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Media Coverage
''Let The Sunshine In: CMS Releases Transparency Rule''
"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.
The rule was created to address rising concerns that such financial relationships may unduly influence medical research and practice. For this reason, the release of the final versions marks a watershed moment in the ongoing effort by a wide array of organizations and individuals to force drug and device makers to become more transparent. Even small financial ties have been shown in studies to bias physicians (read more here)
The rule, which is part of the Affordable Care Act, requires manufacturers and GPO’s to post payments exceeding $10 to physicians and teaching hospitals on their web sites. This would pertain to consulting fees, food and beverages and research payments for instance. The data to be posted would also include all ownership or investment interests held by a doctor or family member. Penalties for violations can range up to $150,000 annually for failing to report data and $1 million if a company knowingly fails to report the information (here is the rule)."
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"The lack of transparency regarding payments made by the pharmaceutical and medical device community to physicians has created a culture that this law should begin to change substantially," says U.S. Senator Chuck Grassley who, along with former U.S. Senator Herb Kohl, introduced the original legislation. "The reform represented by the Grassley-Kohl Sunshine Law is in patients' best interests. I will stay vigilant about how this law is implemented, especially after the delays seen already. The goal is straightforward, and CMS needs to make certain the reporting and disclosure are complete and clear."
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"The failure to release the rule has frustrated not only drug and device makers and GPO’s, but also a wide array of consumer advocacy groups. Moreover, many organizations epxressed concern that the White House Office of Management & Budget's Office of Information and Regulatory Affairs might water down the rule because the same office gutted a key provision of the NIH conflict of interest rules.
"This rule allows a long-delayed transparency measure to take effect. Public reporting of the financial relationships between doctors and drug or medical device companies will protect patients and help restore trust in our healthcare system. We applaud the Centers for Medicare & Medicaid Services for issuing the Sunshine regulation, which will now allow manufacturers to comply with their reporting obligations under the law," says Allan Coukell, director of medical programs at Pew Charitable Trusts."
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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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Pew 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.
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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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Representative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.
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On 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.
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Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
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An Ohio legislator’s plan to establish a nationwide prescription drug tracking system to protect patients from fake drugs was approved by the House Commerce Committee.
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''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."
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"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."
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"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."
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"At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now."
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"State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications."
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