THE HISTORY OF THE INTERIM RULE
The history of the Interim Rule involves the discussions that led to its promulgation ; the immediate, but limited, controversy surrounding it; and the FDA decision seven years after the Gulf War to complete the rule-making process. The brief text of the Interim Rule was provided at the end of Chapter One. Its main provisions are these: A process is established by which a determination may be made by the Commissioner of Food and Drugs, pursuant to a written request by the Assistant Secretary of Defense (Health Affairs) (ASD[HA]), that obtaining informed consent for the use of investigational drugs is "not feasible" for a "specific military operation involving combat or the immediate threat of combat." The request must indicate that a duly constituted IRB has reviewed and approved the use of the IND without informed consent. The commissioner, in reaching his or her decision, may find that obtaining informed consent is not feasible "only when withholding treatment would be contrary to the best interests of the military personnel" and when "no available satisfactory alternative therapy" is available.
A Memorandum of Understanding (MOU) has existed between DoD and FDA for some time that pertains to the "investigational use of drugs, antibiotics, biologics, and medical devices" by DoD (52 FR 33472, September 3, 1987). 1 It provides that clinical testing of investigational drugs, biologics, or medical devices under programs sponsored by DoD, whether conducted within DoD facilities or by a contractor or grantee, will follow FDA regulations governing____________________