Compassionate Investigational New Drug program

The Compassionate Investigational New Drug program, or Compassionate IND, is a United States Federal Government-run Investigational New Drug program established in 1978 that allows a limited number of patients to use medical marijuana grown at the University of Mississippi. It is administered by the National Institute on Drug Abuse. Closed to new entrants, there are four known surviving patients who were grandfathered into the program.

The origins of the Compassionate Investigational New Drug Study program began after Robert C. Randall brought a lawsuit (Randall v. U.S) against the Food and Drug Administration, the Drug Enforcement Administration, the National Institute on Drug Abuse, the Department of Justice, and the Department of Health, Education & Welfare. 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 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.

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