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Date: July 29, 1997
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION, Donald McLearn:(301) 443­1130, Broadcast Media: (301) 827­3434, Consumer Hotline: (800) 532­4440 

FDA Seeks Public Comment on Informed Consent Rules in Combat Situations

The agency's notice, published in Federal Register, focuses on FDA's interim final rule and issues about its use that have been raised since the Persian Gulf War.

FDA's interim final rule, issued in December 1990, authorized the Commissioner of Food and Drugs to determine whether obtaining informed consent from military personnel for the use of an investigational medication is not feasible under combat conditions. The agency subsequently permitted during the Operation Desert Storm informed consent waivers for the use of two investigational products, pyridostigmine bromide and botulinum toxoid vaccine, to potentially protect U. S. troops against chemical and biological warfare.

Because of the lethal nature of the chemical and biological warfare agents against which the two medications were expected to provide some protection, it was not possible to test either investigational product for safety and effectiveness in the usual manner.

Based on trials in animals, however, the two investigational medications at the time appeared to offer the best available protection against the toxic chemical and biological agents anticipated to be in the Iraqi military arsenal. Both medications were used on a limited scale during the war.

The use of the investigational drugs by DOD and the FDA rule were among the subjects studied by the Presidential Advisory Committee on Gulf War Veterans' Illnesses. Last year, the Advisory Committee issued an interim report that described a number of difficulties in DOD's application of FDA's rule, including the issue of disclosure to service personnel; problems in record keeping; lack of long­term follow up of individuals who received the investigational products; and lack of review by an Institutional Review Board outside DOD.

Among other recommendations, the Committee suggested that FDA should re­examine its interim rule by submitting it for public comment.

FDA is today soliciting written comments on specific questions covering three broad areas. In general, the agency wants to know the public's and outside experts' views on a number of issues, including:

• whether it should revoke or amend the interim rule of December 1990 and if the latter, whether and how it could be amended;
• when is it ethical to expose volunteers to toxic chemical and biological agents to test the effectiveness of products that may be used to provide potential protection against those agents; and
• if products that may be used for protection against toxic substances cannot be ethically tested in humans, what evidence would be needed to adequately demonstrate their safety and effectiveness.