II 109th CONGRESS 1st Session S. 550 IN THE SENATE OF THE UNITED STATES March 8, 2005 Mr. Corzine (for himself, Mr. Obama, Ms. Snowe, Mr. Bingaman, Mrs. Boxer, Ms. Cantwell, Mrs. Clinton, Mr. Dodd, Mr. Durbin, Mrs. Feinstein, Mr. Kennedy, Mr. Lautenberg, Mr. Leahy, Ms. Mikulski, Mrs. Murray, Mr. Schumer, Mr. Smith, and Mr. Kerry) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act with respect to facilitating the development of microbicides for preventing transmission of HIV and other diseases, and for other purposes

1.

Short title

This Act may be cited as the Microbicide Development Act.

2.

Findings

Congress makes the following findings: (1) Women and girls are the new face of HIV/AIDS, and are increasingly affected by the disease in each region of the world. Women account for nearly 1/2 of the 37,000,000 adults living with HIV and AIDS worldwide as of 2005. Approximately 7,000 women are newly infected with HIV each day. (2) Because of their social and biological vulnerabilities, young women are particularly at risk. In Sub-Saharan Africa, 76 percent of the young people (between ages 15 and 24) with HIV are girls under 20. (3) When women become infected with HIV, they can pass along the infection to their children during pregnancy, labor and delivery, or breast-feeding. The most effective way to halt mother-to-child transmission is to ensure that mothers are not infected in the first place. (4) An increasing number of women who become infected with HIV have only 1 sexual partner, their husband. Unfortunately, marriage is not necessarily effective protection against HIV, because to protect themselves from HIV, women have to rely on their male partners to be faithful or to use condoms. Many women in the developing world are unable to insist on mutual monogamy or negotiate condom use, especially in long-term relationships. (5) Scientists are working on a promising new prevention tool that could slow down the spread of the HIV/AIDS epidemic, microbicides. Formulated as gels, creams, or rings, microbicides inactivate, block, or otherwise interfere with the transmission of the pathogens that cause AIDS and other sexually transmitted diseases (STDs). Microbicides could allow a woman to protect herself from disease. (6) Married couples need a method of HIV protection that will allow them to conceive a child and start a family. No existing HIV prevention method also allows conception. Microbicides are being developed to allow women to both conceive children and protect themselves from HIV. (7) Households in developing countries often dissolve when a mother dies. In the hardest hit countries, the number of children who are orphaned by AIDS is increasing dramatically. (8) Women in the United States also need HIV prevention tools like microbicides. AIDS is now the number 1 cause of death among African-American women between the ages of 25 and 34. (9) In addition to HIV, other STDs continue to be a major health threat in the United States. The United States has the highest rates of sexually transmitted diseases of any industrialized nation. Nineteen million STD infections occur every year. It is estimated that by age 25, 1/2 of all sexually active people in the United States can expect to be infected with an STD. (10) HIV and AIDS represent a threat to national security and economic well being, with direct medical costs of up to $15,500,000,000 per year. The pandemic undermines armies, foments unrest, and burdens the United States military. (11) As the Nation’s largest single provider of HIV/AIDS care, the Veterans Affairs health care system spent $359,000,000 to provided care to more than 20,000 American veterans with HIV/AIDS in fiscal year 2004. (12) The microbicide field has achieved an extraordinary amount of scientific momentum, with several first-generation candidates now in large scale human trials around the world. At same time, new products, based upon recent advances in HIV treatment, have advanced into early safety trials. (13) Microbicides are a classic public health good for which the social benefits are high but the economic incentive to private investment is low. Like other public health goods, such as vaccines, public funding must fill the gap. Microbicide research depends in large part on Government leadership and investment. (14) The Federal Government needs to make a strong commitment to microbicide research and development. Three agencies—the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the United States Agency of International Development (USAID)—have played important roles in the progress to date, but further strong, well-coordinated, and visible public sector leadership will be essential for the promise of microbicides to be realized. (15) As of 2005, microbicide research at NIH is conducted under several institutes with no single line of administrative accountability, no specific funding coordination, and highly variable levels of interest and commitment across institute leadership. Only a few NIH staff can claim microbicides as their sole focus. (16) The President's Emergency Plan for AIDS Relief (PEPFAR) recognizes the urgency of developing safe and effective microbicides to prevent HIV. In addition, NIH documents state that the US government is firmly committed to accelerating the development of safe and effective microbicides to prevent HIV, recognizing that microbicides may provide one of the most promising preventative interventions given that could be inexpensive, readily available, and widely acceptable. But as of 2005, NIH spends barely 2 percent of its HIV/AIDS research budget on microbicides. As more microbicide candidates are advanced into later-stage clinical trials and development costs rise correspondingly, 2005 funding levels are simply inadequate. (17) USAID and the CDC have expanded their microbicide portfolios, but without overall Federal coordination, costly inefficiencies and unproductive duplication of effort may result. USAID sustains strong partnerships with public and private organizations working on microbicide research, importantly including clinical trials in developing countries where its experience is extensive. USAID is well positioned to facilitate the introduction of microbicides once they are available. The CDC also engages in critical microbicide research and clinical testing, and has a long history of conducting field trials in developing countries. (18) HIV prevention options available as of 2005 are not enough. HIV prevention strategies must recognize women’s needs and vulnerabilities. If women are to have a genuine opportunity to protect themselves, their best option is the rapid development of new HIV-prevention technologies like microbicides, which women can initiate and control.