[Ip-health] WSJ: White House Aims to Answer Critics of Its AIDS Fight

[Mike Palmedo]

http://online.wsj.com/article/0,,SB108320263522496959-search,00.html?collection=autowire%2F30day&vql_string=aids%3Cin%3E%28article%2Dbody%29

White House Aims To Answer Critics Of Its AIDS Fight

By SARAH LUECK
WALL STREET JOURNAL
April 29, 2004; Page A9

WASHINGTON -- The Bush administration is working to develop a speedy
approval process for combination AIDS treatments that could be used in
developing countries, senior officials say.

The administration hopes to calm a controversy over whether it will
allow its multibillion-dollar global AIDS fund to be spent on cheaper,
foreign-made combination products. Under the new process, the makers of
those products and brand-name pharmaceutical companies ostensibly would
be able to go through the Food and Drug Administration, which would take
one or two months.

For now, recipients of the U.S. funds are being told to buy only
brand-name products. AIDS advocacy groups and the Indian companies that
make the combination drugs, citing their lower cost and ease of use,
have pressed the Bush administration to buy them. But brand-name
pharmaceutical makers have opposed the use of the drugs, which are
copies of their patented products. U.S. officials raised questions
recently about whether the drugs are safe and effective and said they
need more information before making a decision.

The FDA is working on guidance to explain its approval process to
companies, a senior FDA official said.

"The Indian companies can apply to the FDA for approval for their new
HIV drugs, and if the data they submit shows that these drugs are safe
and effective, FDA could approve them," said a senior FDA official, who
spoke on the condition of anonymity. "As a practical matter, the Indian
companies would probably be free to market these drugs in Africa, since
the innovator companies have already said they would not enforce their
patents in that continent."

No brand-name companies currently make the combination drugs at issue,
but the FDA process could pave the way for that to happen rapidly. The
guidance will also explain how the three drugs that make up the
combination treatments -- which are made by three different brand makers
-- could be packaged together for easier delivery.

Administration officials said the expedited approval process is one
option being considered as they set up rules for what drugs recipients
of the global AIDS funds can purchase to treat patients in Africa. They
said they also are working with the World Health Organization, which
"pre-qualified" certain combination treatments for use in the developing
world, to get more data about the drugs that would allow them to get a
U.S. sign-off.

AIDS activists here and abroad have argued that the WHO review should be
sufficient.