Governments, donors should follow PMI model of testing drugs for quality

"[W]e are losing the global fight against bad medicines," and though "[s]ome progress is being made," the "problem is that ... crackdowns tend to focus on counterfeit drugs" while a "much bigger public health problem ... is substandard drugs that are the result of shoddy manufacturing and handling -- or perhaps worse, deliberate corner-cutting," Roger Bate, a resident scholar at the American Enterprise Institute, writes in an opinion piece in The Hill's "Congress Blog." He continues, "In poor countries, a frightfully high number of bad drugs reach patients through legitimate supply chains and even donor programs underwritten by U.S. and European taxpayers," increasing the risk of harm to patients and the development of drug-resistant disease strains.

Bate describes some of his team's research, including a study published last week in Malaria World Journal that found "the U.S. President's Malaria Initiative (PMI) is the only donor program that effectively self-polices when it comes to drug quality." He continues, "That's a sharp contrast with other governments and multilateral donors like the Global Fund to Fight AIDS, Tuberculosis and Malaria, which outsources the job of assuring drug quality throughout the supply chain to the principal recipients of its grants." Bate says, "If we're going to make progress, donors need to copy the PMI and conduct pre-shipment testing of every batch of drugs provided to poor countries." In addition, he suggests that "[a]ny manufacturer found with failing batches of drugs on more than three occasions in a year ... not be eligible for tendering in the following year" and "[t]he U.S. should also make pre-shipment batch testing and post-market surveillance a condition of all drug-related aid, especially for the Global Fund." Bate concludes, "Because the U.S. is the leading donor to the Global Fund by far, demanding better drug surveillance would send a clear message both to the organization's new management and to other donor governments: it is time to take the global fight against substandard medicines seriously" (12/7).