After Heparin: - The Pew Charitable Trusts

Executive Summary
In late 2007, U.S. health officials began receiving reports of unexpected allergic-type reactions in patients
undergoing dialysis. 1 The reactions were linked to a widely used blood thinner—heparin 2 —and
specifically to an adulterant that had been introduced during manufacture of the drug in China. 3–5 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. 6
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. 7 The FDA estimates that up to 40 percent of finished drugs used by U.S. patients
is manufactured abroad, 8,9 and 80 percent of active ingredients and bulk chemicals used in U.S. drugs
comes from foreign countries. 10 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.
For economic reasons, the movement of manufacturing from the United States to foreign countries is
likely to continue. However, industry and regulatory bodies have failed to adapt adequately to these
changing circumstances.
Drawing on public documents, peer-reviewed publications and dozens of interviews with industry stakeholders,
regulators and supply chain experts, this Pew Health Group white paper provides an overview
of the complex, modern pharmaceutical supply chain and its risks from manufacturing through distribution
of the finished drug. A discussion draft of this document was developed to inform a Pew Health
Group stakeholder conference on ensuring the safety of the U.S. drug supply that was held on March 14
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 7