Support Microbicides in the FY19 Budget
Please use this form to sign your boss on to the FY 2020 appropriations letters supporting Microbicides. The text of both the LHHS and SFOPS letters are at the end of this form. DEADLINE IS TUESDAY, MARCH 26 at COB.
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Text of LHHS Letter
March XX, 2019
 
The Honorable Rosa D. DeLauro
Chairwoman
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Committee on Appropriations
U.S. House of Representatives
Washington, DC 20515

The Honorable Tom Cole
Ranking Member
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Committee on Appropriations
U.S. House of Representatives
Washington, DC 20515
 
Dear Chairwoman DeLauro and Ranking Member Cole:

As your Subcommittee prepares to consider its Fiscal Year (FY) 2020 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill, we request that you include language to encourage coordination amongst the National Institutes of Health (NIH), the Department of State (State), including the Office of U.S. Global AIDS Coordinator and U.S. Agency for International Development (USAID), and other partners in order to advance microbicide development and implementation efforts.  

The number of new HIV infections among young women is 44 percent higher worldwide than among young men. Given the fact that women, and especially young women, continue to be infected with HIV at alarming rates, new HIV prevention technologies such as microbicides for women are urgently needed. In 2016, a microbicide known as the dapivirine ring (a long-acting, monthly vaginal ring containing the antiretroviral drug dapivirine) was shown to safely reduce the risk of HIV infection for in women ages 18-45. Additional open label extension studies on the ring (which ended in 2018) have shown even further reduction of HIV risk among women. The dapivirine ring is currently under regulatory review to determine if the product will be licensed for use. If approved, the dapivirine ring would be the first biomedical HIV prevention method developed specifically for women and an important scientific breakthrough for women’s health.  There are also a number of promising microbicide products currently in earlier stages of the development pipeline to ensure next generation products with more advanced technology are available for improved protection against HIV.

Effective microbicides are needed to combat HIV because existing prevention methods (primarily condoms) are not always feasible for millions of women around the world. Power imbalances in many relationships do not allow women to make the decision to practice safe sex. In addition, gender inequities—including socioeconomic disparities, gender-based violence, and intimate partner violence—have been identified as key drivers of HIV transmission in Sub-Saharan Africa. Given this reality, women need a broader range of HIV prevention options so they can choose which HIV prevention product they like and can use consistently on their own terms. Microbicides are designed as discreet, female-initiated products that have the potential to empower women to protect their health. These products have the potential to significantly contribute to the achievement of the UN’s Sustainable Development Goals that seek to eliminate HIV/AIDS (Goal 3) and to achieve gender equality and women’s empowerment (Goal 5) by 2030.

Successfully confronting the AIDS pandemic requires a multi-faceted global HIV prevention strategy, and microbicides have the potential to be a new resource in the fight against HIV/AIDS. We ask that you support the Committee language below encouraging coordination between NIH and State, including USAID and OGAC, in the Committee Report accompanying the FY 2020 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill.  

Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Allergy and Infectious Disease (NIAID)
Microbicides. The Committee recognizes that with NIH and USAID leadership, research has shown the potential for antiretroviral (ARV) drugs to prevent HIV infection in women. The Committee encourages NIAID to continue coordination with USAID, the State Department, and others to advance ARV-based microbicide development efforts with the goal of enabling regulatory approval of the first safe and effective microbicide for women and supporting an active ARV-based microbicide pipeline to produce additional solutions to prevent HIV and to help end the epidemic.

Given the investments that have been made to date by the Federal government, including USAID and NIH, and the scientific progress made in developing the dapivirine ring as a new HIV prevention product; it is critical that Congress continues to support funding for microbicide research, development, and implementation.

Thank you for your attention to this request.

