[e-drug] FDA and Generic AIDS Drug Approvals

e-drug
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E-DRUG: FDA and Generic AIDS Drug Approvals
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FDA To Share Confidential Information on Generic HIV/AIDS Drug Approvals With WHO; Deal Might Speed Drug Distribution
16 Aug 2005
<http://www.kaisernetwork.org>http://www.kaisernetwork.org.

FDA late last week announced it will share confidential information on its approvals of generic antiretroviral drugs with the... <http://www.who.int/en/&gt;World Health Organization, which might help accelerate the distribution of low-cost medications worldwide, the Boston Globe reports.
<http://www.boston.com/news/world/africa/articles/2005/08/14/accord_could_speed_distribution_of_generic_aids_drugs/&gt;

Since FDA implemented an expedited review process for generic antiretroviral drugs about one year ago, the agency has approved nine medications.
<http://www.state.gov/s/gac/&gt;

However, the President's Emergency Plan for AIDS Relief has not purchased the drugs because some African countries will not allow them to be imported without testing and approval from WHO. Under the agreement, FDA will ask generic drug companies if it can provide test results and inspection reports about their drugs to WHO, which then will examine the information and decide whether to include the drugs on its list of prequalified medications. Developing countries then could allow importation of the drugs, which would permit the U.S. to purchase and distribute the drugs.

The first U.S. purchases of generic antiretroviral drugs could arrive in countries in two to three months, according to the Globe. The agreement will "reduce the cost of AIDS drugs, and we also hope it decreases the confusion on the ground," WHO HIV/AIDS Programme Director Jim Yong Kim said.
<http://www.who.int/hiv/en/&gt;
<http://www.health.go.ug/National_drug.htm&gt;

Uganda National Drug Authority Chair James Makumbi -- who in June said he needed WHO to approve South African-made generic antiretrovirals before his board could consider them -- said the deal was "very good news," adding, "The absence of WHO approval has been the main hitch" in importing and distributing FDA-approved generic medications (Donnelly, Boston Globe, 8/14).

"Reprinted with permission from <http://www.kaisernetwork.org>

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