*EPF114 05/17/2004
U.S. Health Officials Discuss New Review Process for HIV/AIDS Drugs
(FDA will speed review of combination drug therapies, generics) (810)

By Wendy Lubetkin
Washington File Staff Correspondent

Geneva -- The United States has announced a new rapid-approval procedure for combination HIV/AIDS therapies that will allow the United States to provide life-saving drugs at lower prices to millions of people in the worst affected countries in the developing world.

The plan also opens the way for foreign drug manufacturers -- including the makers of generics -- to compete to provide HIV/AIDS combination therapies for use in U.S. government assistance programs.

"We are going to deliver on the President's promise," said Tommy G. Thompson, U.S. Secretary of Health and Human Services. "We are going to help turn the tide on this global epidemic."

"Today, I'm happy to announce that we have developed a faster, a new, expedited FDA [Food and Drug Administration] process to review new combination antiretroviral drugs," he said. "We will create a level playing field for all companies willing to submit products for FDA review." The FDA is part of the Department of Health and Human Services.

Thompson spoke at a May 16 press conference in Geneva one day before the opening of the World Health Assembly (WHA), the annual United Nations conference that brings together top health officials and leading experts from around the world.

Under the program -- which takes effect May 17 -- the FDA has established a rapid review procedure for "combination products" that either bring together different HIV/AIDS drugs in a single medication or provide combinations of drugs in a single package, thereby facilitating patients' compliance with often complicated drug regimens.

Acting FDA Commissioner Lester M. Crawford said he believes the expedited procedure will allow the FDA to review new products within four to eight weeks, and said his office is ready for various countries around the world to submit packages for approval. "We have the staff committed and the funds committed, thanks to Secretary Thompson, in order to make this real a few hours from now."

U.S. Global AIDS Coordinator Randall L. Tobias said his office has always been committed to using the best possible drugs at the lowest possible price, but the challenge has been that many copies of research-based HIV/AIDS drugs on the market in the developing world have never been reviewed by a stringent regulatory authority.

The new FDA procedures "will make it not only possible, but relatively fast and easy, for every manufacturer, every manufacturer to submit their AIDS drugs to that same scrutiny," Tobias explained. "And if they meet the appropriate standards -- as we hope many will do -- they can then be approved for potential funding by the President's Emergency Plan."

"Patients in Africa deserve the same assurances of safety and efficacy that we expect in the U.S. and the rest of the developed world," he said.

Tobias recalled that many experts over the years have argued that bringing antiretroviral therapies to Africa on a large scale could never happen because the problems were simply too complex.

"Well they were wrong; it is happening now, today," he said. "Thanks to the generosity of the American people as well as many other donor nations, the donors to the Global Fund, the World Bank, companies in the private sector, private foundations and others ... millions more patients will follow those who are already receiving this life extending treatment. And as that happens, drug availability will also need to be scaled up to an unprecedented level in order to fuel this newly expanded treatment capacity."

Tobias said the future need for antiretroviral drugs might well exceed existing drug companies' capacity to produce them. "For that reason, and for reasons of the local sustainability of this effort, I believe indigenous manufacturing of drugs in places like Africa has to be part of the long-term answer to HIV/AIDS, and I want to encourage that development."

"That's another reason why today's announcement is so ground-breaking. By creating a path for drugs produced in poor countries to serve people in poor countries, I hope that we in the United States are sending a strong signal to Africa that this is a development need and a business opportunity that should be strongly considered," he said.

Thompson and Tobias said they were encouraged by the "enormous momentum" in the international community to confront the HIV/AIDS pandemic. "There is a tremendous degree of optimism, great coordination, and more resources available to fight HIV/AIDS, tuberculosis and malaria than ever before," Thompson said.

"HIV/AIDS may be more prevalent in some countries than in others, but this is something we all have to see as a global problem," said Tobias. "It is something we all own, and everybody needs to do everything they can do address it."

(The Washington File is a product of the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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