FDA Basics: Kathleen Uhl, MD on the FDA’s Office of Women’s Health

FDA Basics: Kathleen Uhl, MD on the FDA’s Office of Women’s Health


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.

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