Letter from Pew: Updates on the Unique Device Identifier System
A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.
More infoAllan Coukell, director of medical programs at the Pew Health Group, appeared on C-Span to talk about drug safety. Recently, the House passed the Food and Drug Administration Reform Act of 2012 by a vote of 387-5. This legislation gives the FDA the funding it needs to approve new drugs and medical devices more quickly and improves inspection. The Senate passed a similar bill and a final draft of legislation is expected early the next month. Mr. Coukell responded to telephone calls and electronic communications."
A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.
More infoPew 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 infoRepresentative 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.
More infoOn 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.
More info''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."
More info"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."
More info"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."
More info"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."
More info"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."
More infoThe 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 infoWhen a doctor sticks a needle in you, you expect that the drugs it carries won’t be tainted. But, possibly owing to a strange gray area in federal law, thousands of patients last October got injections for back pain that contained highly dangerous fungal meningitis, and dozens of them died. Members of the Senate Health, Education, Labor and Pensions Committee are now seeking to fix the government’s oversight of the obscure world of compounding pharmacies. The reforms they want are overdue.
More infoThe U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers of medical devices, with certain exceptions, to place a unique identifier on the label of medical devices. Some medical devices would also need to be directly marked with the unique identifier.
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