Weekly Roundup 1-3-14

What?  A Weekly Roundup after such a short quiet week?   And a week when there was a snow storm to boot?  Even these sheepdogs can’t find the sheep to round up!  Well it may have seemed like a quiet, uneventful week, but a few things of note did happen, so why not round them up?

  • FDA Issues Consumer Update on Supplements and Concussions – On New Year’s Eve FDA issued a Consumer Update entitled “Can a Dietary Supplement Treat a Concussion?  No.” The agency was concerned that makers of some supplements were making claims that their products could aid in recovery from traumatic brain injuries (TBIs) when, as FDA pointed out, there is growing evidence that resumption of strenuous activity too soon after an injury can have a greater chance of risking a subsequent concussion.  It is apparently not the first time the issue has come up, with FDA having issued letters around similar circumstances in 2012, but the agency did issue a warning letter related to the latest claims.
  • FDA Posts Tentative AdComm Calendar – Sort of – Near the end of every year, FDA posts a listing of tentative dates for the coming year for all of the advisory committees that provide the agency with input into product approval and policy decisions.  Getting that insight into the schedule gives one an idea of what therapeutic categories are likely going to have issues or products to discuss – so that if the Oncology Drugs Advisory Committee (ODAC), for example, has several dates set, it signals the possibility of a number of products coming from the pipeline.  But the AdComm tentative dates schedule for 2014 did not come out by year’s end and only got published this week.  Even so, one can see that only some of the committees have tentative meetings scheduled and even then, it is usually only for one date.  Hopefully the schedule will fill out as time goes by.
  • Risk Communications AdComm – And speaking of Consumer Updates, FDA announced this week a meeting of the Risk Communications Advisory Committee for February 3 and 4 to discuss how FDA can evaluate whether its “Consumer Updates” are reaching the targeted population and whether they are increasing awareness and understanding of the key risk messages.  The agency says that the discussion will assess whether the communications are having the intended impact on knowledge, behaviors and outcomes.  I hope to be able to attend this meeting and will report out on it.

See?  Stuff did happen this week.  If you are in part of the country that got walloped by the snowstorm, I hope you are safe and warm with comfort food close at hand.  Wherever you are, have a wonderful weekend.

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