"Chairman Pitts, Ranking Member Pallone and members of the Health Subcommittee, thank you for the opportunity to submit testimony about the essential steps Congress must take to protect Americans and ensure the integrity of our drug supply.
Based on research and critical analysis, the Pew Health Group seeks to improve the health and well-being of all Americans by reducing unnecessary risks to the safety of medical and other consumer products and supporting medical innovation. Pew applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life.
The safety of the U.S. pharmaceutical supply system, a focus for Pew for the past four years, has also been a matter of sustained interest to this Committee. Nevertheless, many Americans would be surprised by the rapid and profound changes in how our prescription drugs are made – and the new risks that brings. Today, 40 percent of all finished pharmaceuticals, and 80 percent of the active ingredients and bulk chemicals in U.S. drugs, are now sourced by industry from foreign countries. Up to half are purchased from plants in India and China. The number of non-U.S. plants we depend on has doubled in just the past decade."
Download the PDF to read the complete testimony from Alan Coukell.
Pew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.
More infoRepresentative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.
More infoOn Thursday, May 23, the House Energy & Commerce Subcommittee on Health held a hearing, entitled "Examining Drug Compounding." Gabrielle Cosel, a drug safety expert, testified on the need to clarify oversight of compounding pharmacies on the state and federal level.
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Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
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