[Congressional Record Volume 147, Number 73 (Thursday, May 24, 2001)]
[Senate]
[Pages S5618-S5620]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Ms. SNOWE (for herself, Ms. Mikulski, and Mr. Harkin):
S. 946. A bill to establish an Office on Women's Health within the
Department of Health and Human Services; to the Committee on Health,
Education, Labor, and Pensions.
Ms. SNOWE. Mr. President, I rise today to introduce the Women's
Health Office Act of 2001 and I am pleased to be joined on this
legislation by my friends and colleagues Senators Mikulski and Harkin.
Companion legislation to this bill has been introduced in the House by
Congresswomen Connie Morella and Carolyn Maloney.
The Women's Health Office Act of 2001 provides permanent
authorization for Offices of Women's Health in five Federal agencies:
the Department of Health and Human Services, HHS; the Centers for
Disease Control and Prevention, CDC; the Agency for Health Care
Research and Quality, AHRQ; the Health Resources and Services
Administration, HRSA; and the Food and Drug Administration, FDA.
Currently, only two women's health offices in the Federal Government
have statutory authorization: the Office of Research on Women's Health
at the National Institutes of Health, NIH, and the Office for Women's
Services within the Substance Abuse and Mental Health Services
Administration, SAMHSA.
For too many years, women's health care needs were ignored or poorly
understood, and women were systematically excluded from important
health research. One famous medical study on breast cancer examined
hundreds of men. Another federally funded study examined the ability of
aspirin to prevent heart attacks in 20,000 medical doctors, all of whom
were men, despite the fact that heart disease is a leading cause of
death among women.
Today, Members of Congress and the American public understand the
importance of ensuring that both genders benefit equally from medical
research and health care services.
Throughout my tenure in the House and Senate, I have worked hard to
expose and eliminate this health care gender gap and improve women's
access to affordable, quality health services. As cochairs of the
Congressional Caucus for Women's Issues, CCWI, Representative Pat
Schroeder and I, along with Representative Henry Waxman, called for a
GAO investigation, in the beginning of 1990, into the inclusion of
women and minorities in medical research at the National Institutes of
Health.
This study documented the widespread exclusion of women from medical
research, and spurred the Caucus to introduce the first Women's Health
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Equity Act, WHEA, in 1990. This comprehensive legislation provided
Congress with its first broad, forward-looking health agenda designed
to redress the historical inequities that face women in medical
research, prevention and services.
Three years later, Congress enacted legislation mandating the
inclusion of women and minorities in clinical trials at NIH through the
National Institutes of Health Revitalization Act of 1993, P.L. 103-43.
Also included in the NIH Revitalization Act was language establishing
the NIH Office of Research on Women's Health, language based on my
original Office of Women's Health bill that was introduced in the 101st
Congress.
Yet, despite all the progress that we have made, there is still a
long way to go on women's health care issues. Last May, the GAO
released a report, a 10-year update, on the status of women's research
at NIH, ``NIH Has Increased Its Efforts to Include Women in Research''.
This report found that since the first GAO report and the 1993
legislation, NIH had made significant progress toward including women
as subjects in both intramural and external clinical trials.
However, the report noted that the Institute had made less progress
in implementing the requirement that certain clinical trials be
designed and carried out to permit valid analysis by sex, which could
reveal whether interventions affect women and men differently. The GAO
found that NIH researchers would include women in their trials--but
then they would either not do analysis on the basis of sex, or if no
difference was found, they would not publish the sex-based results.
NIH has done a good job of improving participation of women in
clinical trials and has implemented several changes to improve the
accuracy and performance for tracking and analyzing data, but our
commitment to women's health is not about quotas and numbers. It is
about real scientific advances that will improve our knowledge about
women's health. At a time when we are on track to double funding for
NIH, it is troubling that the agency has still failed to fully
implement both its own guidelines and the Congressional directive for
sex-based analysis. And as a result, women continue to be shortchanged
by Federal research efforts.
The crux of the matter is that NIH's problems exist despite that fact
that it has an Office of Women's Health that is codified in law. If NIH
is having problems, imagine the difficulties we will have in continuing
the focus on women's health in offices that do not have this
legislative mandate, and that may change focus with a new HHS Secretary
or Agency Director.
Offices of Women's Health across the Public Health Service are
charged with coordinating women's health activities and monitoring
progress on women's health issues within their respective agencies, and
they have been successful in making Federal programs and policies more
responsive to women's health issues. Unfortunately, all of the good
work these offices are doing is not guaranteed in Public Health Service
authorizing law. Providing statutory authorization for federal women's
health offices is a critical step in ensuring that women's health
research will continue to receive the attention it requires in future
years.
