Testimony of Allan Coukell before the Committee on Health Education Labor and Pensions, United States Senate

"Chairman Harkin, Ranking Member Enzi and members of the HELP Committee, thank you for the opportunity to testify about the essential steps Congress must take to protect Americans and ensure the integrity of our drug supply.

The Pew Charitable Trusts is driven by the power of knowledge to solve today's most challenging problems. Pew applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. Based on research and critical analysis, the Pew Health Group seeks to improve the health and well-being of all Americans.

A major focus of the Pew Health Group is identifying ways to improve the safety of the U.S. pharmaceutical supply chain. In July of this year, we released a report entitled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.” The report, which underwent extensive external review, was based upon information from regulatory and public documents, peer-reviewed journal articles and interviews with dozens of supply chain experts from numerous perspectives. It was informed by a two-day conference we hosted earlier this year that included representatives of brand and generic pharmaceutical manufacturers, active drug ingredient makers, major and secondary pharmaceutical wholesalers, chain and independent pharmacies, consumer and health professional organizations, the U.S. Food and Drug Administration (FDA), state regulators and independent supply chain experts. I am including the report as part of my testimony.

The key message is that pharmaceutical manufacturing has changed dramatically over the past decade. While the vast majority of drugs in American pharmacies and medicine cabinets are not counterfeit or adulterated, increasing globalization and reliance on outsourced manufacturing creates new risks, including the risk of deliberate tampering or counterfeiting of ingredients as well as the risk of inadequate safety or quality controls in a manufacturing environment that is largely outside the scrutiny of the FDA. Along with some serious recent safety problems, we have seen recently seen shortages of important medicines, in part due to manufacturing quality problems."