Foreign drug manufacturing, testing raise regulatory and ethical concerns

Aug 25 2011

JAMA discusses "a recent report from the Pew Health Group about the growing risks of substandard and counterfeit medications resulting from the increasing overseas production of pharmaceuticals and their ingredients." According to JAMA, "The report notes that the U.S. Food and Drug Administration (FDA) now estimates that as much as 40 percent of pharmaceuticals used by U.S. consumers are made in other countries, and 80 percent of active ingredients and bulk chemicals used in drug manufacturing come from foreign countries." The report "recommends that pharmaceutical companies exert tighter control over their international suppliers, that Congress provide the FDA with more resources and greater authority to oversee foreign drug production, and that a universal system be created to track drugs from production to the pharmacy," the journal writes (Kuehn, 8/24).

In related news, PBS NewsHour interviewed Arthur Caplan, director of the Center for Bioethics at University of Pennsylvania's Perelman School of Medicine, who addressed the increasing trend "of holding clinical trials in developing countries and the ethical issues raised by this research trend" (Miller, 8/23).