Weekly Roundup 11.7.14

It is a lovely autumn in our nation’s capital – at least looking at the trees and the light.  It is always remarkable how the light angles change and the sun will suddenly appear beneath clouds instead of over them to give us colorful beautiful sunsets.  And in this busy, busy time of year, it is good to have a steady supply of lovely colors to remind us of how good it feels just to experience the moment rather than be caught up in the future or the past.

But here are a few moments from this past week for you to ponder in case you are challenged to stay in the moment:

  • OPDP Issues Untitled Letter – In what has been a record-low year for Warning and Untitled Letters out of FDA’s Office of Prescription Drug Promotion (OPDP), a letter was posted this week – only the 9th of the year.  The letter involved a sales aid where the agency found that while some risk information was included, all of the contraindications were omitted as well as other important risk information and reminded us that further risk information cannot be incorporated by reference.  The agency also found the way in which the product was positioned for its uniqueness also suggested that the product was safer and more effective.
  • Ups and Downs of ODAC – In a vote of 8-3, members of the Oncologic Drugs Advisory Committee recommended that FDA approve Triferic for the treatment of iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease.  The vote of the committee is a recommendation which FDA may or may not follow.  The PDUFA date for deciding on approval is January 24, 2015.  On another note, the same panel voted down a proposed treatment – a pan-deacetylase (pan-DAC) inhibitor – for multiple myeloma 5-2.

FDA has been very quiet of late.  No press releases this month.  No speeches.  No testimonies.  And so that’s it for me this week.  Have a good weekend everyone.

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