Washington Watch
Federal legislation coming on microbicides
By Cynthia Dailard
Senior Public Policy Associate
The Alan Guttmacher Institute
Washington, DC
Microbicides — gels, creams, or suppositories that kill or deactivate disease-causing microorganisms — have tremendous potential to prevent the transmission of sexually transmitted diseases (STDs), including HIV.
Despite the importance of new female-controlled technologies for the prevention of HIV and other STDs, particularly in developing countries, microbicide research and development has been underfinanced and extremely slow. Fearing that they will not recoup the large expense of bringing to market a new product designed, in part, to be sold at low cost worldwide, large pharmaceutical companies have shied away from the field. Instead, innovation in this area has depended almost exclusively on academics and small biotech companies that are short on capital and depend on federal support to bring products to market. (See information on microbicide research in two issues of Contracep-tive Technology Update : March 1999, p. 25, and April 1999, p. 40; the fight for research funding in the June 2000 issue, p. 69; and the latest research advances in the May 2001 issue of STD Quarterly, p. 1, inserted in CTU.)
Rep. Constance Morella (R-MD) is leading the charge on Capitol Hill to make vaginal microbicides a reality for women in this country and around the world. Yet Morella and other women’s health advocates fear that without enhanced government involvement in this area, the 60-some microbicidal products in development may never make it to market.
Focus on funds, efforts
At a time when microbicides hold enormous promise for improving the public health, federal investment in this area is insufficient to keep microbicides moving through the research and development pipeline and into the hands of women, says Morella. Less than 1% of the budget for AIDS-related research at the Bethesda, MD-based National Institutes of Health (NIH) is being spent on microbicide development, and less than half of that money supports product development.
Another problem is that microbicide research at the federal level is decentralized and lacks coordination, microbicide advocates charge.
Such research occurs within NIH, the Atlanta-based Centers for Disease Control and Preven-tion (CDC), and the Washington, DC-based U.S. Agency for International Development (USAID). To add another layer of complexity, microbicide research at NIH is housed within several institutes, with no single line of administrative accountability and no specific funding coordination. This lack of coordination and planning has lead to inefficiencies and duplication of effort in a field where resources are scarce, say advocates.
Seeking a solution
At the insistence of Morella and her House colleague, Rep. Nancy Pelosi (D-CA), NIH this year established a "microbicide program" and issued a five-year plan charting the future of microbicide research and development at NIH.
Sens. Patrick Leahy (D-VT), Arlen Specter (R-PA), and Tom Harkin (D-IA) secured $15 million in a foreign aid funding bill for microbicide research at USAID. That amount is nearly a $13 million increase over previous years.
Still more needs to be done, Morella says. This summer, she plans to introduce the Micro-bicide Development Act of 2001. Recognizing that $75 million is needed in fiscal year 2002 and $100 million is needed annually after that to capitalize on recent gains in this field, Morella’s legislation calls for a substantial increase in federal investment for microbicide research and development in order to significantly expand and intensify microbicide-focused activities at NIH and CDC.
The bill also would establish four Centers for Microbicide Research and Development across
the nation that would be devoted to research and development. The legislation also would require the secretary of health to coordinate federal microbicide activity and to collaborate with other federal agencies conducting work in this area.
The natural engines that drive new drug development have failed in the case of microbicides, so the government must take action, stated Morella at an April congressional meeting on the subject.
"With sufficient investment, a microbicide could be available within five years, to the very great benefit of the women of the world, their partners, and their children," she noted.
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