WHO lauds US fast-track initiative on AIDS drugs
The United Nations public health organization today welcomed the recent announcement by the United States that it would speed up to as little as a few weeks its review of the fixed-dose and co-packaged therapies for HIV/AIDS that will be financed for developing countries by international donors.
The United Nations public health organization today welcomed the recent announcement by the United States that it would speed up to as little as a few weeks its review of the fixed-dose and co-packaged therapies for HIV/AIDS that will be financed for developing countries by international donors.
"With the help of our partners we have developed simplified treatment approaches and pre-qualified, fixed-dose combinations of antiretroviral drugs. Because of its importance to accelerating drug access, we will further develop and expand this initiative," World Health Organization (WHO) Director-General Lee Jong-wook said.
"I welcome the announcement made [Sunday] by the US Government for a proposed rapid process for review of fixed-dose combinations and co-packaged products. It is essential that medicines used in treatment programmes financed by international donors be affordable and meet international quality, safety and efficacy requirements."
US Secretary for Health and Human Services Tommy Thompson made the announcement of the fast-track review by the US Food and Drug Administration (FDA).
WHO's Prequalification System, established in 2001, has approved some fixed-dose combination anti-retroviral medicines, Dr. Lee said.
The System is operated in collaboration with the Joint UN Programme on HIV/AIDS (UNAIDS), the UN Children's Fund (UNICEF) and the UN Population Fund (UNFPA), with support from the World Bank and the Global Fund to Fight AIDS, Tuberculosis and Malaria, WHO said.