*EPF116 05/17/2004
Text: Global Fund Backs U.S. Move on AIDS Drugs
(Combination drugs will help global treatment expansion) (990)

The Global Fund to Fight AIDS, Tuberculosis and Malaria has hailed the May 16 U.S. announcement to speed review and approvals for fixed-dose combination AIDS drugs. The Geneva-based granting agency said the availability of these medications will help facilitate its efforts to scale up AIDS treatment in more than 100 developing nations.

The United States announced May 16 that the Food and Drug Administration (FDA) will establish an expedited process for evaluating the quality and safety of the combination drugs. If the medications pass those tests, then the United States will be in a position to buy them for distribution in 14 nations that are the focus of the President's Emergency Plan for AIDS Relief.

The combination drugs blend several antiretroviral medications into a single dosage, thus creating a drug regimen that is easier for patients to follow. In making the U.S. announcement, Health Secretary Tommy G. Thompson said, "Fixed dose combination products and co-packaged products are an important tool in improving the quality of health care in developing nations."

In a May 17 news release, Global Fund Executive Director Richard Feacham said, "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 chose them." The combination drugs are made by generic manufacturers, not by the pharmaceutical companies who developed the medications. International patent agreements allow them to be sold in nations that face a health crisis.

Three major pharmaceutical companies -- Bristol-Meyers Squibb, Gilead Sciences and Merck & Co. -- also announced May 16 that they plan to begin manufacture of a fixed dose combination drug. The Global Fund press release says that decision improves the prospects for a wider selection of the medications to become available.

The original U.S. announcement is available at http://usinfo.state.gov/gi/Archive/2004/May/16-52900.html

The Global Fund Web site is available at http://www.theglobalfund.org/en/

Following is the text of the Global Fund press release:

(begin text)

The Global Fund
To Fight AIDS, Tuberculosis and Malaria

Press Releases

Monday, 17 May 2004

The Global Fund Welcomes Moves to Facilitate Wider Use of Fixed-Dose Combination Drugs Against AIDS

Geneva, Switzerland - 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 is a unique global public-private partnership dedicated to attracting and disbursing additional resources to prevent and treat AIDS, tuberculosis and malaria. This partnership between governments, civil society, the private sector and affected communities represents a new approach to international health financing. The Fund works in close collaboration with other bilateral and multilateral organizations to supplement existing efforts dealing with the three diseases. The Global Fund has already committed $2.1 billion to programs in 122 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.

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(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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