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And what does the FDA's Office of
Women's Health do?
The office has essentially two functions.
One function is an outreach function where we
develop and disseminate consumer health information
for women and their families as it relates to FDA
regulated products.
And then our other program is a research and
development program where the program funds
scientists inside the agency to study the safety
and efficacy of medical products as they relate to
the health of women.
And in addition to that, we have a program within
our own office that--we have our own individual
scientific projects where we look at the
participation of women in clinical studies.
And that's really key too,
to a lot of the work that the FDA does,
to make sure the clinical trials
are properly represented correct?
That's correct.
And our office was established in 1994 by a
congressional mandate because of concerns that
women were inadequately being represented in
clinical studies.
And so the mission of our office is to advocate for
the appropriate representation of women in
clinical studies.
So part of your work is being an advocate?
Yes, part of our work is being an
advocate for women and for their families.
That may be a little unusual for a
regulatory agency, but not unusual for a public
health agency like the FDA.
Absolutely.
Actually, it makes our office very unique within
a regulatory agency, that we have a very strong
advocacy role.
But FDA is a consumer protection agency and our
office does just that.
You're also a physician and you see
patients.
Is that important to your work?
Yes, I see patients at Walter Reed.
And I think it's very important to my work.
As a physician at FDA, I think it's important to
see how the products that the agency regulates are
used on a day to day basis by the health care
community.
So, you can see it from
the regulatory point of view
and also the practicing physician
point of view,
and that's important at both ends I would guess.
Yes, I think it's important at both ends
and I'm glad to be afforded the opportunity
to still keep my finger in clinical medicine while
being at the agency.
Thank you very much.
You are very welcome.