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 |
|---|---|---|
| Jul 8, 2013 |
Letter from Pew and Premier to the OMB on Unique Device Identifier RuleThe Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule. More info |
Drugs and Devices at the FDA |
| Jun 27, 2013 |
Letter from Pew: Release of the Unique Device Identifier Final RuleA letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system. More info |
Drugs and Devices at the FDA |
| Jun 26, 2013 |
Drug Development for Limited Populations: A New Proposed PathwayThe lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent. More info |
Antibiotic Innovation |
| Jun 18, 2013 |
Letter from Pew: Updates on the Unique Device Identifier SystemA letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system. 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 30, 2013 |
Letter from Pew to CMS Regarding Physician Payments Sunshine ActPrescription project director Danny Carlat identifies issues with the Physician Payments Sunshine Act requiring further clarification and guidance. Addressing those would ensure that manufacturers can appropriately implement the final rule, and enable consumers to benefit from transparency reports published by the Centers for Medicare & Medicaid Services. More info |
Conflicts of Interest |
| May 30, 2013 |
Letter from Pew to FDA on Postmarket Surveillance PlanFDA recently updated the national medical device postmarket surveillance plan – listing device identification and registries as the cornerstones for effective product monitoring. In this letter, medical devices director Josh Rising applauds the agency for making unique device identifiers and registries central to this plan. |
Drugs and Devices at the FDA |
| 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 |
| May 21, 2013 |
Bibliography on Antibiotic Resistance and Food Animal ProductionThis bibliography lists the latest published scientific and economic literature concerning the contribution of routine antibiotic use in food animals to the growing public health crisis of human antibiotic resistance. Research on how antibiotic use in food animal production contributes to the growing health crisis of antibiotic resistance dates back more than 30 years. More info |
Antibiotics in Food Animal Production, Moms For Antibiotic Awareness |
| May 9, 2013 |
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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| 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 |
| 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 |
| Apr 10, 2013 |
Antibiotics and Industrial Farming 101Each year, tens of thousands of Americans die and hundreds of thousands are hospitalized because of bacterial infections resistant to antibiotics. Antibiotic overuse on industrial farms is a big part of the problem. The largest U.S. meat and poultry producers feed antibiotics to healthy animals over much of their lives to make them grow faster and to compensate for the overcrowded and unsanitary conditions in which they are bred and slaughtered. More info |
Antibiotics in Food Animal Production |
| Apr 9, 2013 |
Pew Comments on Centers for Medicaid and Medicare Services' Information Collection Activities Draft GuidanceThe Pew Charitable Trusts appreciates this opportunity to submit comments to CMS's "Information Collection Activities" draft guidance. We suggest that both the research and non-research payment templates be modified in order to make it easier for consumers to identify which drugs, devices, biologicals, or medical supplies are associated with particular transfers of value. More info |
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| Apr 8, 2013 |
Multiple Organizations - Including Pew - Support DATA ActOn behalf of the undersigned organizations representing medical, public health, scientific, agricultural, environmental, animal protection, and other organizations, we urge you to include H.R. 820, the Delivering Antimicrobial Transparency in Animals (DATA) Act, as part of the final Animal Drug User Fee Act (ADUFA). This legislation provides a reasonable, common-sense approach to better understanding antibiotic use in agriculture. More info |
Antibiotics in Food Animal Production |
| Apr 4, 2013 |
Pew Comments on Draft Recommendations for Meaningful Use, Stage 3The Pew Charitable Trusts submitted comments on preliminary recommendations regarding Stage 3 meaningful use objectives and standards for electronic health records (EHRs) to the Office of the National Coordinator for Health Information Technology. These comments follow remarks at recent meetings of the Health Information Technology (HIT) Policy Committee and HIT Standards Committee. More info |
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| Mar 20, 2013 |
Washington Food Leaders Urge Sen. Murray to Shine a Light on Industrial Farms' Antibiotic UseSixteen of Washington state’s most celebrated chefs, farmers, and other food leaders wrote a letter to Senator Patty Murray, member of the Senate HELP Committee, asking to reauthorize the Animal Drug User Fee Act and include in it provisions to help preserve the efficacy of antibiotics vital to protecting public health. More info |
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| Mar 15, 2013 |
Groups Urge Obama to Take Action Against Drug-Resistant BacteriaPew and 46 other public health, medical, environmental and consumer leaders urged President Obama to take swifter action to protect the public from drug-resistant bacteria. In a joint letter, they call on his administration to eliminate industrial farms’ non-therapeutic use of medically important antibiotics and to support legislation that requires the Food and Drug Administration to shine more light on farming practices that are breeding superbugs. More info |
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| Feb 26, 2013 |
Health, Science Leaders Call on Congress for More Antibiotics DataA broad coalition of medical, public health, scientific, agricultural, consumer, environmental and humane organizations, representing more than 11 million supporters, wrote a letter urging Congress to reauthorize the Animal Drug User Fee Act (ADUFA) and include in it provisions to help preserve the efficacy of antibiotics vital to protecting public health. More info |
Antibiotics in Food Animal Production |
| 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 29, 2012 |
Letter From Pew and Medtronic to HHS Regarding the Physician Payments Sunshine ActThe Pew Health Group and Medtronic, Inc. file a joint letter to the U.S. Department of Health and Human Services urging implementation of the Physician Payments Sunshine Provision, which will require that manufacturers of drugs, devices,biologics or medical supplies report to the agency payments made to physicians and teaching hospitals. More info |
Medical Safety |
| Nov 21, 2012 |
Pew Comments on Advance Notice of Proposed Rulemaking ''Antimicrobial Animal Drug Sales and Distribution Reporting''The Pew Campaign on Human Health and Industrial Farming submitted a letter to the U.S. Food and Drug Administration, urging the FDA to strengthen regulations pertaining to record-keeping and public reporting of antibiotic use in food animal production. More info |
Antibiotics in Food Animal Production |
| 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 19, 2012 |
Public Health and Consumer Groups Call for Participation in Antibiotic Use MeetingsOn Nov. 2, 15 public health and consumer organizations sent a joint letter to the FDA requesting to join in discussions to consider how the misuse and overuse of antibiotics in livestock and poultry are significant contributing factors to antibiotic resistance in humans. More info |
Antibiotics in Food Animal Production |
