Weekly Roundup – 11-1-13

We are in the last two months of 2013.  Because in my head it is still 1997, I find this hard to wrap my head around.  But not even a government shut down makes time stand still.  It is November 1 – long shadows are cast in the mid-afternoons and after this week, what will be do with a day shorter of daylight?  Today, there are a lot of kids all hopped up on sugar out there.  A lot of us left holding candy that didn’t get handed out. What happens to that every year?  So many questions….

And if you have questions about what happened this week, here are at least a few things:

  • FDA Announces Steps to Curb Drug Shortages – You may recall a few years back when the subject of drug shortages for critical drugs were in short supply, prompting an Executive Order from President Obama in 2011.  This week FDA announced two actions that the agency was taking to address drug shortages.  The first is a strategic plan which was called for in the Food andDrug Administration Safety and Innovation Act (FDASIA) passed in 2012.  According to the release, the plan is to work with manufacturers to promote sustained quality manufacturing.  The second action involved the issuance of a proposed rule that requires manufacturers to notify the agency of any permanent discontinuance, which was also part of the Executive Order.  There is a separate docket that has been established for the public to provide comment on the proposed rule that will apparently be open next week.
  • Not Very Good News About Spices – The Center for Food Safety and Nutrition (CFSAN) released a constituent update regarding the development of a draft risk profile on pathogens and filth in spices.  This risk profile was put together in the wake of recent outbreaks of human illness from Salmonella contaminated spices and suggests new mitigation and control options.  The study identified 14 outbreaks worldwide that were associated with spices occurring from 1973-2010.  You can read a copy of the report here and apparently provide commentary next week here.
  • FDA’s Role in Personalized Medicine – Sometimes I come across something on FDA’s site that is new to me, but I’m not sure whether it is really new or not since the agency typically does not date material, which is unfortunate. However, what they do tag on is a notice about when the page was last updated. Here is a handy overview of how the agency perceives its role in the developing world of personalized medicine, and the page was last updated 10/29/13 – so even if, unlike me, you are already familiar with this page, there is at least something new on it.

That’s it for me this week everyone.  I hope you manage ok with your leftover candy.  And for those of you in the northern hemisphere, have a lovely autumn weekend.

Photo by Anne Becker

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