International Review System of Generic Antiretrovirals Would Ensure Safety, Efficacy and Supply, Opinion Piece Says
Although "nothing to date" has suggested that generic antiretroviral drugs on the World Health Organization's approved list of medications for HIV/AIDS patients are "ineffective," the "continuing criticism" of generics has created "a climate of uncertainty" about the safety and efficacy of the drugs, Kevin Frost, vice president of global initiatives at the American Foundation for AIDS Research, writes in an opinion piece in the journal Lancet (Frost, Lancet, 4/9). WHO in June 2004 removed from its list Indian generic drug maker Cipla's generic versions of the antiretroviral drugs lamivudine and zidovudine because of problems detected during an inspection of an independent laboratory Cipla hired to conduct bioequivalence tests. The drugs returned to the list in November 2004 after inspections proved they were bioequivalent to their brand-name counterparts, but WHO urged the manufacturers of all of the pre-qualified HIV/AIDS-related medicines to check data they have submitted. Indian generic drug companies Ranbaxy and Hetero Drugs in November 2004 removed a total of 13 generic antiretroviral drugs from the WHO list because of various discrepancies or deficiencies in the bioequivalence testing and data submitted (Kaiser Daily HIV/AIDS Report, 12/1/04). The "time has come" for an ongoing international market review of generics, "which would include a network of clinical facilities linked to laboratories able to evaluate drug quality," according to Frost. "[T]he absence of an independent review system for all HIV generics on the market has become an anachronism and a powerful impediment to humanitarian goals of treatment scale-up," Frost writes, adding, "[I]t is shameful not to put a system in place that would satisfy the desire to ensure safety and efficacy and treat the greatest number of people" (Lancet, 4/9)This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.