FDA
TALK PAPER

T97-46                        Susan M. Cruzan:  301-827-6242  
Sept. 23, 1997                
                              Consumer Hotline: 800-532-4440


          FDA PROPOSES RULE ON WOMEN IN CLINICAL TRIALS

     FDA today proposed a rule that would ensure that women are
not excluded from participating in early studies of drugs and
biologics to treat life-threatening diseases just because of
their reproductive potential.  The following may be used to
respond to inquiries.
     In a notice to be published in tomorrow's Federal Register,
the agency is requesting public comment on a proposal that would
prevent the routine exclusion of either men or women from
clinical studies because of potential risks of toxicity to
offspring or reproductive organs.  
     The proposed rule would permit FDA to place a trial on
clinical hold (not allow the study to be conducted or to
continue) if a sponsor proposes to exclude or is excluding women
from a trial for inappropriate reasons. 
     FDA's proposal reflects a significant evolution of thought
about participation of women of reproductive potential in
clinical studies during the past two decades, and is in keeping
with the agency's l993 guideline encouraging women's
participation in all phases of clinical trials.  
     FDA prepared this proposal after the National Task Force on
AIDS Drug Development and the Presidential Advisory Council on
HIV/AIDS recommended that women with HIV or AIDS, particularly
those of reproductive potential, not be excluded from
investigational trials intended to study a therapy for a 
life-threatening disease.
Many of the women who are affected by HIV and AIDS are young women
 with reproductive potential.  
     The council's recommendation, along with limited surveys of
some applications showing the exclusion of women of reproductive
age in some clinical trials, including some trials of drugs for
life-threatening illness, led to today's proposal.  
     In developing this proposal FDA focused on several important
factors:
     First, FDA is committed to expanding access to and
accelerating approval of new therapies for life-threatening
diseases.  FDA recognizes that physicians and patients are
generally willing to accept greater potential risks or side
effects from medical products to treat life-threatening diseases. 
     Second, FDA believes that patients, including women of
reproductive potential, in concert with their partners and
doctors, can make their own risk/benefit decision when provided
with thorough information about risks and potential benefits by
the clinical investigator.  The informed consent process,
required by law for participation in all studies, provides
information intended to describe known and potential risks,
including potential risks to the embryo or fetus, should a woman
become pregnant.   
     By encouraging diversity at all stages of a drug's
development, FDA hopes that drug sponsors will generate better
data about how the drug will affect the populations that will
receive it once it is marketed.  The agency believes it is
important to identify important information about a drug during
the investigational phase, such as dosages for different age
groups, genders, and racial subgroups, and to use that
information to refine labeling information, patient selection,
and dose selection. 
     It is important to note that the proposed rule would not
require specific recruitment goals for women, nor would it apply
to all clinical trials.  For example, it would not apply to:
-- Clinical trials designed to look at healthy volunteers
exclusively;
--trials designed to test drugs for special circumstances, such
as in gender specific populations such as drugs for prostate
cancer; or
-- trials designed exclusively for men so long as a companion
study in women of reproductive potential has been planned or is
being conducted.
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