109th Congress

Women's Health

S. 756/H.R. 3307, H.R. 987, S. 757/H.R. 2231, S. 37/H.R. 312, H.R. 3313/S. 1500, H.R. 3411, H.R. 1245, S. 550/H.R. 3854, H. Res. 833/S. Res. 487, H.R. 949/S. 569, H.R. 1940, S. 3529, H.R. 3034/S. 1289, S. 1580

Background

During the 109th Congress, more than 30 bills were introduced that addressed women’s health research issues. Women’s health legislation affecting the National Institutes of Health (NIH) addressed the issues of autoimmune disease research, breast cancer research, environmental factors affecting women’s health, feminine hygiene product research, gynecological and ovarian cancer, microbicides, National Women’s Health Week, the Office of Women’s Health, postpartum depression (PPD), and uterine fibroids. Most of this legislation had been introduced in the 107th and 108th Congresses but was not passed by either the House or Senate.

Provisions of the Legislation/Impact on NIH

Autoimmune Disease Research

• S. 756/H.R. 3307—Lupus Research, Education, Awareness, Communication, and Healthcare Amendments of 2005
  S. 756, introduced by Senator Robert Bennett (R-UT) on April 11, 2005, and H.R. 3307, introduced by Representative Ilena Ros-Lehtinen (R-FL) on July 29, would have required the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to expand, intensify, and coordinate activities with respect to research on lupus. This legislation also included a provision which would have required the National Center on Minority Health and Health Disparities (NCMHD) to conduct and support a sustained national lupus public awareness and health professional education campaign.
  
  In the 106th Congress, Senator Bennett and former Representative Carrie Meek (D-FL) sponsored the Lupus Research and Care Amendments, which were incorporated into the Public Health Service Amendments of 2000 (P.L. 106-505, enacted on November 13, 2000). P.L. 106-505 added a new section to the Public Health Service Act to require the Director of NIAMS to expand research related to lupus, coordinate with other NIH Institutes and Centers involved in lupus research, develop improved screening techniques, increase basic and clinical research, and create information and education programs for health care professionals. This legislation authorized such sums as may have been necessary for fiscal years (FYs) 2001 through 2003. S. 756 and H.R. 3307 would have amended this new section of the Act to require NIAMS to increase its lupus research efforts. The bills would have prescribed the types of basic research intended by the legislation, expanded the number of racial categories that NIAMS would have needed to study to determine the reasons for higher prevalence of lupus in these populations, added a requirement that NIAMS conduct and support research to validate lupus biomarkers and develop improved diagnostic tests, and deleted the original authorization of appropriations section.
  
  The legislation would have also required the Centers for Disease Control and Prevention (CDC) to expand epidemiological research and would have directed the Secretary of Health and Human Services (HHS) to enter into a contract with the Institute of Medicine to conduct a study to evaluate Federal and State activities related to lupus research, education, and awareness programs and make recommendations for ways in which these initiatives could be expanded. In addition, the bill would have directed the Secretary, acting through the Office on Women’s Health and in collaboration with the Lupus Foundation of America, Inc., and NCMHD, to conduct and support a sustained national lupus public awareness and health professional education campaign, with an emphasis on reaching the populations at highest risk for the disease. S. 756 was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP). H.R. 3307 was referred to the House Energy and Commerce Subcommittee on Health.