Codifying these offices of women's health is important for several
reasons. First, it re-emphasizes Congress's commitment to focusing on
women's health. Second, it ensures that agencies will enact
congressional intent with good faith. Finally, it ensures that
appropriations will be available in future years to fulfill these
commitments.
By statutorily creating Offices of Women's Health, the Deputy
Assistant Secretary for Women's Health will be able to better monitor
various Public Health Service agencies and advise them on scientific,
legal, ethical and policy issues. Agencies would establish a
Coordinating Committee on Women's Health to identify and prioritize
which women's health projects should be conducted. This will also
provide a mechanism for coordination within and across these agencies,
and with the private sector. But most importantly, this bill will
ensure the presence of offices dedicated to addressing the ongoing
needs and gaps in research, policy, programs, education and training in
women's health.
I urge my colleagues to join Senators Mikulski, Harkin, and me in
supporting this legislation to help ensure that women's health will
never again be a missing page in America's medical textbook.
Ms. MIKULSKI. Mr. President, I rise to join Senator Snowe and Senator
Harkin to introduce the Women's Health Office Act of 2001. I am pleased
to introduce this bill with my colleagues because it establishes an
important framework to address women's health within the Department of
Health and Human Services, HHS.
Historically, women's health needs have been ignored or inadequately
addressed by the medical establishment and the government. A 1990
General Accounting Office, GAO, report stated that: the National
Institutes of Health, NIH, had made little progress in implementing its
own inclusion policy on women's participation in clinical trials, NIH
inconsistently applied this policy, and NIH had done little to
implement analysis of research findings by gender. This was
unacceptable. Women make up half or more of the population and must be
adequately included in clinical research. That's why I fought to
establish the Office of Research on Women's Health, ORWH, at the NIH 11
years ago. We needed to ensure that women were included in clinical
research, so that we would know how treatments for a particular disease
or condition would affect women. Would men and women react the same way
to a particular treatment for heart disease? We can't answer this
question unless both men and women are being included in clinical
trials.
While the ORWH began its work in 1990, I wanted to ensure that it
stayed at NIH and had the necessary authority to carry out its mission,
part of which is to ensure that women are included in clinical
research. That's why I authored legislation in 1990 and 1991 to
formally establish the ORWH in the Office of the Director of NIH. These
provisions were later enacted into law in the NIH Revitalization Act of
1993.
In 1999, Senator Harkin, Senator Snowe, and I requested that GAO
examine how well the NIH and the ORWH were carrying out the mandates
under the NIH Revitalization Act of 1993. The results were mixed. While
NIH had made substantial progress in ensuring the inclusion of women in
clinical research, it had made less progress in encouraging the
analysis of study findings by sex. This means that women are being
included in clinical trials, but we are not able to fully reap the
benefits of inclusion if the analysis of how interventions affect men
and women is not being done or not being reported. While the NIH and
others are taking steps to address this, we may be missing information
from research done over the last few years about how the outcomes
varied or not for men and women.
NIH is but one agency in HHS. Other agencies in HHS do not even have
women's health offices. How are these other agencies addressing women's
health? Only NIH and the Substance Abuse and Mental Health Services
Administration, SAMHSA, have authorizations in law for offices
dedicated to women's health. In 1993, I requested language that
accompanied the Fiscal Year 1994 Senate Labor, Health and Human
Services Appropriations bill and the Agriculture Appropriations bill to
establish and provide funding for Offices of Women's Health in the
Centers for the Disease Control and Prevention, CDC, the Food and Drug
Administration, FDA, the Health Resources and Services Administration,
HRSA, and the Agency for Health Care Policy and Research, AHCPR, now
the Agency for Healthcare Research and Quality, AHRQ. Today, there are
offices of women's health in HHS, FDA, CDC, and HRSA. AHRQ has a
women's health advisor. These offices and advisors are important
advocates within the agency for women's health research, programs, and
activities. A recent HHS report to Congress describes their roles,
responsibilities, and future plans. The degree of support for these
offices, in terms of staff and financial resources, varies widely
across HHS. This can mean inadequate and inconsistent attention to
women's health needs within an agency.
I believe we need a consistent and comprehensive approach to address
the
[[Page S5620]]
needs of women's health in the HHS. This bill would do just that. The
Women's Health Office Act of 2001 would authorize women's health
offices in HHS, CDC, FDA, AHRQ, and HRSA.
