[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

[[Page S5619]]

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.
                                 ______