Breast Cancer Research

• H.R. 987—Annie Fox Act
  H.R. 987, introduced by Representative Lynn Woolsey (D-CA) on February 17, 2005, would have amended the Public Health Service Act language for the National Institute of Environmental Health Sciences (NIEHS) to add a new section on programs regarding breast cancer in younger women. The bill would have required NIEHS to expand and intensify basic and clinical research and education on the causes, prevention, detection, treatment, and long-term effects of breast cancer in younger women, including the long-term effects of treatment. The bill would have authorized $9 million annually for FYs 2006 through 2011 for research to determine the causes of breast cancer in younger women, investigate the long-term effects of cancer therapies on younger women, improve diagnostic tools and techniques, and increase educational outreach within the medical community and to the general public. The bill is named for Annie Fox, a breast cancer activist from Marin County, CA, who was diagnosed with breast cancer when she was 29 and died of the disease at age 35. H.R. 987 was referred to the House Energy and Commerce Subcommittee on Health.
• S. 757/H.R. 2231—Breast Cancer and Environment Research Act of 2005
  S. 757, introduced by Senator Lincoln D. Chafee (R-RI) on April 11, 2005, and H.R. 2231, introduced by Representative Nita M. Lowey (D-NY) on May 10, would have amended the Public Health Service Act to expand research on the relationship between environmental factors and the development of breast cancer through the creation of centers of excellence designed to study the issue. The legislation would have required the Director of NIEHS to make grants for the development and operation of not more than eight Breast Cancer and Environmental Research Centers of Excellence to study environmental factors related to the etiology of breast cancer. S. 757 also contained provisions that would have required the Secretary of HHS to establish a Breast Cancer and Environmental Research Panel to oversee the peer-review process and provide funding and programmatic recommendations about the centers to the Director of NIEHS. The nine-member panel would have comprised six physicians or health care professionals and three members of the general public who either have suffered from breast cancer or represent an affected constituency. This panel would have been in addition to the standard NIH peer-review panels. (Standard NIH peer-review panels include the initial review groups or study sections and NIH Institute and Center councils. Both legislatively mandated bodies were created to provide peer review.) This legislation would have authorized the centers for up to 5 years (FYs 2006 through 2011) at $30 million for each fiscal year and would have required the Director of NIEHS to ensure an equitable geographic distribution of centers, to the extent possible. S. 757 was referred to the Senate Committee on Health, Education, Labor and Pensions. H.R. 2231 was referred to the House Committee on Energy and Commerce.
• S. 37/H.R. 312—Breast Cancer Research Stamp Reauthorization Act
  S. 37, introduced by Senator Dianne Feinstein (D-CA) on January 24, 2005, and H.R. 312, introduced by Representative Joe Baca (D-CA) on January 25, extend the breast cancer stamp program for 2 years, through December 31, 2007. S. 37 was referred to the Senate Committee on Homeland Security and Governmental Affairs. H.R. 312 was referred to the House Committees on Energy and Commerce and on Armed Services. On September 27, the bill was passed by the Senate by unanimous consent, and on October 27, the bill was passed by the House. On November 11, the President signed S. 37/H.R. 312 into law as P.L. 109-100, which authorizes the extension of the special postage stamp for first-class mail.
  
  The Breast Cancer Research Stamp is the first stamp of its kind dedicated to raising funds for a special cause and was the result of P.L. 105-41, the Stamp Out Breast Cancer Act, enacted in August 1997. So far the U.S. Postal Service has sold 588.3 million of these stamps, raising $42.66 million for breast cancer research. The stamp costs 45 cents and is deemed valid as a 37-cent stamp. The additional 8 cents charged for each stamp is directed to research programs at NIH, which receives 70 percent of the proceeds, and the U.S. Department of Defense Breast Cancer Research Program, which receives the remaining 30 percent. Originally created in 1997, Congress has reauthorized the stamp four times. The original cosponsors for the bill were Senator Feinstein, former Senators Alfonse D’Amato (R-NY) and Lauch Faircloth (R-NC), and former Representatives Vic Fazio (D-CA) and Susan Molinari (R-NY)

Environmental Factors Affecting Women’s Health

Representative Louise McIntosh Slaughter (D-NY) and Senator Mary Landrieu (D-LA) introduced the Women’s Health Environmental Research Centers Act of 2000 in the 107th Congress. In the 108th Congress, Representative Slaughter and Senator Landrieu introduced similar legislation.

• H.R. 3313/S. 1500—Environmental Health Research Act of 2005
  H.R. 3313, introduced by Representative Slaughter on March 14, 2005, and S. 1500, introduced by Senator Landrieu on July 26, would have authorized NIEHS to develop multidisciplinary research centers regarding women’s health and disease prevention and to conduct and coordinate a research program on hormone disruption. The bills would have required NIEHS, in consultation with the Office of Research on Women’s Health (ORWH), to make grants for the development and operation of not more than six centers to conduct multidisciplinary research on environmental factors that may be related to the development of women’s health conditions. Each center would have been required to conduct basic and clinical research, develop training protocols, conduct training, develop model continuing education programs, and disseminate information to professionals and the public, with priority given to prevention activities. The bills would have required each center to 1) collaborate with community organizations and 2) use the facilities of a single institution or be formed from a consortium of institutions. The bills, which would have authorized appropriations, would have limited support to 5 years but allowed extensions under specified circumstances.
  
