Weekly Roundup – 8/21/09

J0406536 The ground is baked hard and each day brings a serious threat of thunderstorms.  The days are long and humid and the garden has had it.  Even the tourists move with a sluggishness that alone indicates that the month in Washington is August and meanwhile around the country all the heat is about health care reform, fact and fiction.  It has been a number of weeks since I've posted a Weekly Roundup, so this one may be more like a monthly roundup.  Even though it is vacation time for most, that hasn't stopped the wheel of progress, and there have been many changes worth reviewing.

  • FDA Launches New Tobacco Oversight Office – As part of its new authority to regulate the marketing of tobacco products, the FDA has created a new Center for Tobacco Products.  The Center will be headed by Lawrence Deyton, M.D., M.S.P.H. who is an expert on veterans' and public health, tobacco use and is a clinical professor at the George Washington University School of Medicine and is the former Chief Public Health and Environmental Hazards officer at the Department of Veterans Affairs.  Setting up the Center was the first step to fulfill the aims of the authorizing legislation which was only signed in June.  Future milestones are laid out in a FAQ and include the prohibition of candy, fruit and spice flavors in cigarettes by October 2009 and by January 2010 manufacturers and importers will have to submit information about ingredients and additives in tobacco products, though there is no specification as to how extensive that reporting will be and FDA inexplicably will wait four full years from the signing of the bill to publish of harmful and potentially harmful ingredients by brand and quantity.  By April 2010 the FDA will reissue a 1996 regulation aimed at reducing tobacco use by the young and by July 2010, manufacturers will no longer be able to advertise "lights" "mild" or "low" related to nicotine and tar content.  The time-line pegs a whole 3 years to strenghten the warning labels for cigarettes.  There is no mention of returning to a time when the tar and nicotine content were on the labels of cigarettes.  
  • FDA Proposes Mandatory Electronic Safety Reporting  Since many companies already use electronic reporting, it is not clear what impact the new proposal to require electronic safety reporting will have, but nevertheless, the FDA announced yesterday that they propose to make such electronic reporting a requirement.  Accordingly the agency issued two new rules – one for drugs and biologics and one for devices, to make e-reporting mandatory – without changing the content of what needs to be reported.  According to the agency, most of the reports it receives on devices have been paper reports, which require extra resources and time to process and handle.    
  • Flu.Gov Provides Communications Toolkit for Businesses and Employers – The government this week provided a comprehensive communications kit for businesses to help prepare for the 2009-2010 flu season, which could be an unusually complicated one potentially involving widespread H1N1 with a seasonal outbreak and the possible lack of vaccine availability  for the former.  The kit includes fact sheets for employers, posters  and template emails as well as text messages and additional communications resources.  I would personally add to the mix with my own recommendations for starting up internal RSS feeds to communicate with key employees, internal twitter capacity and, pursuant to my earlier postings this week, consideration to early adoption of Google Wave as a communications tool to help functioning during any "social distancing" periods that could happen in a serious pandemic.  Might be a good time to revisit my May 2009 Webinar on Pandemic Planning – This is Not a Drill

 Also, if you haven't I highly recommend that you watch the new Commissioner's speech on her vision for FDA.  You can watch it in one sitting at the FDA site, or I have broken it up into four viewings on the EyeonFDA YouTube channel.  

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