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 |
|---|---|---|
| Nov 19, 2009 |
Regulatory Comment on Credit Card Disclosure RequirementsThe Pew Safe Credit Cards Project submitted comments (PDF) to the Federal Reserve Board regarding the Board’s latest proposed rulemaking under Regulation Z (Docket No. R—1370). The rules implement provisions of the Credit CARD Act of 2009 that are effective February 22, 2010. Pew’s comments focused on clarifying the rights of consumers in a credit card contract and increased responsibility for and disclosure from credit card issuers. More info |
Credit Cards |
| Sep 21, 2009 |
Regulatory Comment on Credit CARD Act Rule: Advanced Notice and Cancel RequirementsThe Pew Safe Credit Cards Project submitted comments (PDF) to the Federal Reserve Board regarding the Board’s interim final rules under Regulation Z (Docket No. R-1364). The rules cover advance notice and right to cancel requirements under the Credit CARD Act of 2009. Pew’s comments focused on a number of exceptions the Board proposed, which could allow issuers to raise interest rates, change minimum required payment levels and impose potentially large deferred interest charges with little or no advance warning. More info |
Credit Cards |
| Jun 25, 2009 |
Regulatory Comment on Credit CARD Act Reasonable and Proportional RuleThe Pew Safe Credit Cards Project submitted comments to the Federal Reserve Board in regard to rulemaking under the Credit CARD Act of 2009. These comments focused specifically on the law’s requirement that penalty fees and charges must be reasonable and proportional to related cardholder omissions or violations. More info |
Credit Cards |
| May 20, 2009 |
Curing Credit Card PenaltiesCongress is set to enact new legislation that will make credit cards safer and more fair for consumers. As lawmakers negotiate final details before President Obama can sign the bill, new analysis from the Pew Health Group highlights the importance of a safeguard found only in the Senate’s version of the law. More info |
Credit Cards |
| Oct 3, 2008 |
Safe Credit Card Project Regulatory Comment:In October 2008, the Pew Safe Credit Cards Project shared comments (PDF) based on its recent work on credit cards with the Federal Reserve. Select findings from the project—including information on credit card penalty re-pricing and analysis of credit cards in the market—were included. More info |
Credit Cards |
| 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 |
| Jun 10, 2009 |
FDA Globalization Act of 2009: Drug Safety ProvisionsThe Food and Drug Administration Globalization Act of 2009 (H.R.759) seeks to secure the safety of imported prescription drugs and active pharmaceutical ingredients through greater FDA authority and manufacturer responsibility, and increased inspections of prescription drug and active pharmaceutical ingredient manufacturing sites abroad. More info |
Drug Manufacturing and Distribution, Drug Safety |
| May 1, 2009 |
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 |
Drug Manufacturing and Distribution, Drug Safety |
| Jul 25, 2012 |
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 |
Drug Safety |
| Apr 18, 2012 |
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 |
Drug Safety |
| Apr 13, 2011 |
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 |
Drug Safety |
| Jul 10, 2009 |
Bill Comparison - Regulation of Overseas Drug ManufacturingThis issue brief from the Pew Prescription Project outlines the differences between bills from the U.S. House of Representatives and the U.S. Senate regarding regulation of overseas drug manufacturing. More info |
Drug Safety |
| Mar 29, 2012 |
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 |
Drug Safety, Drugs and Devices at the FDA |
| Aug 3, 2010 |
Americans' Attitudes on Prescription Drug SafetyThis issue brief presents key findings from a nationwide survey about the safety of the U.S. drug supply among voters conducted March 29 –April 1, 2010 for the Pew Prescription Project by Hart Research Associates Public Opinion Strategies. More info |
Drug Safety, Medical Safety Policy |
| Jul 2, 2009 |
Bill Summary - Counterfeit Drug Enforcement Act of 2009This issue brief is a summary of H.R. 2726 - The Counterfeit Drug Enforcement Act of 2009, also known as the Tim Fagan Law. More info |
Drug Safety, Medical Safety Policy |
| 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 |
