HHS NEWS

P97-22                        FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE         Donald McLearn:   (301) 827-6242

July 29, 1997                 

                              Consumer Hotline: (800) 532-4440 



                              

       FDA SEEKS PUBLIC COMMENT ON INFORMED CONSENT RULES 

                       IN COMBAT SITUATIONS



     The Food and Drug Administration today invited comment on

significant ethical and regulatory issues involved in the waiving

of informed consent for the use of investigational medications

for troops engaged 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 long-term 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 re-examine 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.

     Written comments may be submitted until October 30, 1997 to

Dockets Management Branch, HFA-305, Food and Drug Administration,

12420 Parklawn Drive, room 1-23, Rockville, MD 20857.  After

evaluating the responses, FDA will publish a proposal for

appropriate action.

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