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[e-drug] FDC ARV meeting Botswana 29-30 March

E-DRUG: FDC ARV meeting Botswana 29-30 March
[This might become an important meeting: SADC (the Southern African
Development Community, which has 14 member countries; see www.sadc.int),
WHO, UNAIDS and the US Department of Health and Human Services (HHS) are
organising a "technical" (?) meeting to discuss a draft guideline for FDCs.
Some have suggested that the US is trying to make FDC ARVs very difficult
(as big farma cannot make them, and does not want the generic companies to
get the market) but the meeting is becoming an open meeting (max 150 seats
however, please rush if you want to take part!) and the draft guideline
seems to be more or less OK.

There is a special website for the meeting with all papers:

E-drug would welcome a debate on the draft FDC guideline.

Conference and Report on Fixed-Dose Combination (FDC) Drug Products:
Scientific and Technical Issues related to Safety, Quality, and
March 29-30, 2004
Gaborone , Botswana

*  Joint United Nations Programme on HIV/AIDS (UNAIDS)
*  World Health Organization (WHO)
*  Southern African Development Community (SADC)
*  United States Department of Health and Human Services (HHS)


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 Draft Agenda at
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 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.

*For those who are unable to participate in the conference, please submit
technical comments to Ann Borlo (abarlo@s-3.org) by 5 p.m. EST on Thursday,
March 25. Comments will be made available to conference participants and the
expert planning group. Please specify which portion of the report your
comments pertain to, and please limit your comments to three pages or less,
if possible.

Who Should Attend? (Registration Form and Fact Sheet -
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.

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