AEGiS-WSJ: U.S. Says 3-in-1 AIDS Drugs For Poor Nations Need Review

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

U.S. Says 3-in-1 AIDS Drugs For Poor Nations Need Review

Wall Street Journal - May 17, 2004
Sarah Lueck, sarah.lueck@wsj.com

WASHINGTON - The Bush administration said 3-in-1 AIDS drugs must win Food and Drug Administration approval before the U.S. buys them for developing countries, prompting criticism from advocacy groups who called the process an unnecessary barrier.

FDA officials said the process would be simple and speedy, perhaps taking four to six weeks once an application is complete. They also said companies in India already making the combination drugs would be eligible to win FDA "tentative approval'' recognizing their safety and effectiveness, even though they couldn't be sold here due to patent protections.

Further, the expedited process would increase the pressure on brand-name drug makers to formulate their own combination treatments and cause them to reduce their prices, officials said. And the FDA is instructing companies on what they need to do to win approval for co-packaging three separate AIDS drugs, a more likely near-term option.

"We will create a level playing field for all companies willing to submit applications for review," said Health and Human Services Secretary Tommy Thompson.

"We've been pressing to have an expedited system," said Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, a recipient of administration treatment funds.

Some AIDS advocacy groups said the combination drugs, already being used in sub-Saharan Africa, shouldn't be required to clear any FDA hurdles. The groups have pressed the administration to buy the cheaper Indian-made treatments, which received "pre-approval" from the World Health Organization.

Requiring the drugs to get FDA approval is "a dangerous precedent, in our estimation," said Paul Zeitz, executive director of the Global AIDS Alliance. "While this sounds like a fast-track, it's a delay."

William Haddad, speaking for Bombay-based Cipla, one of the Indian companies that makes a combination AIDS drug, said the process is "unnecessary, it's unwarranted, and we think it's a political act." He thinks the approval process will take longer than a few weeks.

A U.S purchase of the Indian-made drugs would have been problematic for the brand-name drug industry, which is fighting a domestic political battle against allowing prescription drugs to be imported from other countries where they are cheaper. U.S. endorsement of WHO "pre-approval" would have lent credibility to a process that is encouraging the use of copies of branded drugs.

Bush administration officials said they want to ensure safety and quality of drugs bought for international use, not reacting to drug-industry pressure.

Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co. Inc. said that they are in discussions on the development of a combination drug that would combine three separate AIDS drugs that they make. The companies said they are working on co-packaging the drugs. One component can cause birth defects, so it won't be suitable for pregnant women, unlike the Indian-made combination drugs.

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