Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
|
|
Wall Street Journal - April 29, 2004
Sarah Lueck, Staff Reporter of The Wall Street Journal
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.
Write to Sarah Lueck at sarah.lueck@wsj.com
040429
WB040404
Copyright © 2004 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from the Elton John AIDS Foundation, National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.
Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .