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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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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Testimony of Allan Coukell, Director of the Pew Prescription Project, on Protecting Consumers from Adulterated DrugsProtecting consumers against the risk of adulterated products is, of course, the original mission of the FDA. Today, the vast majority of pharmaceutical products sold in the United States today are not adulterated, but an increasingly complex supply chain creates new challenges and new risks – as recent events demonstrate. 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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Testimony of Allan Coukell before the Committee on Health Education Labor and Pensions, United States Senate"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.'" More info |
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Testimony of Allan Coukell before the Committee on Energy and Commerce, Subcommittee on Health, United States House of Representatives"Pew has been working to identify the risks to the drug supply and advance pragmatic solutions. In July of 2011, we released a report entitled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." More info |
Issue Brief |
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 |
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 before the Committee on Energy on Commerce, Subcommittee on Oversight and Investigations, United States House of Representatives"Chairman Stearns, Ranking Member DeGette, and members of the Oversight and Investigations 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..." 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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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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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 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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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 Statement on Energy and Commerce Drug Safety Hearing"Two years after dozens of Americans lost their lives to contaminated heparin, we are still unable to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health." 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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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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