Press release |

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

Geneva, May 18, 2004 — On May 16, the United States announced that the US Food and Drug Administration would set up a “rapid process” 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.