Weekly Roundup – 4-26-13

The spring clothes are headed to the closet, while the winter clothes are headed to their space for their seasonal slumber until next Fall.  The days are sunny. The winter mess in the yard has been cleared away (mostly) and new grass seed laid down.  Cicadas will shortly be visiting the mid-Atlantic states….

Meanwhile, here is a bit of what happened in our world this week:

  • FDA Launches Effort to Protect Against Counterfeit Malaria Meds – This week, FDA announced the launch of a partnership to protect against counterfeit anti-malarial medications involving the use of a handheld detection tool developed by FDA called CD-3.  The public-private partnership is with the Skoll Global Threats Fund, the U.S. Pharmaceopeia, the National Institutes of Health, the Centers for Disease Control and Prevention, the President’s Malaria Initiative, and the U.S. Agency for International Development.  FDA said that the tool can detect falsified product, which can contain reduced amounts of drug that can result in the emergence of resistant strains, thereby posing a public health threat.  The agency is working on improving CD-3 with additional refinements.
  • Senate HELP Committee Seeks Input into Draft Compounding Legislation – In the wake of continuing high profile issues related to compounding, the Senate HELP Committee drugs are new drugs subject to FDA jurisdiction; defines FDA’s role in oversight of manufacturers and sets up a user fee type system to fund inspections; and defines roles between states and the federal regulatory authorities.   A link to the draft legislation is included on the newly created Eye on FDA tab that compiles resources related to the developing issues around compounding located on the blog.
  • Dr. Hamburg Opens Up FDLI Conference – Cites Budget Situation – Once again, FDA Commissioner Margaret A. Hamburg opened up the FDLI Conference here in Washington this week with an address that provided a comprehensive look at current agency activities and priorities.  She noted that the times are challenging, though the challenges traditionally faced by an agency with such a large mandate is “made all he more difficult as we seek to fulfill our mission with the added pressure of the ‘new austerity’.”  She said that FDA stands to lose approximately 209 million dollars this fiscal year – with $126 million in budget authority and $83 million of that in user fees because although the fees will continue to be collected, they will remain deposited with the U.S. Treasury.  She also provided overviews on the status of implementation of key legislation such as the Family Smoking Prevention and Tobacco Control Act of 2009, the Food Safety Modernization Act and FDASIA as well as discussing aspects of the compounding issue.

That’s it for me this week.  Get those closets switched around everyone.

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