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November 8, 2012News for the food and drug law community

  Drugs & Biologics 
  • Expert: Hamburg's continued role as FDA chief is good for drugmakers
    The pharmaceutical and biotech industry will benefit from the presumed continuation of Dr. Margaret Hamburg as FDA commissioner in President Barack Obama's second term, GlycoMimetics CEO and Biotechnology Industry Organization board member Rachel King said. "The consistency is positive," said King, who points to advances in the latest Prescription Drug User Fee Act, including the new "breakthrough therapies" designation, improved communication between drugmakers and the agency, and the expansion of accelerated approval. American City Business Journals/Washington, D.C. (11/7) Email this Story
  • Drug industry debates use of citizen petitions to block generics
    The pharmaceutical industry is debating the use of citizen petitions as a means to challenge generic competitors, which in turn file petitions against new versions of previously approved brand-name treatments. "Citizen petitions are consistent with the First Amendment right to petition the government, and even large companies have that right," said Rutgers-Camden law professor Michael A. Carrier, a co-author of a paper on the topic. The Philadelphia Inquirer (11/7) Email this Story
  • Mass. ousts Coffey as pharmacy board chief
    The Massachusetts Department of Public Health dismissed James Coffey as director of the state's pharmacy board for not following up on a Colorado pharmacy board complaint accusing the New England Compounding Center of selling treatments without a prescription. Coffey's inaction was "incomprehensible," said Lauren Smith, the health department's interim leader. The Wall Street Journal (11/7) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  • Unsanitary conditions prompt closure of pizza vendor in Seattle
    The Veraci Pizza at Seattle's Ballard Farmers Market was closed after King County and Seattle Health Department officials found several unsanitary conditions. The violations include lack of handwashing facilities, the employees' poor personal hygiene practices and unsafe temperatures for potentially hazardous foods. (11/7) Email this Story
  Medical Devices 
  • Medtech industry seeks lame-duck session repeal of device tax
    Industry stakeholders are bracing for post-election efforts to strike down the 2.3% tax set to be levied against medical devices next year. "[W]e will continue to work to highlight what we think are the negatives of the policy for the industry," said J.C. Scott of the Advanced Medical Technology Association, who noted support from House Democrats and incoming Democratic senators for a repeal of the tax. FierceMedicalDevices (11/7) Email this Story
  • Mini sinus implant from Intersect gains FDA approval
    The FDA has granted Intersect ENT approval for its Propel mini implant, a second-generation, smaller version of its steroid-eluting device designed to treat patients with chronic sinusitis. The company plans a limited U.S. launch of the device this month and a nationwide release next year. (Boston) (11/6) Email this Story
  • Consultant calls for legislation that would clarify device tax
    The proposed 2.3% tax on medical devices is likely to survive with President Barack Obama's re-election and possible Democratic retention of the Senate, but the levy needs clarification, Gunter Wessels of consulting firm Total Innovation Group said. Introducing a bill that would clarify issues such as who is required to pay the levy is the best approach going forward, he said. (11/7) Email this Story
  • LDR closer to FDA approval for cervical disc device
    The FDA has issued an approvable letter to LDR for its Mobi-C system, a metal and polyethylene mobile bearing prosthetic device tailored for use in one- to two-level cervical disc replacement procedures. The company expects to satisfy the remaining approval requirements and release the device in the U.S. next year. (11/7) Email this Story
  • Voters reject 73-cent tobacco hike in Mo.
    In Missouri, voters rejected a 73-cent hike on the tobacco tax 50.8% to 49.2%, with a margin of 43,000 votes. The result could be credited "to our ability to communicate with voters through our convenience-store education program," said Ron Leone of the Missouri Petroleum Marketers and Convenience Store Association. St. Louis Post-Dispatch (11/6), St. Louis Beacon (11/7) Email this Story
  FDLI Items 
  • Explore current & future FDA policy of nanotechnology law & regulation, Dec.4
    Dec. 4th is FDLI's conference on Nanotechnology Law, Regulation and Policy. If you are a stakeholder involved in nanotechnology manufacturing, this is a must-attend program. Attendees will hear directly from leading experts in the field of nanotechnology and participate in an interactive roundtable with key stakeholders. Registration is open. Take advantage of early bird pricing through Nov. 16. Email this Story

  • 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
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Position TitleCompany NameLocation
FDA Regulatory AssociateArnold & Porter LLPWashington, DC
Regulatory CounselBecton DickinsonFranklin Lakes, NJ
Regulatory Counsel, GlobalConfidentialNorthern, NJ
Senior Counsel - Regulatory and Quality Assurance ComplianceThe Procter & Gamble CompanyCincinnati, OH
Sr. Brand AttorneyNovo NordiskPrinceton, NJ
Health & FDA Business AssociateGreenberg TraurigWashington, DC
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People always call it luck when you've acted more sensibly than they have."
--Anne Tyler,
American novelist

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