Sincerely,

JAN SCHAKOWSKY
Member of Congress

Text of SFOPS Letter
March XX, 2019

The Honorable Nita Lowey                                       The Honorable Hal Rogers
Chairman                                                                     Ranking Member
Subcommittee on State, Foreign Operations,       Subcommittee on State, Foreign Operations,
and Related Programs                                   and Related Programs
Appropriations Committee               Appropriations Committee
U.S. House of Representatives                                U.S. House of Representatives
Washington, DC 20515                                              Washington, DC 20515

Dear Chairwoman Lowey and Ranking Member Rogers:

As your Subcommittee prepares to consider its Fiscal Year 2020 State, Foreign Operations, and Related Programs Appropriations bill, we urge you to provide $45 million for microbicides research and development to prevent HIV.  We also request that you include language to encourage coordination amongst the Department of State, including the Office of the U.S. Global AIDS Coordinator and U.S. Agency for International Development (USAID), the National Institutes of Health (NIH), and other partners in order to advance microbicide development and implementation efforts.  

The number of new HIV infections among young women is 44 percent higher worldwide than among young men. Given the fact that women, and especially young women, continue to be infected with HIV at alarming rates, new HIV prevention technologies such as microbicides for women are urgently needed. In 2016, a microbicide known as the dapivirine ring (a long-acting, monthly vaginal ring containing the antiretroviral drug dapivirine) was shown to safely reduce the risk of HIV infection for in women ages 18-45. Additional open label extension studies on the ring (which ended in 2018) have shown even further reduction of HIV risk among women. The dapivirine ring is currently under regulatory review to determine if the product will be licensed for use. If approved, the dapivirine ring would be the first biomedical HIV prevention method developed specifically for women and an important scientific breakthrough for women’s health.  There are also a number of promising microbicide products currently in earlier stages of the development pipeline to ensure next generation products with more advanced technology are available for improved protection against HIV.

Effective microbicides are needed to combat HIV because existing prevention methods (primarily condoms) are not always feasible for millions of women around the world. Power imbalances in many relationships do not allow women to make the decision to practice safe sex. In addition, gender inequities—including socioeconomic disparities, gender-based violence, and intimate partner violence—have been identified as key drivers of HIV transmission in Sub-Saharan Africa. Given this reality, women need a broader range of HIV prevention options so they can choose which HIV prevention product they like and can use consistently on their own terms. Microbicides are designed as discreet, female-initiated products that have the potential to empower women to protect their health. These products have the potential to significantly contribute to the achievement of the UN’s Sustainable Development Goals that seek to eliminate HIV/AIDS (Goal 3) and to achieve gender equality and women’s empowerment (Goal 5) by 2030.

Successfully confronting the AIDS pandemic requires a multi-faceted global HIV prevention strategy, and microbicides have the potential to be a new resource in the fight against HIV/AIDS. We ask that you support a funding level of $45 million and the report language below to encourage the advancement of microbicides research and development in the Fiscal Year 2020 State, Foreign Operations, and Related Agencies Appropriations bill.  

U.S. Agency for International Development/State Foreign Operations
The Committee provides $45,000,000 for research on and development of microbicides to prevent HIV.
The Committee recommends continued support for antiretroviral (ARV) based microbicide development and introduction and directs the Office of the United States Global AIDS Coordinator (OGAC) to support microbicide development, implementation, and access strategies, especially given that research has shown that ARVs are highly effective in preventing HIV.  USAID should coordinate with OGAC, the National Institutes of Health, other Federal agencies, and donors to expedite microbicide development with the goal of enabling regulatory approval of the first safe and effective microbicide for women and supporting an active ARV-based microbicide pipeline to produce additional solutions to prevent HIV and to help end the epidemic. Within 45 days of enactment of this Act, the Committee directs USAID to provide a report on microbicide funding by recipient and activity and plans for Fiscal Year 2020 funds.

Office of the Global AIDS Coordinator
The Committee appreciates that OGAC’s “Blueprint for Creating an AIDS-Free Generation” recognizes the importance of supporting innovative research to develop new technologies for prevention, which includes microbicides. The Committee encourages OGAC to work with USAID in defining a pathway for product rollout and access.

Given the investments that have been made to date by the Federal government, including USAID and NIH, and the scientific progress made in developing the dapivirine ring as a new HIV prevention product; it is critical that Congress continues to support funding for microbicide research, development, and implementation.

Thank you for your attention to this request.

Sincerely,

JAN SCHAKOWSKY
Member of Congress

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