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.
More infoPublic 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 infoAn 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. 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 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 info"The deaths and illnesses linked last fall to a New England pharmacy operating in the regulatory shadows as a cut-rate drug manufacturer is one of the biggest pharmaceutical public health disasters in American history."
More infoThe Pew Charitable Trusts has identified 20 pharmacy compounding errors associated with 982 adverse events, including 67 deaths, since 2001. Contamination of sterile products were the most common compounding errors, though some were the result of pharmacists’ and technicians’ miscalculations and mistakes in filling prescriptions.
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 infoRanbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted all production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.
More info''Drug and medical-device makers are bracing for a new U.S. rule that will require them to report physician-payment information to the government--a rule some companies and doctors fear will be overly broad and could mislead the public.''
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."
More infoThe Pew Charitable Trusts has identified 20 pharmacy compounding errors associated with 982 adverse events, including 67 deaths, since 2001. Contamination of sterile products were the most common compounding errors.
An overview of the complex pharmaceutical supply chain from manufacturing through distribution of the finished drug, and advances proposed policy solutions to help reduce the risks of counterfeit, adulterated and substandard drugs.
Allan Coukell
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
Gabrielle Cosel
Manager, Drug Safety
The Pew Charitable Trusts
Copyright(c) 1996-2012 The Pew Charitable Trusts. All Rights Reserved.
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