Weekly Roundup 4.11.14

A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already the grass appears to be putting forth bright green shoots.  The birds are noisy.

Transitions happen before we know it.  One minute we are complaining about snow and the next, there is a pollen alert.  Here are some news items to mark our way down the path:

  • FDA Expands Indication for Some Pacemakers and Defibrillators –   FDA approved an expanded indication for two pacemakers and eight defibrillators for use in patients with less severe heart failure.  The devices had been approved for severe heart failure use.  The agency spokesperson stated this could delay the occurrence of heart failure related urgent care for people who meet the new criteria.  The devices are manufactured by Medtronic.
  • Internet Ad Spending Beats Broadcast TV Last Year – For the first time it was reported by Mashable that revenue spent on advertising on the Internet surpassed that spent on broadcast television.  Not sure if that is true for the pharma industry or not, but it certainly signals that if not yet, it will likely be soon.  And for FDA, it signals that enforcement efforts, long centered by OPDP on broadcast, need to be approaching their efforts in new ways, taking into consideration a lot of new factors.
  • Predictability and Transparency in DEA and FDA Regulation – On April 7, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, provided a statement before the House Subcommittee on Health, Committee on Energy and Commerce that outlines and explains some of the massively complicated situation regarding the regulation of sunscreens.  One might not think that the oversight of sunscreens could possibly be so involved, but if you want to gaze into the labyrinth, by all means, take a look.
  • And a Timely Alert About Lillies – In time for the Easter Season, FDA has provided an alert about the fact that kitties and lillies may not mix very well. According to the agency, the entire plant – leaf, pollen and flower – are all toxic to our feline friends.  Symptoms can include lethargy, vomiting and loss of appetite which can worsen as kidneys are affected and can prove fatal and early treatment is extremely important.

That’s it for me this week.  I am finally for the first time in many weeks not on the road, so I will be more regular in this space.  Have a good weekend everyone.

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