One does wonder when the arrogance of FDA grew so enormous that they
became the FDA of the Planet Earth. Ugh. Well, that's what happens
when it is run by an industry slut like Tommy Thompson, who helped
push through the boondoggle Medicare drug prescription act that is
nothing but a great big slush fund for the rapists and genocidal sh.ts
of the pharmaceutical industry.

George M. Carter

****
MSF statement on US government announcement of new procedure for
reviewing the safety and efficacy of fixed-dose combinations and
co-blisters of antiretrovirals

May 18, 2004

On May 16, the United States announced that the US Food and Drug
Administration would set up a “rapid processâ€? for reviewing fixed
dose combinations (FDCs), co-packaged products, and single ingredient
antiretrovirals (ARVs) for the treatment of HIV/AIDS, particularly for
use in programmes financed by the US President’s Emergency Plan for
AIDS Relief (PEPFAR).

It is positive that the US has finally recognized the importance of
treatment simplification and the central role of FDCs in scaling up
ARV therapy and promoting adherence in developing countries. This
recognition is long overdue.

However, MSF believes that, rather than creating a unilateral system
which unnecessarily complicates and delays matters, the US should
support the existing WHO prequalification system, and lend the
technical expertise of FDA officials to the process. The US has
repeatedly been invited and encouraged to take part in the
prequalification project and has consistently refused to collaborate.

The WHO pre-qualification process is based on international standards,
guidelines and norms that allow quality and safety assessment of
medicines. These standards have been developed and approved by the WHO
Expert Committee system involving all WHO member states and WHO
governing bodies, and the prequalification project has ongoing
technical input from regulatory authorities in both developed and
developing countries.

It is the World Health Organization, and not the US Food and Drug
Administration, which has the mandate to set international standards
for quality, safety, and efficacy. There is no justification for
further delaying the availability of medicines that are already saving
lives and that are already certified by the WHO as meeting stringent
international standards for quality, safety, and efficacy.

Médecins Sans Frontières provides ARV therapy to more than 13,000
people with HIV/AIDS in over 20 countries in Africa, Asia, Latin
America, and Eastern Europe. More than half of our patients are on WHO
prequalified generic triple FDCs. We know from our direct field
experience that these generic FDCs are prolonging lives. Patients’
CD4 cell counts are rising, they are gaining weight, they are
experiencing fewer opportunistic infections, and they are adhering to
their two-pill-a-day regimens at unusually high rates ­ in short,
these ARVs are transforming HIV from a death sentence into a somewhat
manageable illness, even in some of the poorest and most remote
settings.
---
Rachel M. Cohen
U.S. Director, Campaign for Access to Essential Medicines
Doctors Without Borders/Médecins Sans Frontières (MSF)
333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA
Tel: +1-212-655-3762
Mobile: +1-917-331-9077
Fax: +1-212-679-7016
E-mail: rachel.cohen@newyork.msf.org

http://www.doctorswithoutborders.org/
http://www.accessmed-msf.org/