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November 14, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA, state regulators seek tighter oversight of drug compounders
    The FDA and state health regulators called for congressional action to bolster federal oversight of drug compounders as Congress prepared for hearings on a meningitis outbreak tied to the New England Compounding Center. "It is clear that the patchwork of disparate state regulations is not enough to keep the public safe," Massachusetts Department of Public Health interim Commissioner Dr. Lauren Smith wrote in prepared testimony filed with a House oversight panel. "FDA's authority over compounding pharmacies is more limited by law and needs to be strengthened," the FDA said. FDA Commissioner Dr. Margaret Hamburg is set to testify today. Reuters (11/13) Email this Story
  • What questions will come up in hearing on compounding?: Hearings begin today on the meningitis outbreak, and senators and representatives should be asking if compounding is truly necessary and whether it is used to skirt FDA oversight, trial attorney Gary Alan Friedman said. In a statement, PhRMA said "the compounding company identified in the recent meningitis outbreak is not an FDA-regulated manufacturer, although the scope of this company's distribution of compounded products would seem to require consistent regulation to allow for the best possible care and safety of patients." Pew Charitable Trusts medical specialist Allan Coukell said, "We need to look very carefully at what quality control standards are in place." The Tennessean (Nashville) (tiered subscription model) (11/13) Email this Story
  • FDA didn't clearly establish authority over drug compounders
    The FDA has failed to establish clear enforcement policies related to compounding pharmacies because it was focused on expanding rather than defining its authority, write former FDA Deputy Commissioner Dr. Scott Gottlieb of the American Enterprise Institute and former FDA Chief Counsel Sheldon Bradshaw. The FDA has seldom drawn clear lines between practices over which it clearly has authority and ones that are legal and beyond its scope, they write. Congress should order the FDA to issue regulations that affirm the authorities it already possesses, according to Bradshaw and Gottlieb. The Wall Street Journal (11/13) Email this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Global Focus 
  Food & Dietary Supplements 
  • Iowa company pulls undercooked sausages
    Pinnacle Foods Group recalled 90,975 pounds of bourbon sausages after discovering that the products were undercooked during processing. Walmart is so far the only retailer known to have bought the product based on information from the USDA's Food Safety and Inspection Service. (11/14) Email this Story
  Medical Devices 
  • FDA restricts U.S. import of Hospira's Symbiq infusion pumps
    Hospira has received an FDA notice restricting the importation into the U.S. of its Symbiq drug infusion systems, which are produced in Costa Rica. Hospira said the FDA restriction does not cover imports of its other drug management products and will not have a material effect on the company's ability to meet its financial targets for this year. Reuters (11/14) Email this Story
  • FDA approves abdominal stent graft from Trivascular
    The FDA has granted Trivascular premarket approval for the Ovation stent graft, which is intended to treat weak, bulging or diseased parts of the artery wall in patients undergoing endovascular repair. The approval comes a year after the company received humanitarian device exemption for use of the system in certain patients. (Boston) (11/12) Email this Story
  • FDA approves U.S. study of Kips Bay Medical's surgical mesh
    The FDA has granted Kips Bay Medical investigational device exemption approval to test the use of its eSVS mesh in patients undergoing coronary artery bypass graft surgery. The conditional approval allows the company to add four U.S. clinical sites to an ongoing clinical trial of the device, which is used during CABG procedures to aid in keeping vein grafts open. (Boston) (11/12) Email this Story
  FDLI Items 
  • FDCA Statutory Supplement, 2012 -- Order your copy of the new edition
    This new 2012 edition is fully updated to reflect the recent amendments to the Federal Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed into law by President Obama in July 2012, FDASIA includes the Prescription Drug User Fee Act (PDUFA) V, the Medical Device User Fee Act (MDUFA) III, the Generic Drug User Fee Act (GDUFA) and the Biosimilars User Fee Act (BsUFA) as well as a number of other changes. These amendments are presented in track changes (additions are underlined; deletions are struck-through), making it easy to identify updates and changes to the law. Order now. Email this Story

  • New 3rd Edition -- Off Label: A Guide to Sales & Marketing Compliance
    Do you want to make sure that your company or clients understand the complicated FDA regulations for advertising and promoting pharmaceutical products? The third edition of FDLI's best-selling Off-Label Communications: A Guide to Sales & Marketing Compliance is a comprehensive, practical guidebook on how to comply with the often changing world of off-label regulation, litigation and policy. Email this Story
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Position TitleCompany NameLocation
Attorney ISMC/MHS Contracts Team ManagerMcKesson CorporationSan Francisco, CA
PCH Planning & Reporting MgrPfizer inc.Manila, Philippines
Regulatory CounselBecton DickinsonFranklin Lakes, NJ
Regulatory Counsel, GlobalConfidentialNorthern, NJ
Sr. Brand AttorneyNovo NordiskPrinceton, NJ
Senior Counsel - Regulatory and Quality Assurance ComplianceThe Procter & Gamble CompanyCincinnati, OH
Health & FDA Business AssociateGreenberg TraurigWashington, DC
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--Brendan Francis Behan,
Irish writer

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