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February 6, 2013News for the food and drug law community

  Drugs & Biologics 
  • Sanofi-Regeneron's Zaltrap wins EU approval for colon cancer
    The European Commission approved the use of Sanofi and Regeneron Pharmaceuticals' Zaltrap, or aflibercept, in combination with irinotecan, 5-fluorouracil and leucovorin to treat patients with metastatic colorectal cancer who don't respond to an oxaliplatin-containing treatment regimen. The decision was based on the VELOUR study, which showed that combining Zaltrap with chemotherapy significantly prolonged survival. PharmaTimes (U.K.) (2/5) Email this Story
  • Opinion: CDC should lead fight against fake TB meds
    The CDC is best suited to spearhead efforts in combating fraudulent and substandard tuberculosis treatments, American Enterprise Institute resident scholar Roger Bate writes. The agency should collaborate with the World Bank and the State Department's Office of Global Health Diplomacy to help drugmakers, governments and law enforcement curb the production of substandard treatments and fortify drug supply chains, Bate writes. Furthermore, producers of deadly counterfeits should be prosecuted. The New York Times (tiered subscription model) (2/5) Email this Story
  • 2 lawmakers reintroduce bill that would ban patent settlements
    Sens. Amy Klobuchar, D-Minn., and Chuck Grassley, R-Iowa, reintroduced legislation that would prohibit settlements between drugmakers that block the entry of less costly generic treatments. "I have long supported efforts to crack down on this behavior and the recent rise in [patent settlements] underscores the need for legislation to help make sure people have access to the drugs they need at a price they can afford," Klobuchar said. Generic Pharmaceutical Association CEO Ralph Neas said the measure lacks enough support to get through Congress and that despite the arguments against them, "patent settlements reduce save." Reuters (2/5) Email this Story
  Global Focus 
  • EU antitrust regulators scrutinize J&J, Novartis units
    The European Commission has taken formal steps to advance an antitrust investigation involving subsidiaries of Johnson & Johnson and Novartis concerning the painkiller fentanyl. "If our preliminary conclusions are confirmed, the Dutch subsidiaries of Johnson & Johnson and Novartis entered into a so-called 'co-promotion' agreement to avoid competing against each other, depriving users of fentanyl in the Netherlands from access to a cheaper pain killer," an EC official said in a statement. Both companies said they acted properly, and they will have the opportunity to examine the EC's files, make comments and seek a hearing. (2/4), The New York Times (tiered subscription model) (1/31) Email this Story
  • Withdrawal of EU medtech symbols standard leaves regulatory gap
    The removal of the harmonized symbols medtech standard in Europe, known as EN 980, has created a gap in the European regulatory standards framework. EN 980 was expected to be replaced by the global standard ISO 15223-1 of 2012; however, that standard hasn't been harmonized for application in Europe. An official said the regulatory vacuum "was unintentional and will be put right at the next harmonized standard listing publication." Clinica (subscription required) (2/5) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • House GOP leader reiterates stance against medical device tax
    Measures included in the health care law made development of new drugs and patient access to crucial medical technologies tougher, said House Majority Leader Eric Cantor, R-Va., while speaking at the American Enterprise Institute. "If we want to reverse this trend, we should start by choosing to repeal the new taxes that are increasing the costs of health care and health insurance, like the medical device tax," he said. (Boston) (2/5) Email this Story
  FDLI Items 
  • Compounding: Join the discussion on Feb. 12 -- phone option available
    With newly proposed legislation, the courts split, and statutory authority at issue, this is the ideal time for stakeholders to convene, communicate, and explore "what's next" in compounding oversight. Join FDLI for our upcoming program -- Pharmacy Compounding: An FDLI Dialogue-- on Feb. 12 in Washington, D.C. During the first panel, Regulation of Pharmacy Compounding: Historical Analysis, panelists will lead an interactive discussion on the historical framework of the regulation of pharmacy compounding. Panelists include:
    • Douglas B. Farquhar, director, Hymann, Phelps & McNamara P.C.
    • Casey Kozlowski, R.Ph., M.B.A., director, retail ancillary services, Walgreen Co.
    • William A. McConagha, partner, Sidley Austin LLP

  • Medical Device Compliance, Regulation and Litigation Conference -- March 4 -- CDRH confirmed
    At this conference, now in its second year, attendees will hear Carolyn "Cassie" Scherer, policy adviser, office of the center director, CDRH, FDA, and Mary Weick-Brady, senior policy adviser, office of the center director, CDRH, FDA, discuss in detail the most significant recent and upcoming medical device compliance, regulatory and enforcement actions. Additionally, legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. Register now and save $100.
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
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FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory AffairsFood and Drug AdministrationRockville, MD
FDA/ORA/Regional Food and Drug DirectorFood and Drug Administration/Office of Regulatory AffairsMultiple Locations, United States
Food and Drug AssociateHunton & Williams LLPWashington, DC
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--Herman Melville,
American writer and poet

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