  This legislation would have also required NIEHS to establish a national program of research on hormone disruption within the Institute and, in doing so, to conduct research on the occurrence of hormone-disrupting chemicals in the environment and their effects on ecological and wildlife health, in cooperation with the U.S. Geological Survey (USGS). Furthermore, NIEHS would have been authorized to transfer funds to other Federal agencies to carry out these responsibilities. The Secretary of HHS would have been required to establish a commission to be known as the Hormone Disruption Research Interagency Commission to advise the Directors of NIEHS and USGS on the development of a comprehensive agenda for conducting research on hormone disruption and to recommend to the Directors a research program, including levels of funding for intramural and extramural research. It would have included a number of agencies, such as the National Institute of Child Health and Human Development (NICHD) and National Institute of Neurological Disorders and Stroke, in addition to NIEHS, which would have served as chair. NIEHS would have also been required to establish a Hormone Disruption Research Panel within the Institute. H.R. 3313 was referred to the House Energy and Commerce Subcommittee on Health. S. 1500 was referred to the Senate HELP Committee.

Feminine Hygiene Product Research

Dioxin is a toxic byproduct of a chlorine-bleaching process used in the manufacture of paper products, including the raw materials that are used in tampons. The Environmental Protection Agency has released reports identifying dioxin as a “probable cancer-causing agent” and linking dioxin exposure with increased risks for endometriosis. Other potential health risks from dioxin include immune system suppression, pelvic inflammatory disease, and infertility. Toxic shock syndrome (TSS) is a rare, potentially life-threatening bacterial illness associated with kidney and liver failure. Research has shown that TSS in menstruating women is related to the use of tampons that are too absorbent. While awareness of TSS was very high in the 1980s, many women now assume that the risk has been eliminated.

• H.R. 3411—Robin Danielson Act
  H.R. 3411, reintroduced by Representative Carolyn Maloney (D-NY) on July 22, 2005, would have amended the Public Health Service Act to add a new section entitled Dioxin in Feminine Hygiene Products. NIH, through ORWH, would have been required to support research to determine the extent to which the presence of dioxin, synthetic fibers, and other additives in tampons and other feminine hygiene products pose any risks to the health of women who use the products (including risks relating to cervical cancer, endometriosis, infertility, ovarian cancer, breast cancer, immune system deficiencies, pelvic inflammatory disease, and toxic shock syndrome) and pose any risks to the health of children of women who used such products before or during the pregnancies involved, including risks relating to fetal and childhood development. The bill would have also required the establishment of a research program on the risks posed by the presence of dioxin, synthetic fibers, and other additives in feminine hygiene products and the establishment of a program for the collection and analysis of data on TSS. CDC would have been required to carry out a program to collect, analyze, and disseminate data on TSS, including data on its causes. H.R. 3411 was referred to the House Energy and Commerce Subcommittee on Health.

Gynecological and Ovarian Cancer

The gynecological cancers comprise cervical, endometrial, ovarian, vulvar, and vaginal cancer. In 2005, it was estimated that there would be 10,370 new cases of cervical cancer with 3,710 deaths. For cancers of the endometrium, the estimate was 40,880 new cases with 7,310 deaths; for vulvar cancer, 3,870 new cases with 870 deaths; and for vaginal and other genital organs, 2,140 new cases with 810 deaths. The American Cancer Society predicted that 16,210 women would die of ovarian cancer in 2005 and that 22,220 new cases of the disease would be diagnosed.

