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 |
