIV-positive patients in the mid-1980s. Due to the growing number of AIDS patients throughout the late 1980s and the resulting numbers of patients who joined the Compassionate IND program, the George H. W. Bush administration closed the program down in 1992. At its peak, the program had thirty active patients.
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