E-DRUG: Joint Statement on FDC Botswana meeting
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[this joint statement appreared 8 April; the promised next version is not
yet available on http://www.globalhealth.gov/fdc.shtml but was promised by
19 April. WB]
News Release
FOR IMMEDIATE RELEASE
Thursday, April 8, 2004
Contact: HHS Press Office (202) 690-6343
JOINT STATEMENT ISSUED REGARDING PRINCIPLES FOR FIXED-DOSE COMBINATION DRUG
PRODUCTS
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.