"House lawmakers said they will continue efforts to narrowly tailor antibiotic incentives and clarify an online pharmacy measure before the full Energy and Commerce Committee takes up FDA user fee legislation that gained bipartisan subcommittee backing Tuesday morning, with stakeholders also continuing to push for changes to drug shortage and medical device measures. The health subcommittee quickly passed the legislation with only one amendment making technical changes to the revised bill released Friday (May 4), but lawmakers said tweaks in the two areas are possible prior to full committee markup Wednesday (May 9).
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Allan Coukell, director of medical programs for the Pew Health Group, also encouraged "a continued effort to ensure that this incentive will squarely target the development of the drugs patients need most -- those used to treat serious or life-threatening disease," outlining his concerns in a letter sent Monday (May 7) to health subcommittee leadership. Consumer, safety and public health advocates had urged House Energy and Commerce leadership in March to narrow legislation incentivizing antibiotic development to only include drugs that address the greatest public health need."
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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.
More infoThe 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.
More infoThe 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
More infoIn 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"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."
More info"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."
More infoMedical 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.
More infoIn 2007, an agency panel found that the FDA’s "scientific workforce does not have sufficient capacity and capability" and the agency is "not positioned to meet current or emerging regulatory responsibilities." The Pew Charitable Trusts wanted to know if that’s still the case, and asked the Partnership for Public Service to find out. "FDA has made progress," says the Partnership’s report, but the agency "continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed."
More infoThe 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 infoPew’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"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."
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