17 May 2004
The Global Fund to Fight AIDS, Tuberculosis and Malaria welcomes U.S. Secretary for Health and Human Services, Tommy Thompson’s announcement Sunday of an expedited process for reviewing applications for new fixed-dose and co-packaged HIV/AIDS drugs.
The Global Fund is financing a major scaling up of AIDS treatment in over 100 developing countries, and simplified drug regimens play a crucial role in ensuring rapid scale-up and compliance in resource-poor settings. Fixed-dose combinations allow patients to reduce the number of pills they have to take to as few as one pill twice per day.
The Global Fund also welcomed the announcement by U.S. Global AIDS Coordinator Randall Tobias that drug patent issues should not impede purchase under the President’s Emergency Plan for AIDS Relief of fixed-dose combination drugs. Currently, only generic companies are producing the fixed-dose combinations.
The fast-track review by the U.S. Food and Drug Administration could reduce the time needed for approval of these combinations to as little as a few weeks.
“Recipients of Global Fund grants already have the opportunity to buy generic fixed-dose combinations, but clearly FDA approval of these drugs would lead many more countries to choose them,” says Richard Feachem, Executive Director of the Global Fund. “The fact that the President’s Emergency Plan also will allow the use of these drugs makes it much easier to harmonize drug protocols in countries where both the Global Fund and the President’s Emergency Plan finance drug purchases. It is important that patients can expect the same drugs no matter who they go to.”
The prospects of a wider selection of fixed-dose combination drugs were improved yesterday when three pharmaceutical companies, Bristol-Meyers Squibb, Gilead Sciences and Merck & Co, announced plans to develop a fixed-dose combination of three HIV medicines. The three companies also said they were looking into co-packaging separate HIV drugs to facilitate use.
“Fixed-dose combinations and co-packaging are the way of the future for AIDS drugs in developing countries,” says Professor Feachem. “We are very pleased that more companies are taking up the challenge by collaborating to create new solutions. Simpler drug regimens can save lives and prevent spread of resistance to HIV drugs. I am delighted that the research muscle of big pharma is now being applied to expand the number of fixed dose combinations and securing their effectiveness. This is reassuring and will bring benefits to people in all countries.”
The Global Fund has been established as an independent private foundation under Swiss law and is governed by an international Board. Apart from a high standard of technical quality, the Global Fund attaches no conditions to any of its grants. It is not an implementing agency. It relies on local ownership and planning to ensure that new resources are directed to programs on the frontline of this global effort, reaching those most in need. Its performance-based approach to grant-making - where grants are only disbursed if progress has been measured and verified - is designed to ensure that funds are used efficiently and create real change for people and communities.