NEWS
09/21/1995

<TITLE> FDA ANNOUNCES INFORMED CONSENT PROPOSALS FOR EXPERIMENTAL
THERAPIES </TITLE>








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<PRE>

P95-7                                Food and Drug Administration
FOR IMMEDIATE RELEASE                Betsy Adams (301) 443-3285
September 21, 1995                    

FDA ANNOUNCES INFORMED CONSENT PROPOSALS FOR EXPERIMENTAL THERAPIES
     The Food and Drug Administration today proposed ways to make
it easier for drugs and medical devices to be studied in patients
who are in life-threatening situations and unable to give informed
consent for their use.  
     The proposals are designed both to clarify the rules for the
testing of unapproved drugs and devices that may save lives and
also provide safeguards for patients.  
     "It's essential to protect patients, and it's also important
to give them a chance to use new therapies," said Health and Human
Services Secretary Donna E. Shalala.  "The proposals accomplish
both.  They also have broad support from industry, medical and
consumer groups."  
     "The proposed rules will enable us to get the information we
need to approve new and better therapies for use in emergency
medicine," said FDA Commissioner David A. Kessler, M.D.  "It is
important that in emergency situations health care professionals
have access to the tools that will be most beneficial to their
patients."
                             -More-                                   Page 2, P95-7, Informed Consent
     Emergency-use products often have to be used in situations
when the patient is unconscious and there is no time to locate a 
legal representative authorized to give consent for the use of an
unapproved device or medicine.  As a result, these patients are
being denied the benefits of a promising new therapy, and some
studies involving emergency-use products are encountering problems
in enrolling patients in clinical trials.
     The proposals address the issue of informed consent by
providing that an independent physician and a hospital's
institutional review board -- a committee of experts and lay
persons currently established to review research -- must agree that
the trial addresses a life-threatening situation and that other
criteria are met.  
     The regulations would apply under these conditions:  
     * patients are in a life-threatening situation
     * available treatments are unproven or unsatisfactory
     * research is necessary to determine what intervention is best
     * research could not be conducted otherwise
     * informed consent is not feasible because a patient cannot
consent due to a medical condition, intervention must be done
before consent from a patient's representative is feasible, and
consent cannot be obtained in advance because prospective subjects
cannot reliably be identified ahead of time
                             -More-
                                   Page 3, P95-7, Informed Consent
     * risks and benefits of the experimental treatment are
reasonable in light of what is known about the condition and risks
and benefits of other therapies    
     Also, additional protections will be provided to patients. 
These protections include consulting with the community, public
disclosure of the study design and attendant risks prior to its
commencement, public disclosure of study results when completed,
use of an independent data and safety monitoring board, and others
as appropriate.
     An approved informed consent document would have to be
available for use in cases where informed consent from the patient
or a representative can be obtained.  In addition, patients or
their representatives would have to be informed about the study as
soon as possible and told that the patient may withdraw from the
study, or be withdrawn by the representative, without penalty.    
     The proposed regulations are being published in the Federal
Register on Sept. 21.  Comments must be received within 45 days 
and should be sent to Dockets Management Branch (HFA-305), Food and
Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville,
Md.  20857.
     FDA is a Public Health Service agency in HHS. 
                           ####         
</PRE>





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