June 16, 2004
"On the Mend"
Cipla Chair Dr. Yusuf Hamied said that the removal of the drugs stemmed from "inadequate record keeping in the testing laboratory," according to the Times. He added that the company's generic version of lamivudine had undergone bioequivalency tests in a U.S. laboratory in anticipation of applying to FDA to sell the drug when the U.S. patent expires in 2006, according to the Times. Cipla said that the situation is "on the mend" and that it expects to have the medicines relisted with WHO within a few weeks, the Times reports. Rago said that delisting the two medicines would not affect WHO's 3 by 5 Initiative to treat three million people with antiretroviral drugs by 2005, the Times reports (New York Times, 6/16). Hudson Institute Senior Fellow Carol Adelman and adjunct fellow Jeremiah Norris said in a statement that WHO should "be applauded for taking these responsible steps on behalf of AIDS patients" because "[d]eficient products can catalyze a serious public health concern specifically by promoting HIV resistance." They added that WHO should "use this delisting experience to develop recall procedures for the products it had prequalified whenever that becomes necessary," saying that the agency could "reevaluate its entire prequalification program" (Hudson Institute release, 6/15).
Join kaisernetwork.org on Wednesday for a session of "Ask the Experts" featuring a panel discussion of low-cost antiretroviral drugs, including generic drugs. Call toll-free at 1-888-KAISER8 (524-7378) during the scheduled showtime or submit your questions to email@example.com before and during the discussion. The panel will include Jennifer Kates, director of HIV Policy at the Kaiser Family Foundation; Dr. David Hoos, assistant professor at Columbia University Mailman School of Public Health; and Dr. Mark Dybul, deputy chief medical officer in the Office of the U.S. Global AIDS Coordinator.
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.