Mid-July 1994 – Assistant Secretary of Health Announces Final Decision Not to Reopen IND Compassionate Use Medical Marijuana Program

“As you may recall, in 1992, the Assistant Secretary of Health in the Bush Administration, Dr. James Mason, shut down the FDA’s Single Patient IND Program (Compassionate Access) for medical marijuana patients because it was growing too large, too visible, too expensive and too time- consuming for the FDA to administer. Over the course of the last year, the current Assistant Secretary of Health, Dr. Philip Lee, has been pressed by various congresspeople to review Dr. Mason’s decision. In a letter sent in mid-July to Representative Barney Frank and the other congresspeople and senators who contacted him about this issue, Dr. Lee announced that he has finally reached a decision concerning his course of action… Dr. Lee indicated that he has decided not to reopen the Compassionate Access Program. According to Dr. Lee, the fatal flaw of that program was that it did not generate data that could be submitted to the FDA to either support or reject the hypothesis that smoked marijuana had a safe and efficacious medical use. Dr. Lee did not offer any government funds for research, yet indicated that only FDA-approved research could resolve this controversy.”