Issue Brief
Jul 25, 2012
Pew's Allan Coukell submitted a statement of record to the Congressional Committee on Commerce, Science and Transportation regarding concerns with the pharmaceutical supply chain. The focus of Coukell's testimony was the drug distribution system – the weaknesses in the system and the risks of counterfeit and stolen drugs. More info| Summary | Type |
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Pew Comment Letter to the Senate HELP Committee on Compounding LegislationPew 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 info |
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Pew Testimony: Examining Drug CompoundingOn 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. More info |
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Pew Testimony on the Safety of Compounding PharmaciesThe U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing on May 9 entitled "Pharmaceutical Compounding: Proposed Legislative Solution." Pew's Allan Coukell, a pharmacist and drug safety expert, testified on the need to strengthen oversight of the compounding industry. More info |
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Pew Comments to Senate HELP Committee on Drug Distribution SecurityThe Pew Charitable Trusts commented on the draft proposal to secure drug distribution in the United States. Although recognizing that the draft is the product of a sustained effort to address a complex system and balance sometimes competing imperatives, Pew shared areas of significant concern. More info |
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Pew Testimony to House Energy and Commerce Subcommittee on Health Regarding Drug Supply ChainThe House Energy & Commerce Subcommittee on Health will hold a hearing on April 25 entitled "Securing Our Nation’s Prescription Drug Supply Chain." Allan Coukell, a pharmacist and drug safety expert, will testify on the need to establish a national system to track and authenticate medicine. The principles outlined in his prepared testimony are supported by other stakeholders in statements from consumer, patient, public health, and industry groups. More info |
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U.S. Illnesses and Deaths Associated With Compounded MedicationsThe Pew Charitable Trusts has identified 20 pharmacy compounding errors associated with 1022 adverse events, including 75 deaths, since 2001. More info |
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Safety Problems at Compounding Pharmacies Confirm Need for Better OversightThe U.S. Food and Drug Administration late last week said it found widespread safety violations at more than two dozen specialized compounding pharmacies. The agency’s announcement comes after a nationwide outbreak of meningitis that killed more than 50 people and sickened hundreds who received contaminated injections made at a Massachusetts pharmacy. More info |
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National Public Health WeekThis year's celebration of National Public Health Week (NPHW) focuses on the theme, "Public Health is ROI: Save Lives, Save Money." Join us in recognizing the work of Pew's Health Initiatives. More info |
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Testimony of Allan Coukell Before the Committee on Commerce, Science and TransportationPew's Allan Coukell submitted a statement of record to the Congressional Committee on Commerce, Science and Transportation regarding concerns with the pharmaceutical supply chain. The focus of Coukell's testimony was the drug distribution system – the weaknesses in the system and the risks of counterfeit and stolen drugs. More info |
Issue Brief |
Heparin: A Wake-Up Call on Risks to the U.S. Drug SupplyWhile the vast majority of drugs in American pharmacies and medicine cabinets are safe, globalization and reliance on outsourced manufacturing creates new risks, including deliberate tampering with ingredients and inadequate quality controls in plants that operate largely outside the scrutiny of the FDA. More info |
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Case Studies: How Unsafe Drugs Can Reach PatientsThe following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform. More info |
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Testimony before the Committee on Energy and Commerce Subcommittee on HealthU.S. House of Representatives PDF Download Since 1992, user fee agreements have given FDA significant and sustained resources that allow the agency to review new products quickly. In fact, preliminary findings of a study that Pew has funded show that FDA reviews new drugs faster than its cou More info |
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Testimony before the Senate Committee on Health, Education, Labor and PensionsAllan Coukell, Director of Medical Programs, Pew Health Group: Chairman Harkin, Ranking Member Enzi, and members of this committee, thank you for the opportunity to testify about the importance of the user fee agreement legislation to patients. More info |
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Testimony of Allan Coukell on the Lack of a National Pharmaceutical Tracking SystemOn March 8, 2012, Pew Health Group’s Director of Medical Programs Allan Coukell testified before the Energy and Commerce Committee’s Subcommittee on Health regarding the drug distribution system – the risks of counterfeit and stolen drugs, and the pragmatic steps Congress can take to reduce those risks. More info |
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The Pew Charitable Trusts has identified 20 pharmacy compounding errors associated with 982 adverse events, including 67 deaths, since 2001. Contamination of sterile products were the most common compounding errors.
An overview of the complex pharmaceutical supply chain from manufacturing through distribution of the finished drug, and advances proposed policy solutions to help reduce the risks of counterfeit, adulterated and substandard drugs.
Allan Coukell
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
Gabrielle Cosel
Manager, Drug Safety
The Pew Charitable Trusts
Copyright(c) 1996-2012 The Pew Charitable Trusts. All Rights Reserved.
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