Quality of Generic Antiretroviral Drugs ‘Vital’ to WHO 3 by 5 Initiative Success, Opinion Piece Says
Although the "odds" that the World Health Organization will meet its goal of treating three million HIV-positive people with antiretroviral drugs by the end of 2005 under its 3 by 5 Initiative have "improved significantly" with the availability of less-expensive generic antiretroviral drugs, the "confidence about the quality and effectiveness" of generic medications "remains a critical concern," an Akron Beacon Journal editorial says. The Bush administration does not purchase generic antiretrovirals that have not yet been approved by FDA, citing safety and quality concerns, even though WHO maintains a list of "qualified" generic drugs for use in developing countries, the editorial says. However, it is "disheartening" that WHO's "efforts to ensure quality and its goal to expand access to antiretroviral drugs could be set back by the shoddy testing and documentation of a major manufacturer," the editorial says, referring to the withdrawal of some medications from the list (Akron Beacon Journal, 11/12). Indian generic drug company Ranbaxy last week voluntarily removed all seven of its antiretroviral drugs from the WHO prequalification list after discovering discrepancies in tests conducted to determine whether its generic drugs were equivalent to brand-name versions of the same drugs. In August, WHO removed three generic Ranbaxy antiretroviral medications after inspecting a contract research organization that conducted tests to determine whether the medications were bioequivalent to the patented versions. WHO decided to remove the drugs after determining that the testing lab failed to meet international standards of clinical and laboratory practices (Kaiser Daily HIV/AIDS Report, 11/10). Generic drugs "are vital to WHO's big dream," the editorial says, concluding, "So is vigilance about quality" (Akron Beacon Journal, 11/12).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.