Bush Administration Must Ensure Quality of Generic Drugs if Used in Global AIDS Treatment Programs, Opinion Piece Says
If the Bush administration decides to buy generic antiretroviral drugs for treatment programs in its global AIDS initiative, it should ensure that the drugs are the "bioequivalent to branded drugs," Roger Bate, a visiting fellow at the American Enterprise Institute and director of Africa Fighting Malaria, writes in a Business Day opinion piece. A "genuine" generic drug is the bioequivalent of and should be "indistinguishable" from a branded drug, which means that doctors can expect it to perform just as well, Bate says. However, some groups, such as Medecins Sans Frontieres, have been prescribing "without recourse to a separate authority" -- such as the FDA or World Health Organization -- "cop[ies]" of branded drugs, which Bate says are "not the same as a generic." Although these drugs simplify treatment guidelines and "could be as good as those passing FDA regulations, ... the certainty is lower," Bate says. Treating patients with these "less certain" drugs presents three main problems: "it may enhance drug resistance if formulations are not as good; second-line treatments (with newer and more costly drugs) will have to be brought on-line sooner, increasing overall costs; and if resistance builds up, doctors won't know if the drug is less effective, or if its formulations are just incorrect, so useful drugs may be discarded too early," Bate says. For example, resistance to first-line antiretroviral treatment regimens in MSF treatment programs "has built up relatively quickly," which is "indicative, but not conclusive, evidence" that the unapproved "copy" drugs they are using could be inferior, Bate writes. Although "[c]utting corners when millions of people have a disease is understandable," it is important that if the Bush administration opts to provide generic antiretroviral drugs, it ensures that they are "bioequivalent to branded drugs, and not something different," Bate concludes (Bate, Business Day, 10/30).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.