Securing a Safe Drug Supply

In 2007 and 2008, patients in the U.S. died after receiving heparin, a widely used blood-thinner, all of whom suffered one or more symptoms associated with a known contaminant. The toxic ingredient was introduced during manufacture in China, and is believed to reflect deliberate use of a low-cost material in place of the pure drug.

The deaths highlight the risks of an increasingly complex and globalized pharmaceutical supply chain. A 2007 report by the U.S. Government Accountability Office estimated that 80 percent of the active ingredients in U.S. drugs are now made overseas, and that FDA has little ability to inspect foreign manufacturing sites. The true prevalence of contaminated, sub-potent or counterfeit medication is unknown. Risks exist within the supply chain at several levels, from the production of raw ingredients through to the point of retail sale.

The Pew Prescription Project works to encourage appropriate Congressional and regulatory responses to protect consumers and ensure the safety of the U.S. drug supply.

• After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs
• Bill Comparison: Regulation of overseas drug manufacturing: H.R.759 v S.882
• Bill Summary: Pharmaceutical Market Access and Safety Act of 2009
• Bill Summary: Counterfeit Drug Enforcement Act of 2009

• Testimony before the House Committee on Energy on Commerce, Subcommittee on Oversight and Investigations United States House of Representatives
• Americans' Attitudes on Prescription Drug Safety
• Pew Statement on Energy and Commerce Drug Safety Hearing
• Testimony of FDA Deputy Commissioner Joshua Sharfstein on Drug Safety before the House Energy and Commerce Subcommittee on Health
• Testimony of Allan Coukell, Director of the Pew Prescription Project, on Protecting Consumers from Adulterated Drugs

• The Drug Safety and Accountability Act of 2010
• Overview of Pharmaceutical Supply Chain Bills
• Food and Drug Globalization Act of 2009 (Drug Safety Provisions)