AIDS Drug Delivery To Be Hastened

The U.S. government Sunday promised to provide lifesaving combination drugs at lower prices to millions of people suffering from AIDS in Africa and the Caribbean.

"We are clearing the way to quickly deliver quality, lifesaving HIV/AIDS drugs to people who desperately need them in developing countries," U.S. Health and Human Services Secretary Tommy Thompson told reporters in Geneva, where he is attending a World Health Organization meeting.

The U.S. Food and Drug Administration next week will propose new guidelines to ease the approval process for products which combine several expensive treatments already approved individually by the FDA, making it easier for patients in developing countries to receive the treatments.

This marks a significant change in U.S. policy, which had been in favor of more stringent standards for these "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.

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.

"The President (Bush) has made clear that his goal is to put effective treatment into the hands of those who need it in the hardest-hit developing nations," said Randall Tobias, co-ordinator of the Bush administration's activities to combat AIDS. "At the same time, we must apply real discipline to ensure that the products we provide in poor nations are safe and effective.

"The new expedited process provides us with a solid foundation for purchasing drugs that work. With FDA review, we will have a gold-standard assurance that a combination product will be safe and effective."

Drug patent issues that apply in developed countries shouldn't impede purchase of those drugs for developing countries, Thompson added .

Both brand-name manufacturers and foreign generic makers can apply. 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.

Thompson was announcing a review of President George W. Bush's $15 billion emergency plan for AIDS relief — announced in Bush's January 2003 State of the Union address — to ensure that the United States is providing safe and effective drugs to 14 of the worst affected countries, 12 of which are in Africa and two in the Caribbean.