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Donor Governments Need To Conduct More Post-Market Oversight Of Generic Medicines

The WHO and FDA approve drugs to treat malaria, tuberculosis and other diseases in low- and middle-income countries, but “some of the manufacturers, predominantly Chinese and Indian firms, may be knowingly producing” poor quality medicines, according to “the conclusion of my research teams’ studies, published this week in the journal Research and Reports in Tropical Medicine,” Roger Bate, resident scholar with the American Enterprise Institute and lead author of the studies, writes in a Washington Post opinion piece. “With little or no oversight, these companies may be cutting corners in the manufacturing process — or worse, watering down the active ingredient in their drugs, perhaps when the price of the raw material spikes and supply becomes harder to obtain,” he states, adding, “By exposing people to insufficient doses of the active ingredient, the drugs may also accelerate drug resistance and cause tremendous harm to whole populations in the long run.”

“To add insult to injury, some of the drugs we tested had been bought through Western donor programs, funded by taxpayers, and steered through aid programs to African markets,” Bate writes, continuing, “And our governments, which spend billions on aid programs designed to stop [malaria and tuberculosis], may inadvertently be causing harm by increasing access to substandard treatments.” He adds, “The reality is that once a manufacturer gets the green light to sell its drugs in Africa — sometimes through the lucrative donor programs — there are often no consequences for failing to maintain a high standard of quality.” Though the WHO has launched an investigation based on the studies’ results, “[d]onor governments should urgently step up post-market surveillance and increase penalties for repeat offenders,” Bate says, concluding, “If donor governments took drug quality as seriously in Africa as they do in their own countries, they could save lives and increase the impact of the public health programs taxpayers fund” (7/12).

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Filling the need for trusted information on national health issues, the Kaiser Family Foundation is a nonprofit organization based in Menlo Park, California.