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Media Coverage
''User Fees Clear E&C, But Waxman, Consumer Advocates Still Seek GAIN Changes''
"As FDA user fee legislation heads to the House floor, a key Democratic lawmaker called for antibiotic incentive to be focused on serious and life-threatening infections and an HHS directive to work on stewardship programs while the lead sponsor of antibiotic incentives pushed back against attempts to change the incentive structure outlined in the Generating Antibiotic Incentives Now section of the bill.
. . .
Allan Coukell, director of medical programs for the Pew Health Group, said while there is a recognition that rapid diagnostics are an important tool in treating serious infections, the incentive was not appropriately tailored. 'That provision wouldn't have gotten us there,' he said, noting that the incentive applied to the drug company, not the diagnostic manufacturer.
Further, Pew prefers the language in the Senate bill because while it includes a list of qualifying pathogens, but it is "illustrative," Coukell said. It provides the incentive for products treating serious and life-threatening diseases, but is worded such that the drug does not have to treat a pathogen on the pathogen list, Coukell said.
'Antibiotics don't get approved for bugs they get approved for infections,' he said."
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The 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.
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A 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.
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'You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-changing, potentially lifesaving products made by the medical device industry. But chances are you or a family member will be a patient some day. That’s why it isn’t just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they’re on the market or in use."
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A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.
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FDA 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.
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The 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.
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This year's celebration of National Public Health Week (NPHW) focuses on the theme, "Public Health is ROI: Save Lives, Save Money." Join us in recognizing the work of Pew's Health Initiatives.
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The PBS program "Need to Know" devoted a portion of their March 22 program to discuss medical devices. Joining host Jeff Greenfield on the program was Pew's Dr. Josh Rising, project director of the medical devices initiative at The Pew Charitable Trusts.
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The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people. But hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing
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On Feb. 1, 2013, the Centers for Medicare & Medicaid Services published the final rule guiding implementation of the Physician Payments Sunshine Act, which Congress passed as part of the Affordable Care Act in March 2010 to increase transparency in the relationships between physicians and drug and medical device makers. Here are some of the highlights.
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In 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.
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"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."
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In 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.
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"Harmonizing conflict-of-interest standards will depend on the Centers for Medicare & Medicaid Services moving forward to implement the federal Sunshine law, which is now more than a year behind schedule. Industry, consumers and academic stakeholders are all waiting on CMS to issue a final rule."
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Medical devices range from common iteams such as stethoscopes to more complex products such as pacemakers and heart stents. The Medical Device Initiative project seeks to improve the tracking of medical device safety and to foster innovation that benefits patients. Project Director Josh Rising has a personal connection to the value of medical devices and he explains the importance of the Initiative and the goals of the program.
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