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March 8, 2013News for the food and drug law community

  Drugs & Biologics 
  • Flu vaccine strains endorsed by FDA panel for 2013-2014
    The FDA's Vaccines and Related Biological Products Advisory Committee endorsed a slightly different influenza vaccine composition for the 2013-2014 flu season, compared with that of the previous season. The committee recommended substituting two vaccine strains while retaining the A/California/7/2009pdm09-like virus. The committee also released recommendations for quadrivalent vaccines, noting that "global influenza virus surveillance data related to epidemiology and antigenic characteristics, serological responses to 2012-2013 seasonal vaccines, and the availability of candidate strains and reagents" were used as the basis for the recommendations. Medscape (free registration) (3/7) Email this Story
  • Uncertainty hits FDA after narcolepsy risk tied to GSK vaccine
    The FDA is facing the challenge of approving a drug similar to GlaxoSmithKline's Pandemrix to treat H5N1 bird flu pandemic following evidence linking the vaccine to higher narcolepsy cases in children who received it in Europe. A study in the British Medical Journal found that U.K. children who got the vaccine during the H1N1 swine flu pandemic in 2009-2010 were 14 times more likely to have the condition than those who didn't receive the treatment. The findings mirror results from similar trials in Ireland, Finland and Sweden. Reuters (3/7) Email this Story
  • GSK seeks EU approval for diabetes drug albiglutide
    GlaxoSmithKline submitted an application to the European Medicines Agency for approval to market its diabetes drug albiglutide. The once-weekly drug belongs to the same class as Novo Nordisk's Victoza and Amylin Pharmaceuticals' Byetta and Bydureon. Yahoo/Reuters (3/7) Email this Story
  • NICE plans to recommend Novartis' Xolair to treat severe asthma
    The U.K. National Institute for Health and Clinical Excellence is planning to endorse severe asthma treatment Xolair from Novartis, reversing a decision it made last year because of a discount plan proposed by the drugmaker. The decision was welcomed by asthma campaign groups. Asthma UK's Samantha Walker said "Xolair is the only treatment that works for some people with severe allergic asthma who would otherwise be virtually housebound because of breathlessness and living in constant fear of the next asthma attack." Reuters (3/6) Email this Story
  • FDA's Rick Blumberg dies
    Eric "Rick" Blumberg, the deputy chief counsel for litigation at the FDA, has died. Blumberg had a 42-year career with the agency. "Rick’s dedication to the agency over a 42-year career, and to the effective use of the law to protect the public, was widely recognized," said the FDA's Chief Counsel Liz Dickinson. "Fearless, kind-hearted and brilliant, he nurtured the careers of dozens of food and drug lawyers who carry on his legacy in the government and beyond." Regulatory Focus (3/7) Email this Story
  Food & Dietary Supplements 
  • Lawmaker proposes bill to act against seafood fraud
    A bipartisan version of the Safety and Fraud Enforcement for Seafood Act that would prevent seafood fraud in the country was recently proposed by Rep. Ed Markey, D-Mass. Aside from enhancing the transparency in the seafood supply chain, the SAFE Seafood Act would also boost the ability of the National Oceanic and Atmospheric Administration and the FDA to stop fraudulent shipments of seafood from entering the U.S. market. (3/8) Email this Story
  Medical Devices 
  • Vital Images' TAVR planning app lands 510(k) clearance
    The FDA has cleared Vital Images, a Toshiba Medical Systems unit, to market a planning application for transcatheter aortic valve replacements. The CT TAVR planning app allows doctors to image and measure the vascular anatomies of patients with aortic vascular disorders to guide the diagnosis, treatment and follow-up planning process. (3/7) Email this Story
  • Ignoring new cigarette applications doesn't promote health
    The FDA's decision to ignore applications for new cigarette brands is more of a market intervention rather than a promotion of public health, Jacob Grier writes. The FDA's approval process, which is marked by slow and unclear progress and lack of potential, has held hostage about 500 products submitted for review since the new tobacco rules' implementation in March 2011. The Atlantic online (3/6) Email this Story
  FDLI Items 
  • New Policy Forum on sunscreen
    What is the Best Way for Manufacturers and Physicians to Apply Sunscreen to Avoid Being Burned by the Final Sunshine Act Regulations? This issue of our Policy Forum explains the requirements under the Patient Protection and Affordable Health Care Act's Physician Payment Sunshine Act that all medical product manufacturers report to HHS any payment or transfer of value made to physicians and teaching hospitals. Author Abraham Gitterman, research associate at Rockpointe, warns that manufacturers may face adverse consequences of public access to payment data, including fraud and abuse investigations and private litigation actions. He recommends that manufacturers begin training employees to ensure compliance with the statute and reduce the likelihood of further investigations. He further suggests that if CMS' implementation of the Sunshine Act stigmatizes collaborations between physicians and industry, medical progress will be slowed and patients will be harmed. Email this Story
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