This legislation establishes an important framework and builds on
existing efforts. Under the bill, the HHS Office on Women's Health
would take over all functions which previously belonged to the current
Office of Women's Health of the Public Health Service. The HHS Office
would be headed by a Deputy Assistant Secretary for Women's Health who
would also chair an HHS Coordinating Committee on Women's Health. The
responsibilities of the HHS Office would include establishing short and
long-term goals, advising the Secretary of HHS on women's health
issues, monitoring and facilitating coordination and stimulating HHS
activities on women's health, establishing a National Women's Health
Information Center to facilitate exchange of and access to women's
health information, and coordinating private sector efforts to promote
women's health.
Under this legislation, the Offices of Women's Health in CDC, FDA,
HRSA, and AHRQ would be housed in the office of the head of each agency
and be headed by a Director appointed by the head of the respective
agency. Responsibilities of the offices include: an examination of
current women's health activities, the establishment of short-term and
long-term goals for women's health, the coordination of women's health
activities, and the establishment of a coordinating committee on
women's health within each agency to identify women's health needs and
make recommendations to the head of the agency. The FDA office would
also have specific duties regarding women and clinical trials. The
director of each office would serve on HHS's Coordinating Committee on
Women's Health. The bill authorizes appropriations for all the offices
through 2006.
I believe that this bill will establish a valuable and consistent
framework for addressing women's health in the Department of Health and
Human Services. It will help to ensure that women's health research
will continue to have the attention and resources it needs in the
coming years. This bill is a priority of the Women's Health Research
Coalition. The Coalition is comprised of academic medical, health and
scientific institutions, as well as other organizations interested in
and supportive of women's health research. The Women's Research and
Education Institute recently released a list of 15 high-impact actions
Congress could take to improve the health of midlife women, including
the establishment of permanent offices of women's health at HHS and
related federal agencies. This bill is supported by over 45 other
organizations including the YWCA, the Society for Women's Health
Research, the National Partnership for Women and Families, Hadassah,
and the American Physical Therapy Association. I encourage my
colleagues to cosponsor and support this important legislation, and I
ask unanimous consent that a letter of support for this bill be printed
in the Record.
There being no objection, the letter was ordered to be printed in the
Record, as follows:
Women's Health Research Coalition,
Washington, DC, May 14, 2001.
Hon. Barbara Mikulski,
Hart Senate Office Building, U.S. Senate, Washington, DC.
Dear Senator Mikulski: As organizations representing
millions of patients, health care professionals, advocates
and consumers, we thank you for your leadership in
introducing the ``Women's Health Office Act of 2001.'' We
enthusiastically support this legislation and look forward to
its passage.
Historically, women's health has not been a focus of study
nor has there been adequate recognition of the ways in which
medical conditions solely or differently affect women and
girls. In the decade since attention began to focus on
disparities between the genders, scientific knowledge has
accumulated alerting us to the importance of considering the
biological and psychosocial effects of sex and gender on
health and disease.
We support the work of the offices of women's health in
ensuring that women and girls benefit equitably in the
advances made in medical research and health care services.
The legislation will provide for the continued existence,
coordination and support of these offices so that they
analyze new areas of research, education, prevention,
treatment and service delivery.
We appreciate your firm commitment to improving the health
of women throughout the nation.
Sincerely,
Women's Health Research Coalition; Society for Women's
Health Research; American Association of University Women;
American Medical Women's Association; American Osteopathic
Association; American Physical Therapy Association; American
Psychological Association; American Urological Association;
Association for Women in Science; Association of Women
Psychiatrists; Association of Women's Health, Obstetric and
Neonatal Nurses; Center for Ethics in Action.
Center for Reproductive Law and Policy, Center for Women
Policy Studies, Church Women United, Coalition of Labor Union
Women, General Board of Church and Society, the United
Methodist Church; Girls Incorporated; Hadassah; Jewish
Women's Coalition, Inc.; McAuley Institute; National Abortion
Federation; National Association of Commissions for Women;
National Center on Women and Aging; National Coalition
Against Domestic Violence; National Council of Jewish Women;
National Organization for Women; National Partnership for
Women and Families; National Women's Health Network; National
Women's Health Resource Center; National Women's Law Center;
NOW Legal Defense and Education Fund.
Organization of Chinese American Women; OWL; Religious
Coalition for Reproductive Choice; Society for Gynecologic
Investigation; Soroptimist International of the Americas; The
General Federation of Women's Clubs, The Woman Activist Fund,
Inc.; Voters for Choice Action Fund; Women Employed; Women
Heart: The National Coalition for Women with Heart Disease;
Women Work!; Women's Business Development Center; Women's
Health Fund at University of Minnesota; Women's Institute for
Freedom of the Press; Women's Research and Education
Institute; YWCA of the U.S.A.
______