Government regulators and pharmaceutical companies are moving to address a major new risk for the global supply of medicines: The possibility that unsafe ingredients are entering the supply chain as pharmaceutical companies increasingly outsource the production of drug ingredients to third parties. That’s the topic of the cover story in the current edition of Chemical & Engineering News (C&EN), ACS’ weekly newsmagazine.
C&EN Senior Editor Rick Mullin explains that the jolt for action came from several incidents. One incident — a major 2008 recall of contaminated heparin that likely caused 81 deaths in the U.S. In another incident, more than 300 people died in Panama after taking cough medicine manufactured with diethylene glycol that was shipped by a supplier as glycerin.
The story describes awareness within the U.S. Food and Drug Administration (FDA) that rampant globalization in drug manufacturing has outstripped the agency’s resources for inspecting foreign facilities. FDA has responded by establishing an information sharing network with European, Japanese, and Australian regulators and has opened regional offices in Asia and elsewhere.