Weekly Roundup 6.10.16

We are finally getting some weather that could be described as delightful.  I hope that you are too. The grass is green, a breeze blows and there is lots of birdsong in the air. For the first time in years, my little shade garden is not embarrassing.

More importantly, on the FDA front, there were a few official developments and here were a few outside of FDA activities that were of note. Here are a few:

  • FDA Sweep on Illegal Internet Sales – Speaking of roundups, there was the annual International Week of Action in the form of Operation Pangea which every year gets a Roman numeral after it and this one was IX. It is the time of year when FDA and other international agencies coordinate to reduce illegal sales of unapproved prescription medications over the Internet. As part of the effort, FDA said in its release that it requested the suspension of over 4400 sites and issued over 50 warning letters. It is perhaps notable that in the release regarding Operation Pangea VIII last year, the agency said that it sent warning letters to operators of over 400 sites, but said that it took action against more than 1000 sites.
  • Another Biosimilar AdComm Set – Another AdComm Calls it Quits – An FDA AdComm has been set for July 13 to consider another New Drug Application for a biosimilar, this time where the reference product is Enbrel. A meeting of the Arthritis Drugs Advisory Committee has been scheduled for July 13 to consider several indication for the biosimilar candidate. And in other AdComm news, FDA announced this week that it was terminating (such a choice of words!) the Transmissible Spongiform Encephalopathies AdComm due to lack of issues and corresponding need for advice on the part of FDA.
  • Vermont Governor Signs Transparency Pricing Bill into Law – Governor Peter Shumlin of Vermont signed into law this week a first-of-its kind bill that would require greater transparency on the part of manufacturers when raising the price of a prescription medication. The press release from the Governor’s office states that there will be a list of the top 15 price increases each year and that manufacturers will be responsible for justifying those increases to the Attorney General’s office.

That’s it for me this week folks. I hope to have some information for you next week to update you on the use of Twitter by pharma. Until then, have a great weekend.

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