In the United States, ovarian cancer is the seventh most common cancer among women and the fifth most common fatal cancer. Ovarian cancer kills 5 percent of all women who die from cancer, a death toll greater than any other gynecological cancer. It occurs in the United States with the same frequency as it did in 1973, but the mortality rate for women diagnosed with ovarian cancer has decreased by about 12 percent, due to increased awareness and medical research. Most cases of ovarian cancer occur in women over the age of 50. In the majority of women diagnosed with ovarian cancer, the cancer is detected only after it has spread, which significantly reduces survival rates. The Federal Government devotes millions of dollars annually to research increasingly successful treatment regimens and diagnostic tools to detect ovarian cancer in its early stages.

On May 11, 2005, Senator Arlen Specter (R-PA) held a hearing on gynecological cancers; witnesses included Dr. Andrew von Eschenbach, former Director of the National Cancer Institute; Fran Drescher, actress and gynecological cancer survivor; and Sheryl Silver, sister of Johanna, for whom the Gynecologic Cancer Education and Awareness Act of 2005 or “Johanna’s Law” is named.

• H.R. 1245—Gynecological Cancer Education and Awareness Act of 2005 (“Johanna’s Law”)
  H.R. 1245, introduced by Representative Darrell Issa (R-CA) on March 10, 2005, will 1) direct the Secretary of HHS to initiate a national campaign to increase women’s awareness and knowledge of gynecologic cancers and 2) require the Secretary to award grants for demonstration projects to test different outreach and education strategies to increase the awareness and knowledge of women and health care providers with respect to gynecologic cancers. Authorizations of appropriations are provided for both initiatives; however, no agency is mentioned as the entity responsible for addressing this. H.R. 1245 was referred to the House Committee on Energy and Commerce, and on November 14, 2006, the bill was considered in the House under suspension of the rules and was passed with an amendment agreed to by a voice vote. The measure was received by the Senate and on the last day of the 109th Congress, December 8, was passed with an amendment to Section 317P of the Public Health Service Act (42 U.S.C. 247b-17) by adding “Johanna’s Law” at the end of the section heading, as proposed by Senator Michael B. Enzi (R-WY), by unanimous consent. In the early morning hours of the following day, Representative Joe Barton (R-TX), former chair of the House Committee on Energy and Commerce, asked the House to agree to the Senate amendment, which it did without objections. The bill was cleared for the White House and presented to the President on January 3, 2007. On January 12, the President signed H.R. 1245 into law as P.L. 109-475.

Microbicides

The role of and need for microbicides to prevent the spread of sexually transmitted diseases, in particular HIV/AIDS, have long been recognized by Members of Congress. For several Congresses, former Representative Connie A. Morella (R-MD) introduced legislation on this topic, and in the 107th Congress, she was joined in her pursuit of such legislation by former Senator Jon S. Corzine (D-NJ), who introduced his own microbicide bill. Neither bill received final action in the 107th Congress. In the first session of the 108th Congress, Senator Corzine introduced a revised version of his earlier legislation. Although no other bills specifically targeting microbicide development were introduced in the 108th Congress, a number of global HIV/AIDS and foreign assistance bills contained provisions supporting the need for microbicides.

• S. 550/H.R. 3854—Microbicide Development Act
  S. 550 was introduced by Senator Corzine on March 8, 2005, and H.R. 3854 was introduced by Representative Christopher Shays (R-CT) on September 21, to encourage new investments in microbicide research at NIH. In his introductory remarks, Senator Corzine stated that such research is currently conducted with no single line of administrative accountability or specific funding coordination. In actuality, NIH devotes considerable resources to microbicide research, which is coordinated by the NIH Office of AIDS Research (OAR).
  
  S. 550, a slightly modified version of Senator Corzine’s earlier legislation, would have required the Director of OAR to expedite the development and implementation of a Federal microbicide research and development strategic plan and coordinate the plan with other Federal agencies, the microbicide research community, and health advocates and to expand, intensify, and coordinate the activities of all appropriate NIH research components with respect to research on the development of microbicides to prevent the transmission of HIV and other sexually transmitted diseases. A report to Congress on Federal microbicide research and development implementation strategies would have also been required. In addition, the National Institute of Allergy and Infectious Diseases would have been required to establish, fully staff, and fund a clearly defined microbicide research unit within the Institute’s Division of AIDS in order to conduct microbicide research to integrate basic science and clinical research, with particular emphasis on implementation of clinical trials leading to product licensure. S. 550 was referred to the Senate HELP Committee. H.R. 3854 was referred to the House Committee on Energy and Commerce Subcommittee on Health.

