Joint Statement Issued Regarding Principles For Fixed-Dose Combination Drug ProductsDate: April 8, 2004
Source: Department of Health and Human Services (DHHS)
Joint statement of the Southern African Development Community (SADC), the United Nations Joint Programme on HIV/AIDS (UNAIDS), the U.S. Department of Health and Human Services (HHS) and the World Health Organization (WHO) on the Scientific and Technical Principles for Fixed-Dose Combination Drug Products:
In Gaborone, Botswana, government officials and representatives of drug regulatory agencies from 23 nations, the research-based and generic pharmaceutical industries, public health leaders, health care providers, advocacy groups (including persons living with HIV/AIDS), academia and members of non-governmental organizations held discussions from March 29-31 on the scientific and technical principles for fixed-dose combination drug products (FDCs) for use in the treatment of AIDS, tuberculosis and malaria, the most serious infectious disease threats facing the world today.
Combination therapies, either using single drugs administered together, or FDCs are considered by many to be essential to treating these diseases as well as to limiting the development of drug resistance. Among other advantages, FDCs simplify dosing which could result in better patient adherence to therapy.
Co-sponsors of the Botswana conference were SADC, UNAIDS, HHS and WHO. An expert panel consisting of regulators and other representatives of the co-sponsors had previously met in Cape Town, South Africa, in February 2004 to develop a working draft of shared scientific and technical principles for evaluating FDCs. This draft was then posted on the web for comment.
Before and during the conference, concerns were raised that this initiative was biased towards favoring innovators above generic manufacturers, in a way that might negatively affect access to badly needed medicines. However, the sponsors, representatives and experts who attended the Botswana Conference agreed that the principles, in whatever final form, are not intended to and would not impede access to safe, efficacious and quality FDCs by people living with HIV/AIDS.
The participants agreed to work towards a principles document, refining the previous working draft that incorporates the comments provided by Conference participants and those who submitted feedback electronically. In mid-April this revised draft document will be posted for two (2) weeks at: http://www.globalhealth.gov/fdc.shtml for further comment via e-mail.
The expert panel will consider additional comments and proceed to write the final document. The final principles document is expected to be made available in mid-May 2004.
It is anticipated that the principles document will be of use to regulatory agencies around the world, as well as to pharmaceutical companies and other organizations involved in developing and evaluating FDCs. It is not intended to be a therapeutic or regulatory guideline, nor address the procurement and distribution of specific products.
For more information go to: http://www.globalhealth.gov/fdc.shtml.