Featured Issue Briefs
The Battle on the Home Front: Jonathan Gadsden's Story
Marine Lance Corporal's story reflects the growing need for new antibiotics that can treat dangerous diseases, against which most drugs are useless. Read More
Facilitating Medical Device Innovation: De Novo Reform
The de novo process -- which requests lower-risk reclassification of medical devices and entry into the marketplace -- as it exists now is not achieving its purpose and has instead added unnecessary and time-consuming requirements. Read More
Food Products Recalled by FDA
Since President Obama signed the FDA Food Safety Modernization Act into law, at least 149 FDA-regulated food products have been recalled due to potential pathogenic contamination. Read More
More Issue Briefs
| Date | Issue Briefs | Topic |
|---|---|---|
| Apr 25, 2013 |
Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification SystemThe three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database. More info |
Drugs and Devices at the FDA |
| Feb 5, 2013 |
Comments on the Health Information Technology Patient Safety Action and Surveillance PlanIn comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care. More info |
Drugs and Devices at the FDA |
| Jan 15, 2013 |
Comments on Stage 3 of the the Meaningful Use of Health Information TechnologyIn comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives. More info |
Drugs and Devices at the FDA |
| Nov 21, 2012 |
Strengthening Our National System for Medical Device Postmarket SurveillanceThe Medical Device Initiative submitted comments to the U.S. Food and Drug Administration concerning the FDA's National Medical Device Postmarket Surveillance Plan, "Strengthening Our National System for Medical Device Postmarket Surveillance." More info |
Drugs and Devices at the FDA |
| Nov 8, 2012 |
Pew Comments to the FDA Regarding the Unique Device Identification SystemPew’s Medical Device Initiative, along with the American Heart Association and Trust for America’s Health, submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule for a unique device identification (UDI) system for medical devices. Once implemented by the FDA and utilized by healthcare providers, the UDI system will be the cornerstone for significant improvements in postmarketing surveillance of medical devices. More info |
Drugs and Devices at the FDA |
| Jun 7, 2013 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| May 23, 2013 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| Apr 25, 2013 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| May 16, 2012 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| May 16, 2012 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| Mar 8, 2012 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| Feb 1, 2012 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| Sep 14, 2011 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| Aug 3, 2010 |
Drug Safety and Accountability Act of 2010The Drug Safety and Accountability Act of 2010 (S.3690) seeks to strengthen industry standards to ensure the quality and safety of drugs made for the U.S. market, and to improve the U.S. Food and Drug Administration’s (FDA) oversight abilities through modernized information systems and new authorities, such as the power to order a drug recall. More info |
Drug Manufacturing and Distribution, Drug Safety |
| Mar 10, 2010 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