National Women’s Health Week

• H. Res. 833/S. Res. 487
  H. Res. 833, introduced by Representative Maurice Hinchey (D-NY), and S. Res. 487, introduced by Senator Russ Feingold (D-WI), express the sense of the House and Senate, respectively, with regard to the importance of National Women’s Health Week, which promotes awareness of diseases that affect women and encourages women to take preventive measures to ensure good health. The resolution was passed by the House by a two-thirds majority vote and by the Senate by unanimous consent as amended by a voice vote. This measure recognizes the importance of preventing diseases that commonly affect women, calls on the people of the United States to use the week of May 14–20 as an opportunity to learn about women’s health issues, calls on women to observe National Women’s Check-Up Day by receiving preventive screenings from their health care providers, and recognizes the importance of programs that provide research and collect data on common diseases in women.

Office of Women’s Health

• H.R. 949/S. 569—Women’s Health Office Act of 2005
  H.R. 949 was introduced by Representative Maloney on February 17, 2005, and S. 569 was introduced by Senator Olympia J. Snowe (R-ME) on March 8, to establish in statute an Office of Women’s Health within the Office of the Secretary of HHS, headed by a Deputy Assistant Secretary for Women’s Health. This legislation was first introduced in 2001 by Senator Snowe and former Representative Morella. The bill would have established women’s health offices in CDC, the Health Resources and Services Administration (HRSA), and the Food and Drug Administration and would have required the Agency for Healthcare Research and Quality to designate an official of the Office of Priority Populations to carry out similar responsibilities relating to women's health. Under current law, only NIH and the Substance Abuse and Mental Health Services Administration have permanent authorizations for their offices on women’s health. The bill would have required the Secretary, acting through the Office of Women’s Health, to establish a National Women’s Health Information Center to facilitate the exchange of information, access to such information, and the analysis of issues and problems relating to women's health and would have transferred the functions of the Office on Women’s Health of the Public Health Service to the Office on Women’s Health within the U.S. Department of Health and Human Services (DHHS). The establishment of a DHHS Coordinating Committee on Women’s Health, chaired by the Deputy Assistant Secretary for Women’s Health and comprising senior-level representatives from each of the agencies and offices of DHHS, would have also been required.
  
  The Office of Women’s Health would have been responsible for 1) establishing goals and objectives and coordinating all activities within DHHS related to disease prevention, health promotion, service delivery, research, and public and health care professional education, 2) providing advice to the Secretary of HHS concerning scientific, legal, ethical, and policy issues, and 3) facilitating the coordination of departmental and agency offices on women’s health. H.R. 949 was referred to the House Energy and Commerce Subcommittee on Health. S. 569 was referred to the Senate HELP Committee.

Postpartum Depression

PPD is the most common medical complication related to childbearing. It is estimated that 10 to 15 percent of new mothers annually (400,000 to 800,000 women) will experience PPD. Symptoms include frequent crying, sleep disturbances, appetite disturbances, anxiety and panic attacks, obsessive-compulsive thoughts or behavior, and suicidal thoughts that often develop a few weeks after delivery but can occur at any time during the first year after childbirth.

• H.R. 1940—Melanie Blocker-Stokes Postpartum Depression Research and Care Act
  H.R. 1940, introduced by Representative Bobby L. Rush (D-IL) on April 27, 2005, would have required the Director of NIH and the Director of the National Institute of Mental Health to expand and intensify basic research concerning the etiology and causes of PPD and postpartum psychosis; conduct epidemiological studies to address the frequency and natural history of these conditions and the differences among racial and ethnic groups with respect to them; provide for the development of improved diagnostic techniques; conduct clinical research for the development and evaluation of new treatments, including new biological agents; and disseminate information to and conduct education programs for health care professionals and the public. The bill would have authorized such sums as may have been necessary for each of the FYs 2006 through 2008. The bill is named for Melanie Blocker-Stokes, who jumped to her death on June 13, 2001, after developing postpartum psychosis. H.R. 1940 was referred to the House Committee on Energy and Commerce Subcommittee on Health.
• S. 3529—Mom’s Opportunity to Access Help, Education, Research, and Support for Postpartum Depression or MOTHERS Act
  S. 3529 was introduced by Senator Robert Menendez (D-NJ) for himself and Senator Richard J. Durbin (D-IL) on June 15, 2006, to ensure that new mothers and their families are educated about PPD and screening for its symptoms and provided with essential services and to increase research at NIH on PPD. This measure would have required doctors and nurses to educate every new mother and her family about PPD before they leave the hospital so that they can understand what might occur and where to get help. It would have also offered screening for PPD during the first year of postnatal checkup visits and provided social services for new mothers struggling with the condition. The bill proposed increasing funding for PPD at NIH to support the development of tools for treating and preventing this devastating condition. S. 3529 was referred to the Senate HELP Committee.

