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View joint co-sponsors' post-conference statement

Background
HIV/AIDS, TB, and malaria are the foremost infectious disease threats to public health that the world faces today and are the focus of many global initiatives. Many consider combination therapy to be essential to the treatment of these diseases and to the prevention of drug resistance. An important approach to addressing the management of these diseases has included the development of fixed-dose combinations (FDCs) of individual components administered together to simplify treatment regimens, improve patient adherence, and facilitate the implementation of interventional programs and prevent the development of drug resistance. Notwithstanding the above, there will be cases where individual drugs must be utilized for certain patients because of the challenges of dose titration, allergies to one or more of the components, different pharmacokinetic and/or pharmacodynamic profiles, and pharmaceutical development. The development of FDCs may vary depending on their individual active components and on the indication(s) that they target. Currently, there are no uniform principles, guidelines, or international standards addressing the development of FDCs and their potential benefits or disadvantages in treating these diseases.  

Purpose of the Conference (View Agenda)
The conference will discuss the draft Scientific and Technical Principles for Fixed-Dose Combination Drug Products (Principles Document) developed by the Planning Group at its preparatory meeting in February 2004 in Cape Town, South Africa. During the opening session, presentations will place the draft Principles Document in a global context. Planning Group members will explain each of the various sections of the document and highlight areas on which comments would be especially helpful. The Conference participants will be asked by the Planning Group for feedback about specific sections of the document. The Planning Group will meet following the conference and make revisions to the draft document based on the conference deliberations. The conference co-sponsors plan to agree on the content of the final document within approximately two weeks after the conference.

Purpose of the Document    (View April 22 draft Principles Document)
The Principles Document focuses on aspects of the efficacy, safety, and quality of FDCs. The document provides points to consider when developing, evaluating, and/or considering combination products for use in programs that address optimum drug treatment combinations as fixed-dose drug combinations for the treatment of HIV/AIDS, tuberculosis, and malaria and their associated infectious diseases.

The document is not intended to be a therapeutic nor a regulatory guideline, and it will not address specific clinical or non-clinical quality issues or procurement and distribution of specific products. The document will not deal with procurement per se and treatment guidelines, patient adherence, or compliance with national regulatory requirements, or offer direct detailed regulatory guidance.

The co-sponsors and collaborators in this initiative expect that presenting a set of commonly agreed upon scientific and general principles, based on current knowledge, of quality, safety, and efficacy of FDCs for the treatment of HIV/AIDS, tuberculosis, and malaria, will contribute substantially to international and national efforts to fight these diseases.

*The comment period for the Principles Document on Fixed-Dose Combination
Drug Products is now closed. We thank those of you who commented on the document. All comments received by Tuesday, May 11 were forwarded to the Expert Panel. When the document is finalized it will be posted on this web site.

Who Should Attend?
In addition to the co-sponsoring organizations and the Planning Group members, we expect participation by government officials from drug regulatory authorities, public health leaders, health care providers, academia, procurement officials, the research-based and generic pharmaceutical industry, and non-governmental organizations—including patient groups, and international and regional organizations. The conference will be open to the public. Registration is limited to 150.

The conference will be held on Monday and Tuesday, 29–30 March 2004, 09:00–17:00 at the Gaborone Sun Hotel , Nyerere Drive North, Gaborone , Botswana. Phone: 267-395-1111; Fax: 267-390-2555.