White House shifts policy on AIDS drugs

Quicker approval a help to developing nations


WASHINGTON -- The Bush administration announced a significant shift in its AIDS policy yesterday, expediting the approval process for generic and combination anti-retroviral drugs so they can be bought at lower prices and provided more efficiently and safely to millions of infected people in Africa and the Caribbean.

The expedited process is also designed to encourage manufacturers to create a single pill, consisting of two or three licensed anti-retroviral drugs that are more potent when taken together. Further, the speedier process will allow manufacturers to put combinations of these anti-retroviral drugs into single, easy-to-dispense packages, eliminating the confusing jumble of dosages that can hamper compliance with AIDS treatment, especially among the poor and illiterate.

The quicker action aims at encouraging manufacturers to produce the fixed-dose combinations to ease delivery of drugs in remote areas in severely affected countries and make their use safer.

At the same time, the Food and Drug Administration will provide speedy review of applications from foreign manufacturers to sell as generics in developing countries anti-retroviral drugs patented in the United States. Such approved generic drugs will be eligible for purchase under the Bush administration's $15 billion AIDS relief program, largely for countries in Africa and the Caribbean.

Approval for some combinations and generics could come as soon as two to six weeks after application, said Tommy G. Thompson, secretary of health and human services. Such approvals usually take six months, he said.

Thompson announced the policy change at a news conference in Geneva, where delegates from the World Health Organization were gathering for its annual meeting that begins today.

The Bush administration had been expected to be the target of heavy criticism at the weeklong meeting for its previous reluctance to approve inexpensive combinations of patented anti-retroviral AIDS drugs. In the past, the United States had insisted on more stringent criteria for inexpensive generic copies of these drugs and for approving fixed-dose combinations of them.

Advocacy groups had accused the Bush administration of bowing to pressure from the U.S. pharmaceutical industry by delaying approval of less costly generic copies to promote the sale of the more expensive, patented originals. The policy change announced yesterday could blunt much of that criticism.

Thompson declined to estimate how long it would take for anti-retroviral drugs to reach the people who need them, once the drugs have been approved.

It was unclear what specifically had contributed to the administration's change of policy, although the U.S. pharmaceutical industry had clearly been briefed about it in advance. Some big drug companies quickly issued favorable responses.

International health officials also welcomed the announcement.

"It's a pretty radical change in U.S. policy, if applied," Dr. Peter Piot, the director of the United Nations AIDS program, said yesterday in a telephone interview from his office in Geneva.

"It will help AIDS treatment programs everywhere," Piot said.

Reducing the cost of anti-retroviral drugs is only one step in stopping the AIDS epidemic. Other major obstacles include distribution of the drugs to areas that are accessible only on foot or by bicycle, lack of testing centers, rudimentary health care systems in much of the developing world, and inadequate medical staff.

From a public health perspective, Piot said, fixed-dose combinations should increase the availability of anti-retroviral drugs in such areas and be safer for patients. Taking one pill, or a small number of pills, he said, should increase patient compliance and help prevent development of resistant strains of HIV, the virus that causes AIDS.

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