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Archive for Monday, May 17, 2004

U.S. drug companies pledge to work on new AIDS pill

May 17, 2004

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— Three major U.S. pharmaceutical companies said Sunday they'll work to develop a new combination AIDS drug offering a single daily dose, making for easier and lower-cost treatments for millions of people in Africa and the Caribbean.

The announcement came the same day the United States pledged to speed the review process for such drugs.

In a joint statement, Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co. Inc., said they will pursue research to combine three of their HIV medicines into a single tablet.

In Geneva, U.S. Health and Human Services Secretary Tommy Thompson said the Food and Drug Administration will propose new guidelines to ease the approval process for products which combine several expensive treatments already approved individually by the FDA. Patients in developing countries would then have easier access to the treatments.

"We are clearing the way to quickly deliver quality, lifesaving HIV/AIDS drugs to people who desperately need them in developing countries," Thompson said at a World Health Organization meeting.

The decision marks a significant change in U.S. policy, which had been in favor of more stringent standards for such "fixed-dose combinations," made by foreign companies which manufacture low-cost generic versions of anti-HIV drugs and combine them into single pills.

AIDS advocacy groups and some members of the U.S. Congress have criticized that policy as a front intended to ensure the sales of more expensive patented drugs, delaying if not blocking lifesaving treatments in regions hit hardest by the epidemic.

Globally, the disease affects about 40 million people, with nearly 30 million of them in Africa.

WHO has signaled which combinations are appropriate for use in its international push to get lower-cost HIV treatments to developing countries. The combination pills eliminate the need for patients to swallow multiple pills in treatment cocktails.

Both brand-name manufacturers and foreign generic makers can apply under the new guidelines. FDA approval for the foreign generics would not allow their sale in the United States because of patent laws, but would allow purchases for distribution in developing countries.

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