After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs

In late 2007, U.S. health officials began receiving reports of unexpected allergic-type reactions in patients undergoing dialysis. The reactions were linked to a widely used blood thinner—heparin—and specifically to an adulterant that had been introduced during manufacture of the drug in China. The U.S. Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the U.S. pharmaceutical supply chain.

Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors.

The number of drug products made outside of the United States doubled from 2001 to 2008, according to FDA estimates. The FDA estimates that up to 40 percent of finished drugs used by U.S. patients is manufactured abroad, and 80 percent of active ingredients and bulk chemicals used in U.S. drugs comes from foreign countries. Increasingly, the United States relies on drug manufacturing in developing countries—mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution and the existence of criminal actors willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients. As evidenced by the adulteration of heparin and other case studies outlined in this report, these rare but potentially serious events can have grave consequences.