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Mesothelioma: A Killer
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FDA eases rules on drug manufacturing
Last Updated: 2004-09-29 14:16:23 -0400 (Reuters Health)
WASHINGTON (Reuters) - Drug makers will not need regulatory approval for every change in their manufacturing processes under new guidelines designed to prevent supply disruptions, U.S. health officials said on Wednesday.
Companies can skip the prior approval requirement if they have developed adequate tests and procedures to show certain changes will not affect product safety or effectiveness, the Food and Drug Administration said in a report.
The modification is part of a just-completed, two-year effort to overhaul regulation of pharmaceutical manufacturing, a major issue for drug makers.
In the past, Schering-Plough Corp., Eli Lilly and Co. and other companies had trouble meeting federal production standards and faced delays in the approval of new medicines.
Some critics said the changes amounted to decreased regulation that could harm patients if problems were not uncovered before medicines were released to the public.
"I don't think it's a good idea. From a patient perspective, it is questionable and intermittently dangerous," said Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, a consumer group.
Health and Human Services Secretary Tommy Thompson, in a statement, said the FDA's plan would ensure "consistently high quality" for the U.S. drug supply.
The FDA said the new measures would help drugs get on the market quicker and prevent supply shortages or disruptions. The agency also wants to encourage companies to adopt new technologies.
"In the past, as a result of the many uncertainties in drug manufacturing, the FDA exercised extensive control over virtually every aspect of the manufacturing process," the FDA report said.
"Consequently, pharmaceutical companies have often been reluctant to change their manufacturing processes and equipment because of perceived, and sometimes real, regulatory hurdles."
The new system will focus inspections on plants that produce medicines with the most potential to harm patients if quality control lapses occur. Companies with effective quality control systems in place will be subject to fewer and less extensive inspections, the FDA said.
Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
Ethiopia church says condoms unchristian
Last Updated: 2004-09-28 15:32:46 -0400 (Reuters Health)
ADDIS ABABA (Reuters) - Condoms should not be used to fight HIV/AIDS as they are unchristian and unreliable, according to an influential church in Ethiopia, where 1,000 people are infected daily.
"Our church does not condone the campaign to use condoms against HIV/AIDS because such practices are unchristian and are not permitted under the ethics of the Orthodox Church," a church leaflet distributed this week said.
"We teach that a couple should be faithful to each other and avoid multiple partners, which is the major cause of HIV/AIDS infection," the leaflet said. "Furthermore the use of artificial material such as condoms is not reliable and could also undermine the campaign against HIV/AIDS," it added.
About 3 million of Ethiopia's nearly 68 million people are already infected with HIV/AIDS, one of the world's largest caseloads, and the Health Ministry estimates that about 1,000 people are infected daily.
The Orthodox Church says about 60 percent of the population are members of its congregation.
Condoms are widely available in Ethiopia. A packet of three costs 0.25 Ethiopian Birr (0.03 of a U.S. cent).
The government has promoted testing centers and media awareness campaigns in recent months, but analysts say the measures have as yet not reduced the number of infections.
($1=8.6 Ethiopian birr)
Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
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