[Congressional Record Volume 146, Number 68 (Tuesday, June 6, 2000)]
[Senate]
[Pages S4570-S4572]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. SNOWE (for herself and Ms. Mikulski):
  S. 2675. 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.


                   women's health office act of 2000

 Ms. SNOWE. Mr. President, I rise today to introduce the 
Women's Health Office Act of 2000 and I am pleased to be joined on this 
legislation by my friend and colleague, Senator Barbara Mikulski. 
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 2000 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 the leading cause 
among women.
  Today, members of Congress and the American public understand the 
importance of ensuring that both genders benefit equally from medical 
research

[[Page S4571]]

and health care services. Unfortunately, equity does not yet exist in 
health care, and we have a long way to go. Knowledge about appropriate 
courses of treatment for women lags far behind that for men for many 
diseases. For years, research into diseases that predominantly affect 
women, such as breast cancer, went grossly underfunded. And many women 
do not have access to reproductive and other vital health 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. Ten years, ago, as co-
chairs of the Congressional Caucus for Women's Issues (CCWI), 
Representative Pat Schroeder and I, along with Representative Henry 
Waxman, called for a GAO investigation 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 
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 104th 
Congress.
  And yet, despite all the progress that we have made, there is still a 
long way to go on women's health care issues. Last month, the GAO 
released a report--a ten-year update--on the status of women's research 
at NIH (``NIH Has Increased Its Efforts to Include Women in Research,'' 
published on May 2, 2000). This report found that since the first GAO 
report and the 1993 legislation, NIH has made significant progress 
toward including women as subjects in both intramural and external 
clinical trials.
  However, the report notes that the Institutes have 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 will include women in their trials--but then 
they will either not do analysis on the basis of sex, or if no 
difference was found, they will not publish the sex-based results.
  NIH has done a good job of improving participation of women in 
clinical trials, but our commitment to women's health this 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 Congress's 
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 the 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 don't 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 Congress's 
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 enduring offices dedicated to addressing the 
ongoing needs and gaps in research policy, programs, and education and 
training in women's health.
  Improving the health of American women requires a far greater 
understanding of women's health needs and conditions, and ongoing 
evaluation in the areas of research, education, prevention, treatment 
and the delivery of services. I urge my colleagues to join Senator 
Mikulski 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 my good friend and 
colleague, Senator Snowe, to introduce the Women's Health Office Act of 
2000. I'm pleased to join Senator Snowe in introducing this bill 
because it establishes an important framework to address women's health 
within the Department of Health and Human Services (DHHS).
  Historically, women's health needs were ignored or inadequately 
addressed by the medical establishment and the government. It is really 
only in the last ten years that the health of women has begun to 
receive more attention. A 1990 General Accounting Office (GAO) report 
acknowledged the historical pattern of neglect of women in health 
research, and especially the exclusion of women as research subjects in 
many clinical trials. 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 National Institutes of Health (NIH) ten 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 had no way of knowing 
because women were not 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 
of ensuring that women were 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.
  Last year, Senator Harkin, Senator Snowe, and I requested that GAO 
examine how well the NIH and ORWH was 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 because analysis of how interventions affect men 
and women is not being done. While the NIH is taking steps to address 
this, we are missing information from research done over the last few 
years about how the outcomes of the research varied or not for men and 
women.
  NIH is but one agency in the DHHS. Other agencies in DHHS 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 statutory authorization for 
offices dedicated to women's health. Other

[[Page S4572]]

agencies in HHS have a hodgepodge of women's health offices or 
advisors/coordinators, some of whom have experienced cuts in their 
funding. For example, funding for the Food and Drug Administration's 
(FDA) Office of Women's Health has decreased from $2 million in Fiscal 
Year 1995 to $1.6 million in Fiscal Year 2000. In addition, funding for 
the Centers for Disease Control and Prevention's (CDC) Office of 
Women's Health was cut more than 10% between Fiscal Year 1999 and 
Fiscal Year 2000.
  I believe we need a consistent and comprehensive approach to address 
the needs of women's health in the DHHS. This bill that I join Senator 
Snowe in introducing today would do just that. The Women's Health 
Office Act of 2000 would provide authorization for women's health 
offices in DHHS, CDC, the FDA, the Agency for Healthcare Research and 
Quality (AHRQ), and the Health Resources and Serivces Administration 
(HRSA).
  This legislation establishes an important framework and build on 
existing efforts. 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 Heath. 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. The offices would assess the current level of activity on 
women's health in the agency; establish short-term and long-term goals 
for women's health and coordinate women's health activities in the 
agency; identify women's health projects to support or conduct; consult 
with appropriate outside groups on the agency's policy regarding women; 
serve on HHS' Coordinating Committee on Women's Health; and establish 
and head a coordinating committee on women's health within the agency 
to identify womens' health needs and make recommendations to the head 
of the agency. The FDA office would also have specific duties regarding 
women and clinical trials. All the offices, including the HHS Office 
beginning no later than Jan. 31. 2002, would submit a report every two 
years to the appropriate Congressional committees documenting 
activities accomplished. In addition, the bill authorizes 
appropriations for all the offices through 2005
  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 resources it needs in the coming years. This 
bill is a priority of the Women's Health Research Coalition. The 
Coalition is comprised of nearly three dozen academic centers, 
voluntary health associations and membership organizations with a 
strong focus on women's health research and gender-based biology. I 
encourage my colleagues to join Senator Snowe and myself in supporting 
and cosponsoring this important legislation for women.
                                 ______