Microbicide Manufacturing Capacity Ramp-Up Urged In HIV Report
This article was originally published in The Tan Sheet
Executive Summary
Development of sufficient manufacturing capacities for microbicides will likely need to begin years in advance of regulatory approval in order to meet public health needs, an HIV prevention working group says
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Development of sufficient manufacturing capacities for microbicides will likely need to begin years in advance of regulatory approval in order to meet public health needs, an HIV prevention working group says. The Global HIV Prevention Working Group issued the report New Approaches to HIV Prevention: Accelerating Research and Ensuring Future Access during the 16th International AIDS Conference in Toronto, Canada Aug. 13-18. The report discusses microbicides, along with other HIV prevention methods such as cervical barriers, vaccines and pre-exposure prophylaxis with antiretroviral drugs, in a global health policy context. "To accelerate the implementation of new prevention methods...systems to purchase and deliver the intervention must be put in place, public health guidance must be developed and national regulatory expertise may need to be strengthened," the report says. For technologies such as microbicides, "several years can be required to build sufficient production capacity, and manufacturers may need to make decisions regarding initial manufacturing capacity in advance of initial regulatory licensure - that is, before large-scale efficacy trials have been completed," the group notes. In the development stage of new microbicides and other agents, manufacturers should undertake studies to "assess the acceptability of the method to consumers," the report advises. Acceptability studies "can inform efforts to ensure broad and correct adoption of new prevention methods," the authors say, citing developers of candidate microbicides for extensively researching acceptability of their products among sexually-active women and their male partners. The report urges governments to expedite the development of preventive measures. "National governments and donors should commit to providing the resources necessary for the rapid roll-out of new HIV prevention methods, as part of a comprehensive response to the global epidemic." "To be effective, guidance on emerging prevention methods must be timely so that donors, national policy-makers and program implementers can move swiftly to take advantage of new prevention approaches," the report says. "Unless national regulators are prepared for the potentially complex issues that some new HIV prevention technologies are likely to present, significant delays could result in the introduction of new prevention methods." The report sees a leadership role for regulatory agencies in developed countries, such as FDA and the EU's EMEA. At the request of developing countries, FDA and EMEA should review complete regulatory submissions "regarding new health interventions intended for primary use in developing countries, including new HIV prevention methods," the report recommends. Upon completion of the review, "the regulatory body would provide the requesting party with a summary of findings, with ultimate licensure decisions remaining the province of national regulatory authorities in countries where the new tool or strategy will be used," the report adds. The working group also recommends international agencies maintain a standing committee to "anticipate and assess the need for guidance on the introduction and proper use of new prevention approaches as they are shown to be effective in clinical trials." Currently, there are 28 microbicide candidate products internationally, according to the report. Five microbicide candidates are being tested in large-scale clinical trials for efficacy. The first results from C31G ( Savvy) , carbopol 974p (BufferGel ), cellulose sulfate, naphthalene sulfonate ( Pro 2000 ) and pc-515 ( Carraguard ) efficacy trials could potentially be available in 2008, according to the report. The UK's Microbicide Development Program announced its Phase III trial of Pro 2000 in October 2005 ("1 The Tan Sheet' Nov. 7, 2005, In Brief). Instead Sciences announced Aug. 1 its over-the-counter microbicide Amphora (acidform) could be on the market by 2010 2 ('The Tan Sheet' Aug. 7, 2006, In Brief). The firm is chaired by former HHS Secretary Tommy Thompson. - Rebekah Moan |