WSJ: US Says 3-in-1 AIDS Drugs for Poor Nations Need Review

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U.S. Says 3-in-1 AIDS Drugs

For Poor Nations Need Review

By SARAH LUECK

Staff Reporter of THE WALL STREET JOURNAL

May 17, 2004; Page B2

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

.

" We've been pressing to have an expedited system, " said Mark Isaac, vice

president of the 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 Zeitz, executive director of the Global AIDS

Alliance. " While this sounds like a fast-track, it's a delay. "

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.

Write to Lueck at sarah.lueck@...