Uterine Fibroids

Uterine fibroids (leiomyomata uteri) are the most common benign (noncancerous) tumors present in the muscular wall of the uterus of women over age 30 and are more common in African American women. According to the most current textbooks of medicine, it is estimated that leiomyomas are present in 20–25 percent of reproductive-age women but are 3 to 9 times more frequent in African American women than in White women. However, a recently completed epidemiological study of uterine fibroids by NIEHS found that by age 50, the cumulative incidence of uterine fibroids was more than 80 percent for African American women and about 70 percent for White women. These numbers are much higher than reported from medical records. The differences suggest that while many women have fibroids, not all have clinically symptomatic fibroids and seek medical care. Data suggest that large fibroids cause more symptoms than small fibroids, leading scientists to question what causes fibroids to grow and become clinically symptomatic. Representative Stephanie Tubbs Jones (D-OH) and Senator Barbara A. Mikulski (D-MD) were joint sponsors of uterine fibroid legislation in the 108th Congress. The NIH portion included authorization levels of $10 million annually for uterine fibroid research for 5 years in that measure.

• H.R. 3034/S. 1289—Uterine Fibroid Research and Education Act of 2005
  H.R. 3034 and S. 1289, introduced by Representative Tubbs Jones and Senator Mikulski, respectively, on June 22, 2005, would have directed NIH to expand and intensify research efforts on uterine fibroids and authorize $30 million for FYs 2006 through 2010 for research on this condition through NICHD, NIEHS, ORWH, and NCMHD. ORWH would have been required to coordinate activities among the Institutes, Offices, and Centers of NIH. CDC would have been responsible for the development of a Uterine Fibroids Public Education Program. Both CDC and HRSA would have been required to develop information on uterine fibroids and disseminate it to health care providers and other relevant groups. H.R. 3034, which is identical to S. 1289, was referred to the House Energy and Commerce Subcommittee on Health. S. 1289 was referred to the Senate HELP Committee.
• S. 1580—Healthcare Equality and Accountability Act
  S. 1580 was introduced by Senator Daniel K. Akaka (D-HI) on July 29, 2005, to address various efforts to improve the health of minority individuals. This measure was introduced in the 108th Congress by Representative Elijah Cummings (D-MD) and former Senator Thomas A. Daschle (D-SD). Among the many provisions included in S. 1580 is one that would have required the Director of NIH to expand, intensify, and coordinate programs for the conduct and support of research with respect to uterine fibroids, to be carried out through the appropriate Institutes, Offices, and Centers, including NICHD, NIEHS, ORWH, NCMHD, and any other agencies that the Director of NIH deemed appropriate. ORWH would have been responsible for coordinating activities within NIH. The bill would have authorized such sums as may have been necessary for each of the FYs 2007 through 2012. S. 1580 was referred to the Senate Committee on Finance. For more information on this legislation, see the article entitled “Healthcare Equality and Accountability Act.”

Status and Outlook

No further action occurred on any of this legislation during the 109th Congress, except for the breast cancer stamp reauthorization legislation enacted in the first session of the 109th Congress, which extends the authority for the stamp until December 31, 2007, and H.R. 1245, the Gynecological Cancer Education and Awareness Act of 2005, which was passed by the House and Senate with an amendment and signed into law by the President as P.L. 109-475.